Zydus Gets USFDA Nod for Pramipexole Dihydrochloride ER Tab | CORPORATE ETHOS

Zydus Gets USFDA Nod for Pramipexole Dihydrochloride ER Tab

By: | December 14, 2017
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Dec 14: Zydus Pharmaceuticals (USA) Inc., a wholly-owned subsidiary of Cadila Healthcare Ltd and part of Zydus group, on Thursday said that it has received the final approval from the USFDA to market its Pramipexole Dihydrochloride Extended-Release Tablets in strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg.

According to the company, the drug is indicated to treat signs and symptoms of Parkinson’s disease (PD).

“The group also received the final approval from the USFDA to market Nitrofurantonin Capsules USP (macrocrystals), 50 mg and 100 mg, which is indicated to treat acute uncomplicated urinary tract infections. Both the drugs will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad,” the company said.

Based in Ahmedabad, the Pankaj R Patel promoted Zydus Cadila Group is a research driven drug maker that discovers, develops, manufactures and markets a broad range of healthcare therapies.

The group now has more than 175 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.