Zydus receives final approval from USFDA for Celecoxib Capsules

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules in four strengths: 50 mg, 100 mg, 200 mg, and 400 mg. These capsules are a generic version of Celebrex, used to treat pain and inflammation associated with conditions like arthritis, ankylosing spondylitis, and menstrual pain.

Key Details:

– Approval Date: July 15, 2025
– Product: Celecoxib Capsules (50 mg, 100 mg, 200 mg, and 400 mg)
– Manufacturer: Zydus Lifesciences Limited, Ahmedabad, India
– US Market Size: Approximately $122.6 million (IQVIA MAT May 2025)
– Total USFDA Approvals: 428
– Total ANDAs Filed: 492 since FY 2003-04

Impact on Zydus Lifesciences:

– The company’s shares gained 0.66% on the BSE, quoting at Rs 973.55
– The approval is expected to boost Zydus Lifesciences’ presence in the US market for generic drugs

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg (USRLD: Celebrex  Capsules, 50 mg, 100 mg, 200 mg, and 400 mg).

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. Celecoxib capsules had annual sales of USD 122.6 mn in the United States (IQVIA MAT May 2025).

The group now has 428 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.