Cadila’s arm gets tentative approval from USFDA for Pregabalin Capsules

01 Dec 2017 Evaluate

Cadila Healthcare’s wholly owned subsidiary -- Zydus Pharmaceuticals (USA) has received the tentative approval from the United States Food & Drug Administration (USFDA) to market Pregabalin Capsules in strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. The drug is used for management of certain kinds of seizures, neuropathic pain (nerve pain) and fibromyalgia. It will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad.

The group now has more than 175 approvals and has so far filed over 310 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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