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Writer's pictureSanjay Trivedi

Zydus receives final approval from USFDA for Pramipexole Dihydrochloride Extended-Release Tablets &a


Zydus Pharmaceuticals (USA) Inc., a wholly owned subsidiary of Cadila Healthcare Limited has received the final approval from the USFDA to market 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. 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 Nitrofurantoin 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 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.

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