Glenmark Generics Inc. (GGI), a US based subsidiary of Glenmark Pharmaceuticals Ltd, has received US FDA approval for norgestimate and ehinyl estradiol tablets USP, 0.25 mg and 0.035 mg. The products is 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. This approval marks Glenmark's tenth female hormonal product authorised for distribution by the US FDA.
According to IMS Health for the 12 month period ending December 2011, norgestimate and ethinyl estradiol tablets garnered total market sales of approximately US$ 88 million.
The company's current portfolio consists of 79 generic products authorised for distribution in the US market and 39 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.