Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (USFDA) to market its Celecoxib Capsules, further strengthening its expanding generics portfolio in the United States.
Celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), is widely prescribed for the management of pain and inflammation associated with various conditions, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and primary dysmenorrhea (menstrual pain). It is also indicated for the treatment of juvenile rheumatoid arthritis in children aged two years and above. The approved product will be manufactured at Zydus Lifesciences Ltd’s facility located in the Special Economic Zone (SEZ) in Ahmedabad, India.
According to IQVIA MAT data for May 2025, the annual U.S. sales for Celecoxib Capsules were estimated at approximately USD 122.6 million.
With this latest approval, Zydus has now received 428 final approvals and submitted a total of 492 Abbreviated New Drug Applications (ANDAs) since the commencement of its U.S. regulatory filings in FY 2003–04.
Zydus Lifesciences is a research-oriented global life sciences company engaged in the discovery, development, manufacturing, and marketing of a wide range of therapeutic solutions aimed at improving health and well-being.