Zydus Worldwide DMCC, a wholly owned subsidiary of Cadila Healthcare Limited, has received tentative approval from the US FDA to market macitentan tablets 10 mg.
The medication is indicated for the treatment of pulmonary arterial hypertension. The drug will be manufactured at CMO Umedica Laboratories Pvt Ltd, Vapi, Gujarat.
The group 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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