Zydus gets tentative USFDA nod for Macitentan Tablets
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Ahmedabad: Zydus Worldwide DMCC, a wholly-owned subsidiary of Cadila Healthcare Limited, 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 Pvt Ltd., 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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