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Zydus Cadila gets tentative approval from US FDA for Glipizide ER tablets

16 Sep 2014 Evaluate

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.

Peers
Company Name CMP
Sun Pharma. Inds. 1840.00
Dr. Reddys Labs. 1222.50
Cipla 1388.90
Lupin 2061.85
Zydus Lifesciences 1212.00
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