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".
ZYDUSLIFE · price
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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.
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.