Glenmark Generics Inc. (GGI) the US subsidiary of Glenmark Generics Ltd (GGL), has received final approval from the US FDA 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 US and anticipates a successful launch based on the limited competition existing in the market.
The 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 US 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.