Zydus Worldwide DMCC, a wholly owned subsidiary of Cadila Healthcare , has received tentative approval from the 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.
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