Zydus gets tentative USFDA nod for Macitentan Tablets

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.

Zydus Cadila is an innovative, global pharmaceutical company headquartered in Ahmedabad, India. The company discovers, develops, manufactures and markets a broad range of healthcare therapies.

The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

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