Zydus Receives Final USFDA Approval for Celecoxib Capsules..
Varahimedia.com,Ahmedabad, India, July 15, 202:Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as “Zydus”), has received final approval from the
Varahimedia.com,Ahmedabad, India, July 15, 202:Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as “Zydus”), has received final approval from the United States Food and Drug Administration (USFDA) for its Celecoxib Capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths. These capsules are the generic version of Celebrex® (celecoxib capsules) in the U.S. market.
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain and inflammation. It is commonly prescribed for conditions such as:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Menstrual pain
- Juvenile rheumatoid arthritis (for children aged 2 years and older)
The approved product will be manufactured at the company’s SEZ facility in Ahmedabad. According to IQVIA MAT (May 2025) data, the annual U.S. market for celecoxib capsules was approximately USD 122.6 million.
This latest approval brings Zydus’ total USFDA-approved products to 428, with 492 Abbreviated New Drug Applications (ANDAs) filed since FY 2003-04.
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