Cadila Healthcare’s arm gets USFDA’s tentative approval for Macitentan tablets

15 Apr 2020 Evaluate

Cadila Healthcare’s wholly owned subsidiary -- Zydus Worldwide DMCC has received tentative approval from the US Food and Drug Administration (USFDA) to market Macitentan Tablets (US RLD: Opsumit Tablets), 10 mg. The medication is indicated for the treatment of pulmonary arterial hypertension. The drug will be manufactured at CMO Umedica Laboratories, Vapi, Gujarat.

The group now has 287 approvals and has so far filed over 386 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.

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