Zydus Cadila gets tentative approval from USFDA to market Tofacitinib Extended-Release Tablets

19 Oct 2020 Evaluate

Zydus Cadila has received tentative approval from the United States Food & Drug Administration (USFDA) to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: Xeljanz XRTablets). It is recommended for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC). The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 308 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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