Cadila Healthcare on Wednesday said its subsidiary has received approval from the US health regulator to market Macitentan tablets, used to treat high blood pressure, in the American market.
Zydus Worldwide DMCC, a wholly owned subsidiary of the company, has received tentative approval from the US Food and Drug Administration (USFDA) to market Macitentan tablets, Cadila Healtcare said in a statement.
The tablets are indicated for treatment of pulmonary arterial hypertension and will be manufacturedat Vapi-based CMOUmedica Laboratories, it added.
The Zydus Cadila group now has 287 approvals and has so far filed over 386 abbreviated new drug applications since the commencement of the filing process in 2003-04, the company said.
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