Zydus Cadila receives USFDA approval for Apremilast Tablets

September 24,2021

Zydus Cadila's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the USFDA to market Apremilast Tablets in the strengths of 10 mg, 20 mg, 30 mg (US RLD: Otezla® Tablets). Zydus' Apremilast Tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 323 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

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