Glenmark Pharmaceuticals subsidiary - Glenmark Generics has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Nizatidine Capsules and will commence marketing immediately. Nizatidine capsules are Glenmark's generic version of Axid by SmithKline Beecham Corporation and are indicated for up to 8 weeks for the treatment of active duodenal ulcer.
Recently, Glenmark Generics’ United States (US) subsidiary -- Glenmark Generics Inc., (GGI) -- had been granted final approval for its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (USFDA) for Ursodiol tablets USP, their generic version of Urso 250 and Urso Forte tablets by Axcan. Ursodiol tablets are available in 250mg and 500mg strengths and are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Total market sales achieved for the Ursodiol tablets were $60 million.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. It has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.
Company Name | CMP |
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Sun Pharma Inds. | 1530.00 |
Dr. Reddys Lab | 5802.00 |
Cipla | 1399.35 |
Zydus Lifesciences | 1051.90 |
Lupin | 1653.75 |
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