Shares of Zydus Lifesciences Ltd are trading flat after hitting a day’s high of Rs 952.95 on 14th November, even as the company announced it has received final approval from the USFDA for Diroximel Fumarate delayed-release capsules (231 mg), used to treat relapsing forms of multiple sclerosis (MS) in adults.

Zydus said the product, a generic version of Vumerity, will be made at its SEZ facility in Ahmedabad. Citing IQVIA MAT data for September 2025, the company noted that Diroximel Fumarate capsules recorded annual US sales of USD 999.4 million.

With this approval, Zydus now has 426 USFDA approvals out of 487 ANDA filings since FY2003-04.

Separately, the USFDA recently completed a pre-approval inspection of Zydus’ oncology injectable plant in SEZ-1, Ahmedabad. The inspection, conducted from 4th to 13th November, ended with two observations. However, the company said no data integrity issues were found. Zydus added that it will work with the regulator to resolve the observations quickly.

These updates follow Zydus’ strong Q2 FY26 results last week. The net profit rose 39% to Rs 1,259 crore and revenue grew 17% to Rs 6,123 crore. This growth was led by solid performance in its US and India formulations businesses. The company also reported a forex gain of Rs 414 crore and invested Rs 482 crore in R&D. This reinforces its focus on complex generics and innovation.

At 1:02 PM, shares of Zydus Lifesciences were trading 0.026% lower at Rs 943.90 on NSE.

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