Glenmark Generics launches Trandolapril Tablets

Date: 20 June 2008

Glenmark Generics Launches Trandolapril Tablets 

June 20, 2008: Glenmark Generics Limited (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Trandolapril tablets USP 1 mg, 2 mg and 4 mg and will immediately commence marketing and distribution of these products in the U.S. market.

 Trandolapril is an ACE (Angiotensin Converting Enzyme) inhibitor used to treat high blood pressure and is the generic equivalent of Mavik® tablets marketed by Abbott Laboratories. The total sales for Trandolapril tablets in the twelve month period ending March 2008 were in excess of USD 23 million, as per IMS Health.

This recent approval coupled with the three ANDA approvals received from the U.S. FDA in May 2008 for Mometasone Cream USP 0.1%, Mometasone Ointment USP 0.1% and Metformin Tablets USP 500 mg, 850 mg, 1000 mg brings GGL’s current portfolio to 33 generic products authorized for distribution in the U.S. market. The Company currently has over 35 ANDA’s filed with the U.S. FDA pending approval.

About Glenmark Generics Ltd. (GGL) Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.  GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. GGL has a strong base in Formulations development with teams operating out of laboratories in India and Latin America. The Company has a state-of-the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world and had over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs. GGL generated USD 196 Mn in Net Sales in FY08.[www.glenmark-generics.com]  

About Glenmark Glenmark Pharmaceuticals Ltd. (Glenmark) is a research-driven, global, fully integrated pharmaceutical company headquartered at Mumbai, India. Its shares are listed on India’s two large stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5000 people across its global operations across 80 countries. The Company’s Speciality business generated USD 303 Mn in Net sales in FY08. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. The Company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211, undergoing Phase II clinical trials, has been out-licensed to Eli Lilly & company.[www.glenmarkpharma.com] 

For further information, please contact:
Ms. Shraddha Bothra
Manager, Corporate Communications
Glenmark Pharmaceuticals Ltd.
Tel : [+91 22] 4018 9919
Fax: [+91 22] 4018 9986
Email: media@glenmarkpharma.com

This document is not an offer of securities for sale in the United States or elsewhere. The shares of the Company and its subsidiaries and affiliates are not being registered under the Securities Act and may not be offered or sold in the United States unless registered under the Securities Act or pursuant to an exemption from such registration. There will be no public offering of shares in the United States. 

Download PDF