Zydus Cadila gets final approval from USFDA for Nifedipine, Cholestyramine

03 Jul 2018 Evaluate

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Nifedipine Extended-Release Tablets USP (Adalat CC) in the strengths of 30 mg, 60 mg, and 90 mg. It is used to treat high blood pressure and angina (chest pain brought on by exercise or stress). It works to control blood pressure and reduce the number of angina attacks by relaxing blood vessels.  Nifedipine will be manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad.

The group also received the final approval to market Cholestyramine for Oral Suspension USP (Questran), 4 g resin per pouch or scoopful. It is used along with a proper diet to lower cholesterol in the blood. Lowering cholesterol helps decrease the risk for strokes and heart attacks. It will be manufactured at the group’s formulations manufacturing facility at Baddi. In line with this, the group has now has 201 approvals and has so far filed over 330 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.

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