Zydus receive tentative USFDA approval for Macitentan tablets

On Wednesday, Zydus Worldwide DMCC, a wholly-owned subsidiary of Cadila Healthcare Limited, announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) to market Macitentan tablets (US RLD: Opsumit tablets), 10 mg.

The medication indicated is used for the treatment of pulmonary arterial hypertension. The drug will be manufactured at CMO Umedica Laboratories Pvt Ltd, Vapi (Gujarat). The group stated that it has now 287 approvals and has so far, filed over 386 ANDAs since the commencement of the filing process in FY 2003-04.

Cadila Healthcare Limited manufactures and markets healthcare solutions ranging from formulations, active pharmaceutical ingredients, vaccines, diagnostics, health and dietetic foods, animal healthcare to cosmeceuticals. Its products are available in tablets, capsules, injections, liquids, dry syrups, powders, granules and ointments.

On Wednesday, the stock closed at Rs 339.05, down by 4.13 per cent or Rs 14.60 per share. The 52-week high is recorded at Rs 378 and the 52-week low is Rs 206.45 on BSE.