Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for its generic two oral contraceptives tablets.
The approval has been granted by the United States Food and Drug Administration (USFDA) To the company's US arm Glenmark Generics Inc, a subsidiary of Glenmark Generics Ltd, Glenmark Pharmaceuticals said in a statement.
The approvals are for the oral contraceptive products Norethindrone and Ethinyl Estradiol (Alyacen TM 1/35) tablets in different strengths.
The tablets are generic equivalents of Ortho-McNeil Janssen's 'Ortho-Novum 1/35-28' tablets and 'Ortho-Novum 7/7/7-28' tablets.
The company claimed that according to IMS Health these products achieved total market sales of nearly USD 96 million for the 12 month period ending September 2011.
Glenmark's current portfolio consists of 75 generic products authorised for distribution in the US market and 41 ANDA's filed with the USFDA pending approval.
Scrips of Glenmark Pharmaceuticals were today trading at Rs 321.40 per share in the afternoon trade on BSE, up 0.77% from its previous close.
