USFDA15 Jul 2025, 03:50 pm
Zydus Lifesciences Ltd Receives Final USFDA Approval for Celecoxib Capsules
AI Summary
Zydus Lifesciences Ltd has received final approval from the USFDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg. The capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by various conditions. The group now has 428 approvals and has filed 492 ANDAs since the commencement of the filing process in FY 2003-04. Celecoxib capsules had annual sales of USD 122.6 mn in the United States (IQVIA MAT May 2025).
Key Highlights
- Zydus Lifesciences Ltd receives final approval from USFDA for Celecoxib Capsules
- Celecoxib Capsules are available in 50 mg, 100 mg, 200 mg, and 400 mg strengths
- Celecoxib Capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
- Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation
- Zydus Lifesciences Ltd now has 428 USFDA approvals and has filed 492 ANDAs since FY 2003-04