Zydus Lifesciences Ltd. has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Jaythari (Deflazacort) Tablets, 6 mg, 18 mg, 30 mg, and 36 mg (USRLD: Emflaza Tablets, 6 mg, 18 mg, 30 mg, and 36 mg).
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Jaythari (Deflazacort) will be produced at Doppel Farmaceutici S.r.l., Italy facility.
The group now has 424 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.
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