Zydus Lifesciences Limited has informed the Exchange regarding a press release dated August 08, 2025, titled "Zydus receives final approval from USFDA for Prucalopride Tablets, 1 mg and 2 mg".

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

+2.2%Reaction day

₹934.20

prior close

₹940.95

announcement price

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Nifty 100market · index membership as recorded later (tracked since Jun 2026)+1.0%+1.3% vs market

Pharmaceuticals peers, median of 148sector+0.3%+1.9% vs sector

On the reaction day the stock moved 1.3 pts more than Nifty 100 and 1.9 pts more 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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Reaction day

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Next day

+2.2+0.6+1.6+0.3+1.9

+5.7+1.2+4.5+0.6+5.1

+5.5+1.2+4.4-0.3+5.9

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+0.5+5.6-5.2-4.4+4.8

UpDownMarket · Nifty 100Sector · Pharmaceuticals peers, median of 148Pending

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AI summary

Zydus Lifesciences has received final approval from the USFDA to market Prucalopride Tablets in 1 mg and 2 mg strengths, a generic of Motegrity used to treat chronic idiopathic constipation. The product targets a US market worth around USD 186.8 million annually (IQVIA MAT June 2025). Manufacturing will take place at the company's SEZ facility in Ahmedabad. With this approval, Zydus now has 422 total USFDA approvals and has filed 483 ANDAs since FY 2003-04.

Likely market impact

This approval lets Zydus launch a generic version of a blockbuster constipation drug in the large US market, opening a new revenue stream. The addressable market size of ~USD 187 million makes it a meaningful addition, though actual gains will depend on launch timing and pricing competition.