Zydus Lifesciences Ltd.

BSE: 532321 | NSE: ZYDUSLIFE
Mid Cap | Pharmaceuticals & Drugs
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Zydus Cadila gets tentative approval from US FDA for Glipizide ER tablets

Date: 16-09-2014

Zydus Cadila has received tentative approval from the US FDA (Food and Drug Administration) to market Glipizide Extended-release (ER) tablets in the strengths of 2.5 mg, 5 mg, and 10 mg. The drug falls in the ant-diabetic segment. The estimated sales in 2014 for Glipizide ER tablets is $90.1 million.

Following the tentative approval, the group now has 97 approvals and has so far filed 249 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. It is the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.