Zydus gets USFDA nod for Diroximel Fumarate capsules

Regulatory product approvalBusiness Updates View source PDF Explain this filing

ZYDUSLIFE · price

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Price reactionminutes from the announcement price · days from the prior close

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₹945.20

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On the reaction day the stock moved 0.2 pts less than Nifty 100 and 0.1 pts less than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

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AI summary

Zydus Lifesciences has received final USFDA approval for Diroximel Fumarate Delayed-Release Capsules, 231 mg, used to treat relapsing forms of multiple sclerosis in adults. The reference brand, Vumerity, had annual US sales of about USD 999.4 million. The drug will be produced at Zydus SEZ facility. The group now holds 426 approvals and has filed 487 ANDAs since FY 2003-04.

Likely market impact

Strengthens US generics portfolio with a billion-dollar market opportunity. Positive for medium-term revenue.