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Glenmark Pharma receives US FDA tentative approval for generic Onglyza tablets

Glenmark Pharmaceuticals, USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (FDA) for saxagliptin tablets, 2.5 mg and 5 mg, the generic version of Onglyza tablets, 2.5 mg and 5 mg of AstraZeneca AB.

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Description

According to IMS Health sales data for the 12 month period ending April 2017, the Onglyza tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $518.5 million. Glenmark’s current portfolio consists of 117 products authorized for distribution in the U.S.
marketplace and 68 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.

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017).

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