Zydus Lifesciences gets USFDA nod for multiple sclerosis drug; Concludes oncology plant inspection

Zydus Lifesciences Ltd has received final approval from the US Food and Drug Administration (USFDA) for its Diroximel Fumarate delayed-release capsules (231 mg), used in the treatment of relapsing forms of multiple sclerosis (MS) in adults.

The product, a generic version of Vumerity, will be manufactured at the company’s SEZ facility in Ahmedabad, the company said in the exchange filing.

The company also stated IQVIA MAT data (September 2025), according to which Diroximel Fumarate capsules had annual

sales of USD 999.4 million in the US market.

With this approval, Zydus’ total USFDA approvals now stand at 426, out of 487 ANDA filings since FY2003-04.

Meanwhile, the USFDA recently concluded a pre-approval inspection at Zydus’ oncology injectable manufacturing site in SEZ-1, Ahmedabad, conducted between November 4 and 13, 2025.

The inspection ended with two observations, though the company confirmed there were no data integrity issues. Zydus said it will work closely with the USFDA to address the observations expeditiously.

The dual updates come on the heels of Zydus reporting a robust Q2 FY26 performance last week, with net profit surging 39% year-on-year to ₹1,259 crore and revenue climbing 17% to ₹6,123 crore, driven by strong growth in its US and India formulations businesses.

The company also recorded a foreign exchange gain of ₹414 crore and invested ₹482 crore (7.9% of revenue) in R&D, underscoring its continued focus on complex generics and innovation.