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Glenmark Pharma gets two final and one tentative ANDA approvals from US FDA
Our Bureau, Mumbai | Friday, June 24, 2016, 13:30 Hrs  [IST]

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from US FDA for Nystatin and Triamcinolone Acetonide ointment USP, 100,000 units/1 mg per gram, the generic version of Taro.

The company also received tentative approval for olmesartan medoxomil tablets, 5 mg, 20 mg and 40 mg, the generic version of Benicar tablets of Daiichi Sankyo, Inc. Glenmark will market this product upon receiving final approval.

According to IMS Health sales data for the 12 month period ending April 2016, the Nystatin and Triamcinolone Acetonide ointment USP market achieved annual sales of approximately $37.5 million and the Benicar tablet market achieved annual sales of approximately $1.05 billion.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the US marketplace and 62 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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