Shares of Zydus Lifesciences Ltd are buying and selling flat after hitting a day’s excessive of Rs 952.95 on 14th November, at the same time as the corporate introduced it has obtained remaining approval from the USFDA for Diroximel Fumarate delayed-release capsules (231 mg), used to deal with relapsing types of a number of sclerosis (MS) in adults.
Zydus mentioned the product, a generic model of Vumerity, might be made at its SEZ facility in Ahmedabad. Citing IQVIA MAT information for September 2025, the corporate famous that Diroximel Fumarate capsules recorded annual US gross sales of USD 999.4 million.
With this approval, Zydus now has 426 USFDA approvals out of 487 ANDA filings since FY2003-04.
Individually, the USFDA just lately accomplished a pre-approval inspection of Zydus’ oncology injectable plant in SEZ-1, Ahmedabad. The inspection, performed from 4th to thirteenth November, ended with two observations. Nonetheless, the corporate mentioned no information integrity points had been discovered. Zydus added that it’s going to work with the regulator to resolve the observations rapidly.
These updates observe Zydus’ robust Q2 FY26 outcomes final week. The web revenue rose 39% to Rs 1,259 crore and income grew 17% to Rs 6,123 crore. This development was led by strong efficiency in its US and India formulations companies. The corporate additionally reported a foreign exchange achieve of Rs 414 crore and invested Rs 482 crore in R&D. This reinforces its deal with advanced generics and innovation.
At 1:02 PM, shares of Zydus Lifesciences had been buying and selling 0.026% decrease at Rs 943.90 on NSE.
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