Glenmark Generics Receives Approval From The USFDA For Felodipine Extended-Release Tablets

Generics Limited (GGL), recently announced they have been granted final approval from the United States Food and Drug Administration for Felodipine extended-release tablets, the generic version of Astrazeneca Pharmaceuticals LP, Plendil.

Glenmark's extended-release Felodipine tablets are available in strengths of 2.5 mg, 5 mg and 10 mg and are indicated for the treatment of hypertension. Felodopine achieved sales of USD 97 million for the 12 month period ending September 2010, according to IMS Health.

The Company will commence marketing and distribution immediately in the U.S and anticipates a successful launch based on the limited competition existing in the market.

Today's approval emphasizes Glenmark's commitment to continue introducing generic products of assorted and unique dosage types to meet the growing demand of their customers.

The Company's current portfolio consists of 63 generic products authorized for distribution in the U.S. market, as well as over 40 ANDA's filed with the U.S. FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America.

The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.

SOURCE: Glenmark Generics Limited