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Glenmark Pharmaceuticals’ arm gets USFDA approval for two oral contraceptives product

Glenmark Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532296 | NSE: GLENMARK

20 Jan 2012 Evaluate

Glenmark Generics Incorporation, USA, a subsidiary of Glenmark Generics, has been granted final approval for two abbreviated new drug applications (ANDA) by the United States Food and Drug Administration (USFDA).

The approvals is 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 in 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 $96 million.

With this, the company's current portfolio consists of 75 generic products authorized for distribution in the US market and 41 ANDA's filed with the USFDA pending approval.

Glenmark Generics (GGL) is a subsidiary of Glenmark Pharmaceuticals (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.

Glenmark Pharmaceuticals, a leader among the emerging market companies in drug discovery and development and most of its active substances in the pipeline are first-in-Class. Glenmark’s achievements over the year include a major deal with Sanofi in Crohn's disease, completing Phase II trials of its first novel product, crofelemer and demonstrated higher sales and profit growth.

Glenmark Pharma Share Price

2247.90 -1.65 (-0.07%)

17-Apr-2026 16:59 View Price Chart

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Glenmark Pharmaceuticals’ arm gets USFDA approval for two oral contraceptives product

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