News & Announcements

2017


NATCO receives final approval for Generic Bendamustine HCl Powder for USA Market 06 January 2017

NATCO receives final approval for Generic Bendamustine HCl Powder for USA Market

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic version of Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial). Pursuant to the settlement of the Paragraph IV litigation, NATCO plans to launch this drug on November 1, 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical, Inc., in the USA market. Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers.

Cephalon (acquired by Teva in 2011) sells Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial) under Brand name TREANDA® in the USA market. TREANDA® is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. TREANDA® had U.S. sales of approximately $133 Million for twelve months ending November, 2016, according to IMS Health.


NATCO launches VELPANAT in Nepal - 1st generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination medicine in the country 02 January 2017

NATCO launches VELPANAT in Nepal -  1st generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination medicine in the country

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched the first generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination in Nepal. Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination is sold by Gilead Sciences, Inc., under brand name Epclusa®.

Epclusa® is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for Ribavirin.

Natco will market Sofosbuvir 400mg/Velpatasvir 100mg under the brand name VELPANAT®. Natco priced its generic medicine of VELPANAT at an MRP of INR 25,000/- equivalent for a bottle of 28 tablets in Nepal. Natco has signed a non-exclusive licensing agreement with Gilead Sciences, Inc., to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries.


2016


NATCO launches the first generic equivalent of TAMIFLU® Capsules in the USA market 12 December 2016

NATCO launches the first generic equivalent of TAMIFLU® Capsules in the USA market

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce launch of the first generic equivalent of TAMIFLU® oral capsules (Roche’s trade name for oseltamivir phosphate capsules), 30 mg, 45 mg and 75 mg through its marketing partner Alvogen in the USA market, as of December 12th, 2016.

TAMIFLU® oral capsules had U.S. sales of approximately $403 Million for twelve months ending December 2015, according to IMS Health.

*Tamiflu is a US registered trademark of Hoffman La-Roche Inc. Corporation. Natco and Alvogen are not affiliated with Hoffman La-Roche Inc.


NATCO receives final approval for Generic Armodafinil tablets for USA market 29 November 2016

NATCO receives final approval for Generic Armodafinil tablets for USA market

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic version of Armodafinil Tablets, 50 mg, 150 mg, and 250 mg .  NATCO and its marketing partner Breckenridge Pharmaceutical, Inc., plan to launch this product in the USA market immediately.

Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg Tablets under Brand name NUVUGIL® in the USA market. NUVUGIL® is a wakefulness promoting agent for oral administration.  NUVUGIL® Tablets had U.S. sales of approximately $480 Million for twelve months ending December 2015, according to IMS Health.


NATCO receives final approval for generic Budesonide Capsules, 3 mg, for USA market 24 November 2016

NATCO receives final approval for generic Budesonide Capsules, 3 mg, for USA market

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for generic version of Budesonide Capsules (Enteric Coated), 3 mg . NATCO and its marketing partner Alvogen plan to launch this product in the USA market immediately.

Perrigo Pharma International DAC sells Budesonide Capsules under their brand ENTOCORT® in the USA market. ENTOCORT® EC Capsules, 3 mg, and its generic versions had U.S. sales of approximately $370 Million for twelve months ending December 2015, according to IMS Health.


NATCO records INR 467.86 Crore operating revenue for the Second Quarter, FY 2017, ended September 2016 11 November 2016

NATCO records INR 467.86 Crore operating revenue for the Second Quarter, FY 2017, ended September 2016

Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total income from operations of INR 467.86 Crore for the quarter ended on 30th September, 2016, as against INR 243.02 Crore during the same quarter last year, reflecting an increase of about 92.5%.

The net profit for the period, on a consolidated basis, was INR 65.97 Crore, as against INR 30.28 Crore same quarter last year, showing a growth of 117.9 %. The growth for the company during the quarter was driven primarily by increased sales of its formulation business.


IDFC Securities invites you to the Q2 FY17 Earnings call of NATCO Pharma Limited 08 November 2016

IDFC Securities invites you to the Q2 FY17 Earnings call of NATCO Pharma Limited

Click here for more details


Notice of Board Meeting – November 11th, 2016 01 November 2016

Notice of Board Meeting – November 11th, 2016

A meeting of the Board of Directors of the Company is scheduled to be held on Friday, the 11th November, 2016 at 11.00 a.m. at the Registered Office of the Company to consider among other things, the Unaudited Financial Results for the quarter and half year ended 30th September, 2016 and related matters.

Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 1st  November, 2016 to 13th November, 2016 (both days inclusive).  Trading window will be opened from 14th November, 2016.


NATCO’s marketing partner Mylan Invalidates Third Teva Copaxone®... 02 September 2016

NATCO’s marketing partner Mylan Invalidates Third Teva Copaxone®...

NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of its marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd., unpatentable. This is the third patent related to Copaxone® 40 mg/mL to be found unpatentable in the last week.

On August, 24, 2016 the PTO’s Patent Trial and Appeal Board (PTAB) found Teva’s first two patents, U.S. Patent Nos. are 8,232,250 and 8,399,413, unpatentable in Mylan’s IPR challenge of these patents.

NATCO’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.

Copaxone® 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.


NATCO’s marketing partner Mylan Invalidates Two of Teva's Copaxone®... 25 August 2016

NATCO’s marketing partner Mylan Invalidates Two of Teva

NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that the U.S. Patent and Trademark Office (PTO) has ruled in favour of its marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of two related Copaxone® 40 mg/mL patents to be unpatentable. The U.S. Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan’s third petition seeking inter partes review of U.S. Patent No. 8,969,302 is expected on or before September 1, 2016.

On Aug. 15, the PTO’s Patent Trial and Appeal Board (PTAB) found Mylan’s application against a fourth Copaxone 40 mg/mL patent, U.S. Patent No. 9,155,776, ineligible for post-grant review for procedural reasons. However, Mylan believes that today’s favourable ruling in the IPR against the ‘250 and ‘413 patents strongly undermines the ‘776 patent as well. As such, Mylan will proceed with pursuing all avenues to challenge the ‘776 patent.

NATCO’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete abbreviated new drug application containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.

Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.


NATCO receives Establishment Inspection Report for Chennai facility 25 August 2016

NATCO receives Establishment Inspection Report for Chennai facility

NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce receipt of successful Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted, during the period February 8 – February 12, 2016, at its Chemical Division, Chennai, India (named NATCO Organics Limited, prior to amalgamation into the company).


NATCO receives Establishment Inspection Report for Kothur facility 16 August 2016

NATCO receives Establishment Inspection Report for Kothur facility

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce receipt of successful Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its drug manufacturing facility in Kothur Village, Mahaboob Nagar District, India, during the period February 29 – March 7, 2016.  The Kothur facility predominantly caters to regulated international markets, including USA.


NATCO records INR 325.22 crore operating revenue for the First Quarter, ended June 2016 09 August 2016

NATCO records INR 325.22 crore operating revenue for the First Quarter, ended June 2016

Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated net operating revenues of INR 325.22 Crore for the quarter ended on 30th June, 2016, as against INR 223.71 Crore during the same quarter last year, reflecting an increase of about 45.4%.

The net profit for the period, after tax and minority interest, on a consolidated basis, was INR 47.65 Crore, as against INR 28.07 Crore same quarter last year, showing a growth of 69.8%. The growth for the company was predominantly driven by increased sales of its oncology and hepatitis C products in India.


NATCO RECEIVES FINAL APPROVAL FOR GENERIC TAMIFLU® 04 August 2016

NATCO RECEIVES FINAL APPROVAL FOR GENERIC TAMIFLU®

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic versions of TAMIFLU® oral capsules (Roche’s trade name for Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg. NATCO and its marketing partner Alvogen are the first generic players to receive this approval.

Earlier in December, 2015, NATCO and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. Under the terms of the settlement, NATCO’s partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA’s Orange Book for U.S. Patent No. 5,763,483, which is February 23, 2017.

TAMIFLU® oral capsules had U.S. sales of approximately $403 Million for twelve months ending December 2015, according to IMS Health.


Edelweiss Securities invites you to the Q1 FY17 Earnings call of NATCO Pharma Limited 02 August 2016

Edelweiss Securities invites you to the Q1 FY17 Earnings call of NATCO Pharma Limited

Click here for more Details


Notice of Board Meeting – August 9th, 2016 01 August 2016

Notice of Board Meeting – August 9th, 2016

A meeting of the Board of Directors of the Company is scheduled to be held on Tuesday, 9th August, 2016 at 11.00 a.m. at the Registered Office of the Company to consider among other things, the following items of businesses and related matters:

1. Unaudited financial Results for the quarter ended 30th June, 2016.

2. To Consider Interim Dividend, if any, for the year 2016-17.

3. Convening of 33rd Annual General Meeting for the financial year 2015-16.

4. Consideration of Employee Stock Option Scheme (NATSOP2016) under SEBI (Share Based Employee Benefits) Regulations, 2014.

Please further note that TRADING WINDOW for dealing in the securities of the Company will be closed from 1st August, 2016 to 11th August, 2016 (both days inclusive). Trading window will be opened from 12th August, 2016.


Winner of ‘Golden Peacock Environment Management Award’ for the Year 2016 09 July 2016

Winner of ‘Golden Peacock Environment Management Award’ for the Year 2016

Natco Pharma Limited’s Chemical Division at Mekaguda was declared as the Winner of ‘Golden Peacock Environment Management Award’ for the year 2016.

The award was presented at the Institute of Directors (IOD) India’s “18th World Congress on Environment Management” held on 8, 9th July 2016 at The Ashok Hotel, New Delhi. The theme of the event was “Environment and Climate Change – Transitioning to a Sustainable Economy” and it was attended by a distinguished gathering of diplomats and business leaders.

Mr. PSRK Prasad, Executive Vice President Corp Engineering Services and Mr. Srinivas Rao, Deputy General Manager, Environment Health and Safety, attended the event and received the award on behalf of the Company from Justice (Dr.) Arijit Pasayat, Co-Chairman, Institute Of Directors & former Judge, Supreme Court of India.


NATCO receives USFDA tentative approval for Sorafenib Tablets, 200mg 03 June 2016

NATCO receives USFDA tentative approval for Sorafenib Tablets, 200mg

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that its marketing partner, Mylan Inc. (Nasdaq:MYL), has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the U.S. Food and Drug Administration (USFDA). This product is the generic version of NEXAVAR®, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

NATCO and Mylan have filed an ANDA containing a Paragraph IV certification for this product. NATCO manufactures this product at its facility in Kothur, Mahaboobnagar District, Telangana State, India.

Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR®, in the U.S. market. For the 12 months ending Dec. 31, 2015, NEXAVAR® had U.S. sales of approximately $300 million.(SOURCE: Bayer’s Annual Report)


NATCO records Rs.1152.38 crores net revenues & Rs.155.19 crores net profit after tax, for the year ended March 2016 26 May 2016

NATCO records Rs.1152.38 crores net revenues & Rs.155.19 crores net profit after tax, for the year ended March 2016

The Board of NATCO Pharma Limited (NPL) met in Hyderabad today and adopted the consolidated audited accounts of the company for the year ended 31st March, 2016.

NPL recorded an aggregate of Rs.1152.38 crores in consolidated net revenues for the year ended on 31st March, 2016, as against Rs.840.18 crores for last year, with a year-over-year growth of 37.15% in the topline. The net profit, after tax, on a consolidated basis, was recorded as Rs.155.19 crores for the year ended 31st March, 2016, as against Rs.134.61 for the previous year.

For the fourth quarter (Q4) ended March 31st, 2016, the Company recorded a net revenue of Rs.408.47 crores, on a consolidated basis, as against Rs.204 crores during Q4, FY 2015, posting an increase of about 100%. The profit after tax, on a consolidated basis, was recorded as Rs.60.24 crores for the quarter. The key driver for the accelerated revenue growth was the company’s Hepatitis C portfolio of products in the domestic Indian market.


Edelweiss Securities invites you to the Q4 FY16 Earnings call of NATCO Pharma Limited 23 May 2016

Edelweiss Securities invites you to the Q4 FY16 Earnings call of NATCO Pharma Limited

Click here for more Details


Notice of Board Meeting – May 26th, 2016 11 May 2016

Notice of Board Meeting – May 26th, 2016

A meeting of the Board of Directors of the Company is scheduled to be held on Thursday, May 26th 2016 at 11.00 am at Registered Office of the Company to consider and approve the Audited Financial Results for the Year ended 31st March, 2016.

Please note that the trading window for dealing in the securities of the Company will be closed for Promoters, Directors, Connected Persons, Insiders, Employees and their immediate relatives from 16th May,  2016 to 28th May,  2016 (both days inclusive). It will be opened from 30th May, 2016.


High Court approves amalgamation scheme of NATCO 09 May 2016

High Court approves amalgamation scheme of NATCO

The High Court of Madras vide its Order dated 28th April, 2016, has sanctioned the Scheme of Amalgamation of NATCO Organics Limited, a Wholly Owned Subsidiary of the Company with NATCO Pharma Limited.


NATCO updates on Sale of US Store 07 April 2016

NATCO updates on Sale of US Store

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) completed the transaction of sale of its SAVE MART PHARMACY Store located in USA to CARE MART Inc., for which an agreement was executed. The agreement inter-alia provides for consideration towards goodwill, furniture and fixtures, Inventory etc.


Natco Board approves sale of its Save Mart Store in the USA 30 March 2016

Natco Board approves sale of its Save Mart Store in the USA

The Board of Directors of Natco Pharma Limited at their meeting held on the 30th of March 2016, approved the sale of its Save Mart Pharmacy Store located in the USA.  The Save Mart Pharmacy Store is owned by Natco Pharma Inc., a wholly owned subsidiary of the Company, and is considered as a non-core part of the business.


Natco updates on USFDA Inspection 27 March 2016

Natco updates on USFDA Inspection

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) updated that an inspection was conducted by the United States Food & Drug Administration (USFDA) in two of its manufacturing facilities recently- the Active Pharmaceutical Ingredients (API) manufacturing facility at Manali, near Chennai, and the Pharmaceutical Formulations facility at Kothur, near Hyderabad, during early February and March, 2016, respectively.

The company received Form-483 observations for both facilities and believes them to be of minor in nature. The company has already sent response and compliance report for these observations and believes that there would be no adverse impact to its current or future pipeline products coming from these facilities.


NATCO records Rs.281.40 crores revenue for the Third Quarter, ended December 2015 11 February 2016

NATCO records Rs.281.40 crores revenue for the Third Quarter, ended December 2015

Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.281.40 Crores in consolidated net revenues for the quarter ended on 31st December, 2015, as against Rs.202.80 Crores during the same quarter last year, recording an increase of about 38.75%.

The net profit, after tax, on a consolidated basis, was Rs.37.15 Crores, as against Rs.14.34 Crores same quarter last year that had a one-time exceptional expense. The solid growth in revenue & profit for the quarter was largely driven by domestic formulation business, the revenues for which grew to about Rs.170 crores during Q3 FY16, as opposed to about Rs.62 crores same quarter previous year, reflecting a 175% growth.


Nirmal Bang invites you to the Q3 FY16 Earnings call of NATCO Pharma Limited 08 February 2016

Nirmal Bang  invites you to the Q3 FY16 Earnings call of NATCO Pharma Limited

Click here for more Details


Notice of Board Meeting – February 11th, 2016 30 January 2016

Notice of Board Meeting – February 11th, 2016

This is to inform you that the meeting of the Board of Directors of the Company is scheduled to be held on Thursday, the 11th day of February, 2016 at 11.00 a.m. at Registered Office of the Company to consider among other things, the following:

1. The unaudited financial Results for the quarter and nine months ended 31st December, 2015 and related matters

2. To consider Interim Dividend, if any, for the financial year 2015-16 and related matters etc.

Please further note that TRADING WINDOW for dealing in the securities of the Company will be closed for romoters, Directors, Connected Persons, Insiders, Employees and their immediate relatives from 3rd February, 2016 to 13th ebruary, 2016 (both days inclusive). It will be opened from 15th February, 2016.


NATCO Announces Licensing Agreement for Daclatasvir 21 January 2016

NATCO Announces Licensing Agreement for Daclatasvir

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has signed a nonexclusive, royalty free licensing agreement with the Medicines Patent Pool (MPP) and Bristol-Myers
Squibb to manufacture and sell generic versions of Bristol-Myers Squibb’s chronic hepatitis C
medicine – Daclatasvir Dihydrochloride (Daclatasvir).

Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV)
genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV
patient subsets.

Natco will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India.

This agreement allows Natco to expand access to these chronic hepatitis C medicines in 112 developing countries. Under the license, Natco can set its own price for the generic products it produces.


2015


NATCO announces REVLIMID® Settlement with Celgene 23 December 2015

NATCO announces REVLIMID® Settlement with Celgene

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) and its US partner Allergan announce settlement of its pending litigation with Celgene regarding generic Lenalidomide.

Celgene has agreed to provide Natco with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic Lenalidomide in the United States beginning on January 31, 2026.  In addition, Natco will receive a volume-limited license to sell generic Lenalidomide in the United States commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total Lenalidomide capsules dispensed in the United States during the first full year of entry.  The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total Lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license under this agreement.

REVLIMID® had recorded sales of nearly $3.4 billion in the US market for the year ending September 2015 (Source: Celgene Website).


NATCO receives generic Ledipasvir + Sofosbuvir approval for India 15 December 2015

NATCO receives generic Ledipasvir + Sofosbuvir approval for India

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI®. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies.

NATCO will price its generic medicine, Hepcinat LP, at an MRP of INR 25,000/- for a bottle of 28 tablets. NATCO was the first licensed company to launch the generic version of this combination drug earlier in Nepal. NATCO had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI®, in 100 other developing countries in addition to India.


NATCO RECEIVES GENERIC DACLATASVIR APPROVAL FOR INDIA 14 December 2015

NATCO RECEIVES GENERIC DACLATASVIR APPROVAL FOR INDIA

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is the 1st company in India to get approval for generic Daclatasvir Dihydrochloride (“Daclatasvir”) tablets, 30mg & 60mg, from Drugs Controller General (India). Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets.

Natco will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India. Natco will launch Immediately in India at an MRP of Rs.6000/-(Rupees Six thousand only) and Rs.4000/- (Rupees Four Thousand only) for the 60mg and 30mg strengths, respectively, for a bottle of 28 tablets.


ALVOGEN AND NATCO SETTLE INFRINGEMENT SUIT WITH GILEAD AND OTHERS FOR GENERIC TAMIFLU 14 December 2015

ALVOGEN AND NATCO SETTLE INFRINGEMENT SUIT WITH GILEAD AND OTHERS  FOR GENERIC TAMIFLU

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) and Alvogen, who have partnered on the first Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic versions of Tamiflu® oral capsules (oseltamivir phosphate), 30 mg, 45 mg and 75 mg, announced today that they have settled the patent infringement suit filed by Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. against Alvogen and Natco in New Jersey District Court (2:11-cv-04969-SDW–MCA).

FDA granted tentative approval to NATCO for the generic oseltamivir phosphate capsules on March 14, 2014. Under the terms of the settlement, NATCO’s partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA’s Orange Book for U.S. Patent No. 5,763,483, which is February 23, 2017.


Natco Pharma’s WOS API plant operations at Chennai temporarily suspended due to flooding 02 December 2015

Natco Pharma’s WOS API plant operations at Chennai temporarily suspended due to flooding

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) stated today that its Wholly Owned Subsidiary’s (WOS’s) Active Pharmaceuticals Ingredient (API) Plant at Manali Industrial Area, Chennai, has temporarily suspended operations due to flooding caused by incessant rains in the plant area.

The Unit manufactures a few oncology related APIs at its Manali site. The company believes that this temporary shutdown should not impact/impair its pipeline launches associated with this plant. The Unit is also adequately insured for any losses it has incurred in fixed assets, raw materials and loss in production including work-in-progress. Actual losses will be assessed once this natural calamity passes by, and the plant is back in full operational mode.


Key Managerial Personnel updation 02 December 2015

Key Managerial Personnel updation

Pursuant to Regulatin30 (5) of SEBI (Listing and Obligation Disclosure Requirements) Regulations, 2015, please find below the details of the Key Managerial Personnel who have been jointly severally authorised by the Board of Directors of the Company:

To determine the materiality of an even or information under this regulation and also making disclosures to stock Exchange (s):

Name Designation E-mail Id
Mr. V C Nannapaneni Chairman & Managing Director chairman@natcopharma.co.in
Mr. Rajeev Nannapaneni Vice Chairman & CEO rajeev@natcopharma.co.in
Mr. M. Adinarayana Company Secretary & Vice President (Legal & Corp Affairs) man@natcopharma.co.in
Mr. S.V.V.N. Appa Rao Interim Chief Financial Officer svvn@natcopharma.co.in
Contact Address: NATCO Pharma LimitedNATCO House, Road No.2, Banjara HillsHyderabad 500 034, Telangana
Contact No. 040-23547532

Religare invites you to the Q2 FY16 Earnings call of NATCO Pharma Limited 16 November 2015

Religare invites you to the Q2 FY16 Earnings call of NATCO Pharma Limited

Click Here For More Details


NATCO records Rs.236.97 crores revenue for the Second Quarter, ended September 2015 13 November 2015

NATCO records Rs.236.97 crores revenue for the Second Quarter, ended September 2015

Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.236.97 Crores in consolidated net revenues for the quarter ended on 30th September, 2015, as against Rs.222.42 Crores during the same quarter last year, recording an increase of about 6.6%.

The net profit, after tax, on a consolidated basis, was Rs.29.57 Crores, as against Rs.32.37 Crores same quarter last year. This is a decrease of about 8.6% compared to same quarter last year. The growth in profit for the quarter was constrained due to delay in exports to South America. However, sales of domestic formulation segments, including Sofosbuvir, continue to do well. The company expects stronger sales growth with higher profitability, during H2 of FY2016.


NATCO launches HEPCINAT LP in Nepal 28 October 2015

NATCO launches HEPCINAT LP in Nepal

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched the first licensed generic version of ledipasvir+sofosbuvir combination in Nepal, under its brand name Hepcinat LP.

Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI®. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. NATCO priced its generic medicine, Hepcinat LP, at an MRP of INR 25,000/- for a bottle of 28 tablets in Nepal.

Natco had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI®, in India and other 100 developing countries.


NATCO received the “Best Speciality Brand-SILVER AWARD” for marketing excellence in India, during 2014-15 fiscal year 15 October 2015

NATCO received the “Best Speciality Brand-SILVER AWARD” for marketing excellence in India, during 2014-15 fiscal year

NATCO received the “Best Speciality Brand-SILVER AWARD” for marketing excellence in India, during 2014-15 fiscal year, for one of its flagship oncology brands – ERLONAT, by AWACS.

The award was presented by All Indian Origin Chemists & Distributors (AIOCD) AWACS. AWACS is a market research agency with syndicated audit Pharma Trac. These awards are instituted to recognise and reward top performers of the domestic pharma industry. This was the first edition of such awards, by an independent market research agency in India.

ERLONAT was introduced by NATCO as the first generic Erlotinib in the year 2009. It was marketed at a fractional cost of the innovator drug, which benefitted thousands of non-small cell lung cancer and pancreatic cancer patients.

On behalf of the NATCO team, Mr.K. Srivastava-Vice President (Sales and Marketing), Mr. James Rajakumar- GM (Oncology Division) & Mr. Lalon Sen-Product Manager (Lung Cancer Portfolio) received the award on 7th October 2015 at Nehru Centre, Worli, Mumbai.


NATCO PHARMA LIMITED, WINNER OF ‘ GOLDEN PEACOCK INNOVATION MANAGEMENT AWARD’ FOR THE YEAR 2015 12 October 2015

NATCO PHARMA LIMITED, WINNER OF ‘ GOLDEN PEACOCK INNOVATION MANAGEMENT  AWARD’ FOR THE YEAR 2015

Natco Pharma Limited was declared as the Winner of ‘Golden Peacock Innovation Management Award’  for the year 2015, by the Awards Jury of Golden Peacock Awards Chaired by Justice M.N.Venkatachaliah, former Chief Justice, Supreme Court of India.

The award was presented at a specially organized event by the Institute of Directors (IOD), India, “Global Peacock Awards Nite” held on 8thOctober 2015 at Millennium Hotel, London Mayfair. This occasion  was  graced  by  distinguished gathering of business leaders attending the IOD India’s 15th London Global Convention wherein conference on “Corporate Governance & Sustainability” and “Global Business Meet” were held during 7 – 9 October, 2015 in London (UK).

Dr.A.K.S. Bhujanga Rao, Director and President (R&D and Tech.) and CS M. Adinarayana, Company Secretary & Vice President (Legal & Corp. Affairs) attended the event and received the award on behalf of the Company from the hands of the Rt. Hon Oliver Letwin MP, The Chancellor of the Duchy of Lancaster and Hon’ble Cabinet Minister of United Kingdom.


Natco Closes QIP 15 September 2015

Natco Closes QIP

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Natco Announces QIP Issue 10 September 2015

Natco Announces QIP Issue

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NATCO receives FIPB approval for Qualified Institutional Placement for up to Rs.450 crores and Foreign Investment limit increase to 31.5% 13 August 2015

NATCO receives FIPB approval for Qualified Institutional Placement for up to Rs.450 crores and Foreign Investment limit increase to 31.5%

Hyderabad based NATCO Pharma Limited informed that Foreign Investment Promotion Board (FIPB) has approved both of its Foreign Direct Investment (FDI) related proposals in its 221st Meeting held on July 13th, 2015.

The two approvals given are for:-

  • Increase of Foreign Investment Limit from 24% to 31.5% of the paid up equity share capital of the company.
  • Issue and Allotment of Eligible Securities to Qualified Institutional Buyers (QIBs) up to Rs.450 crores.

NATCO Stock Split - Records Rs.225.54 crores revenue for the First Quarter, ended June 2015 12 August 2015

NATCO Stock Split - Records Rs.225.54 crores revenue for the First Quarter, ended June 2015

Board of Directors of Hyderabad based NATCO Pharma Limited approved and recommended to the members of the company a Sub-division of face value of its equity shares from Rs.10/-(rupees ten only) each to that of Rs.2/-(rupees two only) each. It also announced an aggregate consolidated net revenues of Rs.225.54 Crores for the quarter ended on 30th June, 2015, as against Rs.211.48 Crores during the same quarter last year thus recording an increase of about 6.6%.

The net profit, after tax, on a consolidated basis, was Rs.28.23 Crores, as against Rs.33.46 Crores for the same quarter last year. Although this is a decrease of about 15.6% compared to the same quarter last year, the company expects strong sales growth with high-margin products, in the ensuing quarters of FY2016.


IDFC Securities invites you to the Q1 FY16 Earnings call of NATCO Pharma Limited 08 August 2015

IDFC Securities invites you to the  Q1 FY16 Earnings call of NATCO Pharma Limited

Click here to view Invitation.


U.S.Court of Appeals for the Federal Circuit Finds Teva’s 808 COPAXONE Patent Invalid 19 June 2015

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that U.S Court of Appeals for Federal Circuit has again found Teva’s US Patent No.5.800.808 (“the 808 patent”) for Copaxone to be invalid as indefinite. The Company awaits USFDA approval to launch the Product.


EGM notice for the members of Natco Pharma Limited will be held on Saturday, the 27th June, 2015. Click for more info 04 June 2015

EGM notice for the members of Natco Pharma Limited will be held on Saturday, the 27th June, 2015. Click for more info

Notice is hereby given that an Extraordinary General Meeting of the Members of Natco Pharma Limited will be held at at Jubilee Hills International Centre, Road No.14, Jubilee Hills, Hyderabad 500033 on Saturday, the 27th June, 2015 at 10.30 a.m.

Click her for a PDF with more information


NATCO records Rs.840 crores net revenues for the year ended March 2015 25 May 2015

NATCO records Rs.840 crores net revenues for the year ended March 2015

The Board of Natco Pharma Limited (NPL) met in Hyderabad today and adopted the consolidated audited accounts of the company for the year ended 31st March, 2015.

NPL recorded an aggregate of Rs.840.18 crores in consolidated net revenues for the year ended on 31st March, 2015, as against Rs.755.60 crores for last year, reflecting a growth of 11.20%.

The net profit, after tax, on a consolidated basis, was recorded as Rs.134.61 crores. This includes two exceptional items:

(a) A decrease in profit on account of an extraordinary charge of Rs.15.13 crores due to a legal settlement.

(b) An increase in profit on account of a reversal of deferred tax liability of Rs.31.17 crores for the quarter ended March 31st, 2015, the Company recorded a net revenue of Rs.204 crores, on a consolidated basis, as against Rs.193.76 crores during Q4, FY 2014, posting an increase of 5.28%, quarter-on-quarter basis. The profits, after tax, on a consolidated basis, was recorded as Rs.54.44 crores, which includes a deferred tax reversal.


NATCO RECEIVES GENERIC SOFOSBUVIR (SOVALDI®) APPROVAL FOR INDIA 11 March 2015

NATCO RECEIVES GENERIC SOFOSBUVIR (SOVALDI®) APPROVAL FOR INDIA

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that it is the 1st company in India to get approval for generic sofosbuvir tablets, 400mg, from Drugs Controller General (India).  Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc.,under its brand Sovaldi®.

Natco will market generic sofosbuvir under its brand HEPCINAT and through strategic partners in India. Natco plans to price its generic medicine at an MRP of INR 19,900 for a bottle of 28 tablets and expects to launch in India very soon. Natco had recently signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries.


NATCO launches HEPCINAT in Nepal- 1 st generic version of Sofosbuvir (Sovaldi®) in the country 09 March 2015

NATCO launches HEPCINAT in Nepal- 1 st generic version of Sofosbuvir (Sovaldi®) in the country

NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched the first generic version of sofosbuvir in Nepal. Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi®. Natco priced its generic medicine at an MRP of INR 19,900 for a bottle of 28 tablets in Nepal.

NATCO markets generic sofosbuvir under its brand HEPCINAT. Natco hopes to launch HEPCINAT in India soon, subject to approval from the Drugs Controller General of India (DCGI). Natco had recently signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries.


Supreme Court Agrees With NATCO and denies Petition For Certiorari On Generic TAMIFLU Patent 09 March 2015

Supreme Court Agrees With NATCO and denies Petition For Certiorari On Generic TAMIFLU Patent

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is pleased with the U.S.Supreme Court’s decision to deny certiorari for the generic version of Tamiflu® oral capsules (oseltamivirphosphate). Natco is partnered with Alvogen in the USA for marketing of this product. The denial was issued on March 9, 2015, in the case of Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al, No. 14-647.

Natco has already received a tentative approval on March 14, 2014, for Oseltamivir Phosphate Capsules USP,30 mg (base), 45 mg (base) and 75 mg (base) on the Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the United States Food & Drug Administration (USFDA).

In the April 22, 2014 Federal Circuit decision, Circuit Judges Chen and Prost agreed with Natco and Alvogen’s position that an earlier filed and earlier expiring patent qualifies as an obviousness-type double patenting reference for a later filed, and later expiring patent. The Supreme Court today declined to review the Federal Circuit’s decision. The case remains pending in the District of New Jersey where the validity of U.S. Patent  No. 5,763,483 continues to be challenged.


NATCO announces Licensing Agreement with Gilead Sciences 02 March 2015

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has signed a nonexclusive
licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic
hepatitis C medicines. The medicines include sofosbuvir, ledipasvir/sofosbuvir and the investigational NS5A
inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that
combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C.
This agreement allows Natco to expand access to these chronic hepatitis C medicines in 91 developing
countries. Under the license, Natco can set its own price for the generic products it produces, paying a
royalty on sales to Gilead to support product registrations, medical education and training, safety
monitoring and other essential business activities.


NATCO announces USFDA Filing for Sorafenib Tablets, 200mg 11 February 2015

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that its marketing partner, Mylan Inc. (Nasdaq:MYL), has filed an Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the U.S. Federal Drug Administration (USFDA). This product is the generic version of NEXAVAR®, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

Natco and its marketing partner believe that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.

Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR®, in the USA market. For the 12 months ending Dec. 31, 2014, NEXAVAR® had U.S. sales of approximately $48 million, according to IMS Health.

@The trademark is the property of the respective Owner.


NATCO records Rs.202.80 crores revenue for the Third Quarter, ended December 2014 11 February 2015

Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.202.80 Crores in consolidated net revenues for the quarter ended on 31st December, 2014, as against Rs.204.63 Crores during the same quarter last year, recording a slight decrease of about 1%. The net profit, after tax, on a consolidated basis, before exceptional item was Rs.29.47 Crores, as against Rs.29.88 Crores same quarter last year.

There was a one-time exceptional charge of Rs.15.13 crores for settlement of a legal case during Q3. As a result, the net profit, after tax, on a consolidated basis, was Rs.14.34 Crores.


NATCO announces USFDA Filings for Fingolimod, 0.5mg Capsules and Cabazitaxel 60mg/1.5ml Injection 09 February 2015

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, with the U.S. Federal Drug Administration (USFDA), through its respective marketing partners in the USA.

Natco & its associated marketing partners for the above products in the USA, believe that they are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, providing 180 days of marketing exclusivity upon its final USFDA approval.

Novartis sells Fingolimod 0.5mg Capsules under Brand name Gilenya®, in the USA market and used for the treatment of certain patients with multiple sclerosis. The market size of Gilenya® in the USA is approximately US$1.2 Billion for twelve months ending September 2014, according to IMS Health.

Sanofi sells Cabazitaxel 60mg/1.5ml Injection under Brand name Jevtana®, in the USA market and used for the treatment of certain patients with hormone-refractory prostate cancer. The market size of Jevtana® in the USA is approximately US$116.8 Million for twelve months ending September 2014,according to IMS Health.

All trademarks are the property of their respective owners.


2014


SLP filed by Bayer against Natco has been dismissed by Hon'ble Supreme Court of India 12 December 2014

Natco Pharma Ltd. wishes to announce that the Special Leave Petition (SLP) preferred by Bayer Corporation against the order of Bombay High Court dt.15th July, 2014 confirming the Compulsory License (CL) grant to Natco Pharma Ltd. has been dismissed today by the Hon’ble Supreme Court of India. The said SLP was filed by Bayer against Union of India, Natco Pharma Ltd. and Others for the grant of CL to Natco for Bayer’s product Sorafenib (which is used for liver and kidney cancer).


NATCO records Rs.32.37 crores profit for the Second Quarter, ended September 2014 12 November 2014

Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.222.42 Crores in consolidated net revenues for the quater ended on 30th September, 2014, as against Rs.181.20 Crores during the same quater last yeat, recording an increase of about 23%. The net profit, after tax, on a consolidated basis, improved to Rs.32.37 Crores, as against Rs.26.92 Crores same quater reflecting a 20% increase.


Intimation 22 October 2014

Click here to view Intimation


NATCO announces USFDA Tentative Approval for Armodafinil 50mg, 150mg, and 250mg Tablets 21 October 2014

Natco Pharma Limited (NSE: NATCOPHARM , BSE: 524816) announced today that its marketing partner in the USA, Breckenridge Pharmaceutical,Inc., has received a tentative approval from the United States Food & Drug Administration (USFDA) for Armodafinil 50mg, 150mg, and 250mg Tablets.

Breckenridge filed the Abbreviated New Drug Application (ANDA) with a Paragraph IV certification to obtain approval to engage in the commercial manufacture,use and sale of its generic to Nuvigil® prior to expiration of the listed patents. Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon, the terms of which are confidential. Cephalon has granted Natco and Breckenridge a license to market generic versions of the 50mg,100 mg, 150mg, 200 mg and 250mg strengths of Nuvigil®, beginning 180-days after the initial launch of these strengths .

Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg Tablets under Brand name Nuvigil® in the USA market. Nuvigil® is a wakefulness promoting agent for oral administration . The market size of Nuvigil® in the USA is approximately US $457 Million for twelve months ending August 2014,according to IMS Health.

All trademarks are the property of their respective owners.


Natco’s Kothur Formulation Facility found acceptable by USFDA 18 September 2014

Natco’s Kothur Formulation Facility found acceptable by USFDA Natco has received a letter dated July 14th 2014 after completing review of the Establishment Inspection Report (EIR) for the inspection conducted from May 19th to 23rd, 2014.

The Facility was classified as acceptable. The Company has made proposed commitments and corrective actions based on the minor and routine observations during inspection. We continue to manufacture and sell products in the US. We strongly deny all adverse speculations against the Company.


Breckenridge/NATCO files ANDA for Everolimus, 0.25mg, 0.5mg, and 0.75mg Tablets 05 September 2014

Natco Pharma Limited (NSE: NATCOPHARM) announced today that its marketing partner in the USA, Breckenridge Pharmaceutical, Inc. (BPI), has filed an Abbreviated New Drug Application (ANDA) for Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets.

Natco and BPI believe that its Paragraph IV ANDA was filed on the First-to-File date and expects to be the only generic that is entitled to the 180-day exclusivity period.

Novartis AG sells Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets under Brand name Zortress® in the USA market. Zortress® is used to prevent organ rejection after a kidney or liver transplant. Zortress® generated sales of $43.5 million for the twelve-month period ending July 2014, based on industry sales data.

Zortress® is a trademark of Novartis AG or its affiliates.


NATCO's marketing partner, Mylan Inc., files ANDA For Three Times Per Week Generic Copaxone® 40 mg/mL 30 August 2014

Natco Pharma Limited (NSE: NATCOPHARM) announced today that its marketing partner in the USA, Mylan Inc. (Nasdaq: MYL), has filed an Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE® (glatiramer acetate injection, 40 mg/mL) and has been accepted by the U.S. Food and Drug Administration (US FDA).COPAXONE® is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Natco’s partner Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.

In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva.Copaxone 40 mg/mL had U.S. sales of approximately $411.5 million for the 12 months ending June 30, 2014, according to IMS Health.


NATCO records Rs.33.46 crores profit for the First Quarter ended June 2014 13 August 2014

NATCO records Rs.33.46 crores profit for the First Quarter ended June 2014.

Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.211.48 Crores in consolidated net revenues for the quarter ended on 30th June, 2014, as against Rs. 176.01 Crores during the same quarter last year, recording an increase of about 20%. The net profit, after tax, on a consolidated basis, improved to Rs. 33.46 Crores, as against Rs. 21.78 Crores same quarter last year reflecting a 54% jump.


Natco pleased with Bombay High Court decision to uphold Compulsory License on Nexavar issued to the Company 15 June 2014

Natco is pleased to inform that the Bombay High Court upheld the compulsory license (CL) granted to the Company on Nexavar (sorafenib tosylate) of German drug Major Bayer’s patented kidney cancer drug.

The Nexavar issue dates back to March 9, 2012, when the then Controller General of Patents issued the first-ever CL to the Company to manufacture an affordable generic version of sorafenib tosylate, the anti-cancer drug for which Bayer had obtained a patent.


NATCO records Rs.103 crores profit for the year ended March 2014 30 May 2014

NATCO records Rs.103 crores profit for the year ended March 2014

The Board of NATCO Pharma met at Hyderabad today and adopted the consolidated audited accounts of the company for the year ended 31st March, 2014.

The Company had posted a 13% increases in its gross revenues at Rs.200 Crores for the quarter ended 31st March, 2014, as against Rs.176 Crores for the same quarter last year. The net profit after tax for the quarter ended 31st March, 2014 was Rs.24.02 Crores (as against Rs.11.32 Crores last year).

The Company had posted a 11% increase in its gross revenues at Rs.781 Crores for the year ended 31st March, 2014 – as against Rs.705 Crores during the last year. The Company had earned a profit after tax of Rs.103 Crores against Rs.72 Crores last year.

The turnover and the profit growth was driven by strong performance on account of export of Finished Dosage formulations to North America & South America in addition to growth in the domestic Oncology products division by 17%.


Breckenridge/NATCO files ANDA For Bendamustine Hydrochloride powder 28 April 2014

Natco Pharma Limited (NSE: NATCOPHARM) announced today that its marketing partner in the USA, Breckenridge Pharmaceutical, Inc., has filed an Abbreviated New Drug Application (ANDA) for Bendamustine Hydrochloride powder; IV infusion (25mg/vial and 100mg/vial).

Breckenridge’s ANDA includes a paragraph IV certification to obtain approval to engage in the commercial manufacture, use or sale of the drug before expiration of the ‘190, ‘524, and ‘863 patents. Natco and Breckenridge believe that the ANDA was filed on the first-to-file date, providing 180 days of exclusivity.

Teva (Cephalon) sells Bendamustine Hydrochloride under Brand name TREANDA, used as a chemotherapy medicine in oncology segment. The market size of Bendamustine Hydrochloride in the USA is approximately US$660M for twelve months ending September 2013, according to IMS Health.


NATCO Pharma pleased with Federal Circuit’s decision on Oseltamivir 24 April 2014

Natco Pharma Limited and Alvogen, who have partnered with respect to the first substantially complete Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA) for the generic version of Tamiflu® oral capsules (oseltamivir phosphate), are pleased with the Federal Circuit’s decision of April 22nd in the case of Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al, 2013-1418.

In it, Circuit Judges Chen and Prost agreed with Natco and Alvogen that the earlier expiring Orange Book listed patent qualifies as an obviousness-type double patenting reference for the later expiring Orange Book listed patent. The case has been remanded to the District court of New Jersey where Natco and Alvogen will continue to challenge the validity of U.S. Patent No. 5,763,483.Natco may have First to File approval status for the Abbreviated New Drug Application (ANDA), contingent upon successful litigation outcome.

TAMIFLU® (Roche’s trade name for Oseltamivir Phosphate) had U.S. sales of approximately $495 Million for twelve months ending September 2013, according to IMS Health.


Supreme Court Chief Justice denies Teva's Request for an Injunction Relating to Generic Copaxone®; Clears Legal Hurdle for Mylan & Natco to Launch the same at Market Formation 21 April 2014

NATCO today announced that Supreme Court Chief Justice Roberts has denied Teva’s application for an injunction seeking to prevent launch of a generic version of Copaxone@reg; pending the Supreme Court’s decision on Teva’s appeal. This is the second time that the Chief Justice has denied Teva’s request for such an injunction.


Natco clarifies in response to speculation about Generic Copaxone 03 April 2014

Natco today issues a clarification with regard to launch of generic Copaxone. There has been recent speculation as to the role of Natco in the future decision(s) related to potential launch and/ or pricing of generic Copaxone in the United States. Natco confirms the final decision as to when or whether and pricing of generic Copaxone is launched in the US rests with its Partner Mylan. Natco remains committed and working to take steps and deploy the necessary resources to ensure that a quality generic US FDA approved Copaxone is made available to patients suffering from Multiple Sclerosis upon market formation. The Stock Exchange will be duly informed whenever such a decision is made in the future.


NATCO comments on Copaxone patent 01 April 2014

NATCO Pharma ltd. today informs the exchange that the US Supreme Court agreed to hear appeal in a patent fight on Copaxone. The company continues to believe that Teva’s ‘808 patent is invalid for indefiniteness.


NATCO Comments on Decision by New Delhi High Court Against Teva 01 March 2014

Natco Pharma Ltd. today commented on the New Delhi High Court’s decision to dismiss a lawsuit related to applications filed by Teva Pharmaceuticals Industries Ltd., Yeda Research and Development Co. Ltd. and Teva API India Limited (“Teva”). Teva had alleged that Natco’s use in India of the well-known process to manufacture copolymer-1 infringes Yeda’s Indian Patent No. 190759(“IN’759”).

Natco commented, “We are very pleased with the decision by the New Delhi High Court to dismiss and take no action in this matter. We continue to believe that the sole Indian process patent is invalid, as reinforced by the outcomes of numerous other legal proceedings. We also are pursuing other challenges against this patent.”

In addition to defending against Teva’s actions in the New Delhi High Court, the company is pursuing other challenges against the IN’759 patent, including a petition to the New Delhi High Court to invalidate the patent. The hearing on this petition has been set for 5 March 2014. Further, the Indian Patent Office refused to grant two additional patent applications, which would have covered the copolymer-1 product.

The U.S. counterpart to the IN’759 patent, U.S. Patent No. 5,800,808, along with four other U.S. patents, was held to be invalid by the U.S. Court of Appeals for the Federal Circuit last July. All of Teva’s further appellate attempts have been unsuccessful to date.


NATCO exhibits improved results, recommends Rs. 5 interim 14 February 2014

Hyderabad based NATCO Pharma Limited had exhibited improved operating results for the quarter ended 31st December, 2013.

Aggregate revenues went up to Rs. 181.70 Crores (from Rs. 163.38 Crores during the same quarter last year), while the profit after tax went up to Rs. 32.42 Crores (from Rs. 24.37 Crores during the same quarter last year).

On a consolidated basis, the revenues for the quarter went up to Rs. 211.05 Crores (from Rs. 190.91 Crores during the same quarter last year), while the profit after tax went up to Rs. 29.88Crores (from Rs. 22.59 Crores during the same quarter last year).

Rs. Lakhs
Particulars For the quater ended 31-12-2013 For the quater ended 31-12-2012
Stand-alone gross revenues 18170 16338
Stand-alone profit after tax 3242 2437
Consolidated gross revenues 21105 19091
Consolidated profit after tax 2988 2259

The Board has recommended payment of an interim dividend of Rs. 5 per share, payable on 6th March, 2014.


2013


NATCO records higher profits 14 November 2013

Hyderabad based NATCO Pharma Limited has recorded higher profits for the quarter ended 30th September, 2013.

For the quarter ended 30th September, 2013, on a consolidated revenue base of Rs. 188 Crores, the company earned a net profit after tax, of Rs. 27 Crores as against Rs. 21 Crores on a revenue base of Rs. 191 Crores last year.

The EBIDTA margins have expanded to 31% of the revenues, from 26% last year. The growth has been driven by value-added formulation exports during the quarter.


Natco EGM Notice 24 October 2013

Click here to view EGM Notification


NATCO turns out better performance 14 August 2013

Hyderabad based NATCO Pharma Limited has clocked an aggregate of Rs.182 Crores in consolidated

Revenues for the quarter ended on 30th June, 2013, as against Rs. 151 Crores during the same quarter last year, recording an increase of around 21%. The net profit, after tax, on a consolidated basis, improved to Rs.2178 lakhs, as against Rs. 1707 lakhs same quarter last year. This amounts to an increase of around 28%.

On a stand-alone basis, the revenues improved by 23% (Rs. 154 Crores as against Rs. 125 Crores), while the net profit after tax, improved by 25% (Rs. 2274 lakhs as against 1818 lakhs).

API exports and finished dosage pharmaceutical formulations exports continue to drive the growth.

With a favorable verdict having been received from the Federal Circuit Court, the Company is awaiting US FDA approval of its ANDA for Glatiramer Acetate (Copaxone®) for a possible launch in May 2014 in association with Mylan Inc.


NATCO obtains a favorable ruling on Copaxone® 27 July 2013

NATCO Pharma Limited is pleased to announce the US Court of Appeals for the Federal Circuit ruling, reversing a district court’s finding related to Teva’s US Patent for Copaxone®.

This would essentially mean that NATCO could launch the generic Copaxone – through its marketing partner – Mylan Inc., during May 2014, subject to FDA approval.

Copaxone® (Glatiramer Acetate) is used in the treatment of relapsing-remitting multiple sclerosis.

The product is estimated to have clocked revenues, in USA, of about US $ 3.45 Billion during 2012.


NATCO announces marketing approval for Rizatriptan (ODT), commences shipments 03 July 2013

NATCO Pharma Limited is pleased to announce the receipt of marketing approval for its Rizatriptan Benzoate (Maxalt-MLD) – orally disintegrating tablets, 5 mg and 10 mg (base). The Company has already commenced shipments of the product, which is being launched by its marketing partner – Breckenridge Pharmaceuticals. Rizatriptan is used to treat migraine headaches with or without aura (warning signs that occur prior to the onset of a migraine headache).

NATCO estimates the market to be around US $ 250 Million (before generic launch – as of December, 2012).


NATCO posts higher revenues, profits !!! 30 May 2013

The Board of NATCO Pharma met at Hyderabad today to adopt the stand-alone audited accounts of the company for the year ended 31st March, 2013.

The Company had posted a 14% increases in its net revenues at Rs. 143 Crores for the quarter ended 31st March, 2013, as against Rs. 126 Crores for the same quarter last year. The net profit after tax for the quarter ended 31st March, 2013 was 11.72 Crores (as against Rs. 14.53 Crores last year). The profit would have been higher, but for an additional non-cash deferred tax liability of Rs. 7 Crores during the quarter, due to increased capital expenditure.

The Company had, however, posted a 28% increase in its net revenues at Rs. 559 Crores for the year ended 31st March, 2013 – as against Rs. 435 Crores during the last year. The Company had earned a profit after tax of Rs. 78 Crores against Rs. 62 Crores last year.

The strong performance was driven by a 51% growth in the revenues from the active pharmaceutical ingredients segment (Rs. 223 Crores as againt Rs. 148 Crores last year), and a 58% increase in revenues from the finished dosage pharmaceutical formulation exports (Rs. 103 Crores as against Rs. 65 Crores last year). The company expects to grow at 15% – 20% this financial year.


NATCO Pharma records improved results, declares 40% interim 13 February 2013

Hyderabad based NATCO Pharma Limited has recorded improved operating results for the quarter and nine-months ended on 31st December, 2012.

The Board has also recommended payment of an interim dividend of Rs.4 per equity share, payable on 6th March, 2013

The following are the highlights of the consolidated operational performance.

Rs.Lakhs
Quarter Ended On Nine Months Ended On
31-Dec-2012 31-Dec-2011 31-Dec-2012 31-Dec-2011
Gross Revenues 19091 14578 53240 40450
Profit Before Tax 3320 2204 8377 6185
Profit After Tax 2259 1700 6054 4696
Increases in Revenues (YOY) 31% 32%
Increase in PAT 33% 29%

The increase in revenues was driven by API and formulation exports. Out of the total revenues for the nine months period ended on 31st December, 2012, exports accounted for 47% at Rs. 213 Crores.


2012


NATCO receives USFDA approval, all set to launch Lansoprazole 19 December 2012

NATCO Pharma Limited is pleased to announce the approval by US FDA, of its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed Release Capsules, USP, 15 mg and 30 mg. for the prescription market.

Shipments of this product will commence immediately.


NATCO reports improved performance 08 November 2012

The Board of Directors of the Hyderabad based NATCO Pharma Limited, met today and took on record the operational performance of the Company for the quarter and half-year ended on 30th September, 2012.

The Company has recorded a consolidated revenue base of Rs. 191 Crores for the quarter ended on 30th September, 2012 (up by 26% on a sequential basis and by 41% on a year-on-year basis). The profit after tax at Rs. 21 Crores also grew by 24% on a sequential basis and by 31% on a year-on-year basis.

The growth in revenues and profitability was driven by increased sales of APIs and exports of finished dosage pharmaceutical formulations.

For the half-year ended on 30th September, 2012, the consolidated revenues stood at Rs. 341 Crores, recording an increase of 32% as compared to the half-year ended on 30th September, 2011. The profit after tax for the half year stood at Rs. 38 Crores as compared to Rs. 30 Crores for the half-year ended on 30th September, 2011, recording an increase of 27%.

Exports, at Rs. 85 Crores, constituted 52% of the revenues of the Company for the quarter ended on 30th September, 2012. At Rs. 127 Crores, they constituted 44% of the revenues for the half year ended on 30th September, 2012.


Rajeev takes over as Vice Chairman & Chief Executive Officer 21 June 2012

NATCO Pharma Limited, Hyderabad, is pleased to announce the elevation of Mr.Rajeev Nannapaneni to the position of Vice Chairman & Chief Executive Officer.

Rajeev, who joined the Board in 2005, was till now the Chief Operating Officer.

Thirty five year old Rajeev has many accomplishments to his credit. Rajeev completed B.A. Honors (Double Major in Economics and History) from Tufts University, Boston, U.S.A., and after a short stint with Merrill Lynch, USA, as a Financial Analyst, joined the company in 2000. Rajeev has been instrumental in helping the company evolve business strategies that ultimately resulted in NATCO becoming one of the fastest growing companies in the Indian Pharma space. Taking forward the company’s mission of making available life saving medicines at an affordable cost, Rajeev ensured that the Company got on to the Oncology bandwagon in 2003, far ahead of competition and also achieved the enviable record of making the company far ahead of others in terms of revenues from this segment amongst the Indian companies. A champion of the “cheaper generic drugs”, Rajeev was instrumental in NATCO obtaining the first ever compulsory license in India for the generic version of Bayer’s Nexavar – a drug used in the treatment of kidney and liver cancers.

Particular mention must be made of NATCO’s ability to take on global pharmaceutical giants – often challenging their R & D capabilities and ensuring that generic drugs are available at a fraction of the innovator’s price. This strategy has paid off and today NATCO has several para IV and firstto-file opportunities ready and the company is in a position to encash multi-Billion marketing opportunities.

Rajeev would be incharge of all day-to-day operations of the Company and would oversee all functional areas.


NATCO records increased revenues, profits!!! 28 May 2012

The Hyderabad based NATCO Pharma Limited has recorded increased revenues and profits for the financial year ended on 31st March, 2012. The Board met at Hyderabad today and approved the accounts.

The Company has recorded aggregate revenues of Rs. 559 Crores (an increase of 15% over 2011- Rs. 484 Crores) and earned an after tax profit of Rs. 60 Crores (an increase of 12% over 2011 – Rs. 53 Crores).

The growth was driven by a 40% increase in API sales at Rs. 148 Crores from Rs. 106 Crores during 2011, a 22% increase in Formulation sales at Rs. 282 Crores in 2012 from 232 Crores in 2011. The company’s oncology division performed well, recording an increase in sales from Rs. 121 Crores in 2011 to Rs. 148 Crores in 2012. The company’s exports aggregated to Rs. 183 Crores, an increase of 37% over that of 2011 (Rs. 134 Crores).


Natco bagged Golden Peacock Award 2012 27 April 2012

Natco bagged Golden Peacock Award 2012

Natco Pharma Limited has been selected as the National Award winner of the ‘Golden Peacock Award for Corporate Social Responsibility’ for the year 2012 by the awards Jury under the Chairmanship of Justice P.N.Bhagwati, former Chief Justice of India and Member, UN Human Rights Commission.

The award was presented at a specially organized “Awards Gala Nite” on Wednesday, 25 April 2012 in Dubai in the presence of distinguished gathering of business leaders, jurists, academics, environmentalists, economists, legislators and policy makers during the Dubai Global Convention incorporating the 7th International Conference on Social Responsibility, which was held on 24 – 26 April 2012 in Dubai.

Natco Pharma Limited is the first Indian Pharma Company which received the award from His excellency Dr.Abdulrahman A., Al-Alwar, Director-General, Federal Authority for Government Human Resources (FAHR) in the august presence of Justice M.N.Venkatachaliah, Former Chief Justice of India, His excellency Mr.Juma Al Majid, Chairman of Dubai Economic Council & Founder Chairman of Juma Al Majid Group also present. Natco Pharma Limited has bagged the award under stiff competition which shows and proves its commitment to the Corporate Social Responsibility.


NATCO granted compulsory licence for Nexavar 12 March 2012

The Hyderabad based NATCO Pharma Limited is pleased to announce the granting of a compulsory licence to it, under the provisions of Section 84 of the Indian Patents Act, 1970 for Sorafenib Tosylate (Brand Name : Nexavar owned by Bayer Corporation). Nexavar is the first-line treatment for liver and kidney cancer.

The Compulsory License, first of its kind granted, enables NATCO to sell the drug at a price not exceeding Rs. 8880 for a pack of 120 tablets (one month’s therapy) against Rs. 284,428 being the cost of Naxavar sold by Bayer. The license is valid till the expiry of the patent – 2021.

The order is subject to certain conditions such as maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis etc. The order also makes it obligatory for NATCO to supply the drug free of cost to at least 600 needy and deserving patients per year.

NATCO welcomes this order and opines that this opens up a new avenue of availability of life savings drugs at an affordable price to the suffering masses in India.


NATCO declares interim dividend; Sales, Profits up !!! 09 February 2012

Hyderabad based NATCO Pharma Limited has posted an aggregate revenues of Rs. 405 Crores for the nine month period ended on 31st December, 2011, an increase of 10% over that recorded for the nine month period ended on 31st December, 2010. The company posted a net profit, after tax, of Rs. 47 Crores (Rs. 39 Crores for 2010) for the nine month period ended on 31st December

The revenues for the quarter ended on 31st December, 2011 stand at Rs. 145 Crores as compared to Rs. 133 Crores for the three months ended on 30th September, 2011. The net profit after tax, for the same period stand at Rs. 1700 lakhs as compared to Rs. 1594 lakhs.

The growth was driven by increased API sales and formulation exports.

The Board had recommended the payment of an interim dividend of Rs. 3/- per share. (2010- Rs. 2/- per share).


2011


NATCO records increased turnover,profitability 09 November 2011

The Hyderabad based NATCO Pharma Limited has recorded increased turnover and profitability for the quarter and half-year ended on 30th September, 2011.

The stand-alone revenues, for the quarter ended on 30th September, 2011 grew (from Rs. 9455 lakhs) to Rs. 11449 lakhs, on a year-on-year basis, recording an increase of 21%. The net profit after tax, for the same period, grew (from Rs. 1472 lakhs) to Rs. 1603 lakhs, recording an increase of 9%.

For the half year ended on 30th September, 2011, the revenues recorded an increase of 18% from Rs. 18497 lakhs as at 30th September, 2010 to Rs. 21740 lakhs as at 30th September, 2011. The net profit, after tax, for the same period grew (from Rs. 2516 lakhs) to Rs. 2980 lakhs, recording an increase of 18%.

The growth was driven by revenues from API division, (from Rs. 50 Crores to Rs. 77 Crores) on a year-on-year basis for the half-year ended on 30th September, 2010 and 2011.


NATCO to enter bio-generics (mAbs), signs up with Mabxience 19 October 2011

Hyderabad based NATCO Pharma Limited has entered into an exclusive agreement with Mabxience, the bio-similar division of Chemo Sa Lugano, Switzerland, an integrated healthcare multinational involved into different fields of pharmaceutical business, including bio-similars and branded pharmaceuticals.

Under the agreement, NATCO will purchase four mAb drug substances from Chemo and use the same for manufacturing finished dosage pharmaceutical formulations. Three of these products viz., Trastuzumab, Bevacizumab, Rituximab belong to the oncology segment, while Etanercept is for auto-immune disease. NATCO’s obligations under the agreement will include manufacture of drug products, undertake local clinical trials, filing registration of dossiers, to apply for market authorizations and to commercialize the product in India and a few other Asian countries.

Oncology is the largest therapy area within the mAb market, with eight marketed products. The mAb market is highly innovative and a key trend has been the move from murine to humanized and fully human antibodies, with insignificant generic presence.

World-wide, the market for mAbs has grown rapidly and is currently at a revenue level of around US $ 35 Billion.

With the product combinations chosen by NATCO, the mAb initiative is likely to be completed in a period of 24 to 36 months.


NACTO Records Higher Profits 12 August 2011

Hyderabad based NATCO Pharma Limited had recorded increased profits for the first quarter (April 2011 – June 2011) of the current fiscal 2011-12.

The consolidated revenues for the quarter ended 30th June, 2011 stood at Rs 123 Crores and would have been higher, but for the sale of one of the retail pharmacy stores in the USA. However, the profit after tax grew by over 32% – from Rs.1059 Lakhs (same quarter last year) to Rs.1403 Lakhs (current year).

The Company recorded an earnings per share of Rs.4.98 (non-annualized basis).

During the current quarter, the company had filed an ANDA for Lapatinib Ditosylate 250mg tablets. The company believes that it has a first -to-file opportunity for this product. The sales of this product amounted to over US $ 114 Million last year. The company has tied-up with Lupin Limited for supply and marketing of this product.

With this product, the Company has five para IV challenges, out of which four products are with a first-to-file opportunity.


NATCO launches Anastrazole in the USA 29 June 2011

NATCO Pharma Limited is pleased to announce the launch, in the United States of America, of the generic version of Anastrazole 1 mg. tablets, consequent to the final approval received from the US FDA.

The product has been launched through the company’s marketing partners.

The company recorded an EPS of Rs. 17.31 on a consolidated basis for the year 2010, as against Rs. 15.62 last year.

Anastrazole is used in the treatment of breast cancers and the market for this product in the USA is expected to be in the region of US $ 750 Million per annum. The company is confident of gaining a reasonable share of the market.


NATCO launches BENDIT 07 April 2011

Hyderabad based NATCO Pharma is pleased to announce the commercial launch of its brand – BENDIT – Bendamustine – a novel agent in the treatment of Chronic Lymphocytic Leukemia (CLL), mostly seen in the elderly people.

Bendamustine is a unique hybrid cytotoxic, which is mechanistically distinct from the existing options. Response rates to Bendamustine are reported to be high and durable, and the therapy is seen as a superior and tolerable first line option in the treatment of CLL.

Bendit is the generic version of Treanda, the innovator brand, which is priced at around Rs.86,000 per vial of 100mg. Bendit is aggressively priced at Rs.6,950 per vial of 100mg., in accordance with NATCO’S policy of making available quality medicare at an affordable price.

NATCO is exploring the possibility of introducing this product in international markets as well.


NATCO files ANDA for Oseltamivir, (Tamiflu®) ties up with Alvogen, gets First to File Status 19 February 2011

The Hyderabad based NATCO Pharma Limited is pleased to announce the acceptance of its Abbreviated New Drug Application for the generic version of Oseltamivir Phosphate capsules.

Oseltamivir Phosphate is used in the treatment of bird and swine-flu infections. Sold under the brand name Tamiflu®, the product clocked global annual sales in the region of US $ 1Billion.

NATCO has tied up with the Luxemburg based Alvogen IPCO S.a.r.l., for marketing and sales of Oseltamivir Phosphate in the USA.

NATCO is the “first applicant” to file an ANDA for the generic version of Tamiflu® and, should the ANDA be approved, may be entitled to 180 days of generic market exclusivity.


NATCO records higher earnings, higher profits 14 February 2011

The Board of the Hyderabad based NATCO Pharma Limited had recommended an interim dividend of Rs. 2 per share, payable on 10th March, 2011.

The Board, which met in Hyderabad today, considered the financial results of the Company for the quarter and nine months ended on 31st December, 2010.

The Company recorded revenues of Rs. 118 Crores for the quarter (Rs. 367 Crores for the nine -month period) ended on 31st December, 2010, as against Rs. 117 Crores and Rs. 347 Crores for the same period last year.

The company earned a net profit, after tax, of Rs. 1372 lakhs (up by 13%) for the quarter and Rs. 3913 lakhs for the nine month period ended on 31st December, 2010 as against Rs. 1214 lakhs and Rs. 3368 lakhs respectively for the same period last year. The company has accounted for a loss of nearly Rs. 300 lakhs on account of the sale of one of the retail stores in USA.


K & C Pharmacy, a general partnership firm based out of New Jersey 14 January 2011

K & C Pharmacy, a general partnership firm based out of New Jersey, USA (of which the Hyderabad based NATCO Pharma Limited is a 75% partner) has sold its right, title and interest in a retail pharmacy outlet known as Nicks’ Drugs, based in Newark, New Jersey.

Nicks’ Drugs revenues were predominantly guided by the Medicaid reimbursements from the State of New Jersey. Of-late, however, owing to budgetary restrictions, there have been significant reductions in the reimbursements. However, this sale would not have any significant effect on the revenues and profitability of NATCO Pharma Limited.

With this sale, NATCO Pharma Limited now owns and operates only one retail pharma store -through its wholly owned subsidiary – NATCOPharma Inc., – known as SaveMart Pharmacy, based in Lancaster, Pennsylvania, USA. This store is doing well and is not dependent on Medicaid reimbursements.


Press Release 09 January 2011

NATCO Pharma Limited is pleased to announce that the Government of India has stayed the suspension of its Albupax manufacturing (product) license. Albupax is a nanotechnology based drug and is the first generic version of the international brand

– Abraxane® of Abraxis Bioscience Inc., USA.

Albupax consists of Paclitaxel in an Albumin-bound nanoparticle form and is used in the treatment of breast cancer. NATCO’S manufacturing license was suspended by the Drugs Controller General of India (DCGI), allegedly for not passing the test measuring endotoxin levels.

Subsequently, NATCO appealed to the Government of India under the provisions of the Drugs & Cosmetics Rules against the suspension order. Among other things, NATCO pleaded that:

  • The testing methods used to evaluate nanotechnology based protein-bound formulations are highly complex and variable. An appropriate test method needs to be employed to test such products.
  • The product has been aggressively priced at a fraction of the innovator’s price
  • The product was received well by the medical fraternity as well as patients from various parts of India.

NATCO is thankful to the Government for its decision in this regard. NATCO stands by its commitment to provide high quality and life saving drugs at affordable price to Indian patients.

NATCO would announce its future plans shortly.