Glenmark Pharmaceutical receives USFDA approval

Glenmark Pharmaceutical  Limited (GPL) received final approval from United States Food & Drug Administration (USFDA) for 2.5 mg Frovatriptan Succinate tablets, the therapeutic equivalent to the reference listed drug product, 2.5 mg Frova Tablets belonging to Endo Pharmaceuticals.

According to IMS Health, which is an American company that provides information, services and technology for the healthcare industry. sales data for last 12 month period ending January 2016, the Frova market achieved annual sales of approximately USD 87.7 million (Rs 5870 million).

GPL’s current portfolio consists of 108 products authorized for distribution in the U.S. marketplace. The company has about 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. It is also identifying and exploring external development partnerships to supplement and accelerate the growth of company’s existing pipeline and portfolio.

During the month of February 2016, GPL obtained ANDA approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg. The company also bagged tentative ANDA approval for Azelaic Acid Gel -15 per cent, the generic version of Finacea Topical Gel -15 per cent, belonging to Bayer Healthcare.

The share price of GPL increased by 2.08 per cent on bourses in early trades; and is trading at Rs 831 on an intraday basis.

GPL operates across three verticals such as drug discovery, formulation business, and generic business. The company’s drug discovery is focused on the areas of inflammation, metabolic disorders and pain. Its formulations business focuses on therapeutic areas, including dermatology, anti-infective, respiratory, cardiac, diabetes, gynecology, central nervous system (CNS) and oncology. GPL's generic businesses focus on segments like dermatology, hormones, controlled substances, oncology and modified release products. The company has approximately 16 manufacturing facilities in around five countries and has around six research and development centres.