Glenmark gets USFDA nod for generic anti-hypertension drug Trandolapril

Trandolapril is an ACE inhibitor used to treat high blood pressure. It acts by competitive inhibition of Angiotensin Converting Enzyme (ACE), a key enzyme in the renin-angiotensin system (RAS pathway) which plays an important role in regulating blood pressure.

It is sold by Abbott Laboratories under the name Mavik.

In the 12 months to March 2008, Trandolapril has generated sales of $23 million, according to IMS data, Glenmark said in a statement.

The abbreviated new drug application (ANDA) approval is for Trandolapril tablets USP 1 mg, 2 mg and 4 mg, the company said, adding it would begin marketing and distribution of its generic version of Trandolapril tablets in the US market.

While the USFDA has approved 33 generic products of Glenmark for distribution in the US market, there are over 35 pending ANDAs filed with the USFDA, the pharmaceutical major said.

ABOUT GLENMARK PHARMACEUTICALS LTD

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 $303 million in net sales in

FY08.

Glenmark 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 recently been out-licensed to Eli Lilly & company.