Zydus Lifesciences gets USFDA Nod for Celecoxib Capsules

Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Celecoxib Capsules, marking another addition to its growing U.S. generics portfolio.

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. It is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain. It is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old. Celecoxib capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.

According to IQVIA MAT data (May 2025), Celecoxib Capsules recorded annual sales of approximately USD 122.6 million in the U.S. market.

 

With this approval, Zydus has now secured a total of 428 final approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since it began its U.S. regulatory filing process in FY 200304.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24.

The counter shed 0.14% to Rs 967.15 on the BSE.

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