Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to market Celecoxib Capsules in the U.S. market. The approval covers four dosage strengths — 50 mg, 100 mg, 200 mg, and 400 mg — which are the generic equivalents of Pfizer’s Celebrex®.
Celecoxib is a widely used nonsteroidal anti-inflammatory drug (NSAID) that helps reduce pain and inflammation in conditions like arthritis, ankylosing spondylitis, and menstrual cramps. It’s also prescribed to treat juvenile rheumatoid arthritis in children aged 2 years and above.
The approved product will be manufactured at Zydus’ SEZ facility in Ahmedabad. In the U.S. alone, Celecoxib capsules recorded annual sales of around USD 122.6 million as of May 2025 (IQVIA MAT data).
With this approval, Zydus now has 428 total ANDA approvals, further strengthening its U.S. generics portfolio. Since it began filing ANDAs in FY 2003-04, the group has submitted 492 applications in total.
