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Zydus Cadila receives tentative approval from USFDA for Fingolimod Capsules .25mg

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.

 

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