Zydus Lifesciences Limited has informed the Exchange regarding a press release dated July 15, 2025, titled "Zydus receives final approval from USFDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg".
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Zydus Lifesciences has received final approval from the USFDA to market Celecoxib Capsules in four strengths (50 mg, 100 mg, 200 mg, and 400 mg). Celecoxib is a generic version of Pfizer's Celebrex, a widely used anti-inflammatory painkiller prescribed for arthritis, ankylosing spondylitis, menstrual pain, and juvenile rheumatoid arthritis. The product will be manufactured at Zydus's SEZ facility in Ahmedabad. The reference drug had annual US sales of USD 122.6 million as of May 2025 (IQVIA data), representing a meaningful market opportunity. With this approval, Zydus's group tally rises to 428 ANDA approvals out of 492 ANDAs filed since FY 2003-04.
This approval strengthens Zydus's US generics portfolio and opens access to a USD 122+ million annual market, which could support incremental revenue from the US business in upcoming quarters. It reinforces the company's strong track record of consistent USFDA approvals, a positive signal for long-term growth, though typical generic competition may limit pricing and market-share gains.