Glenmark receives ANDA approval for its contraceptive pills

Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, on Monday announced they have been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (U.S. FDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg.

Glenmark's approved product is their generic version of Ortho Cyclen® tablets by Janssen Pharmaceuticals, Inc. indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

According to IMS Health for the 12 month period ending December 2011, Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg garnered total market sales of approximately USD 88 million.

This approval marks Glenmark's tenth female hormonal product authorized for distribution by the U.S. FDA. The Company's current portfolio consists of 79 generic products authorized for distribution in the U.S. market and 39 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.