Glenmark Pharma’s US arm gets USFDA approval for Norgestimate and Ethinyl Estradiol

20 Jun 2011 Evaluate

Glenmark Generics’ (GGL) United States (US) subsidiary -- Glenmark Generics Inc., (GGI) -- has been granted final approval for its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (USFDA) for Norgestimate and Ethinyl Estradiol tablets, USP 0.18mg/ 0.035mg, 0.215mg/ 0.035mg and 0.25/ 0.035mg.

The said product is the generic version of Ortho Tri-Cyclen tablets by Ortho McNeil Janssen Pharmaceuticals Inc. indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Glenmark’s current portfolio consists of 69 products authorized for distribution in the US marketplace and 40 ANDA’s pending approval with the USFDA. 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.

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

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