Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, has received final approval for two ANDAs viz., These approvals are for the oral contraceptive products Norethindrone and Ethinyl Estradiol (Alyacen 1/35) tablets USP, 1 mg/0.035 mg and Norethindrone and Ethinyl Estradiol (Alyacen 7/7/7) tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg and 1 mg/0.035 mg, the generic equivalents of Ortho-McNeil Janssen’s Ortho-Novum 1/35-28 tablets and Ortho-Novum 7/7/7-28 tablets, respectively.
Alyacen 1/35 and Alyacen 7/7/7 tablets are indicated for the prevention of pregnancy women who elect to use oral contraceptives as a method of contraception. According to IMS Health for the 12 month period ending September 2011, these products achieved total market sales of approximately USD 96 million.
The company’s current portfolio consists of 75 generic products authorized for distribution the US market and 41 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.