Zydus Cadila gets tentative approval to market Fingolimod Capsules

24 Jun 2021 Evaluate

Zydus Cadila has received tentative approval from the USFDA to market Fingolimod Capsules in the strength of .25 mg (US RLD: Gilenya Capsules). Earlier, in October 2020, the group was granted approval to market Fingolimod Capsules in the strength of 5mg. Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS).

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 319 approvals and has so far filed over 400 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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