Cadila Healthcare’s wholly owned subsidiary Zydus Pharmaceuticals (USA) Inc. has received the final approval from the United States Food & Drug Administration (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.
Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.
