Zydus receives final approval from USFDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg

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Zydus receives final approval from USFDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg

By Pharmautility

July 15, 2025

Ahmedabad, India | July 15, 2025

Zydus Lifesciences Limited (including its subsidiaries and affiliates, hereafter referred to as “Zydus”) has received final approval from the U.S. Food and Drug Administration (USFDA) to market Celecoxib Capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths. The approved product is a generic version of the reference listed drug (RLD), Celebrex® Capsules.

💊 About Celecoxib

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation. It is commonly prescribed for:

Osteoarthritis and Rheumatoid Arthritis
Ankylosing Spondylitis
Menstrual Pain
Juvenile Rheumatoid Arthritis (for children aged 2 and above)

🏭 Manufacturing Details

The approved Celecoxib Capsules will be manufactured at Zydus Lifesciences Ltd’s SEZ facility in Ahmedabad, India.

📊 Market Overview

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

🏅 Regulatory Milestone

With this approval, Zydus now has 428 product approvals from the USFDA. Since the company started filing Abbreviated New Drug Applications (ANDAs) in FY 2003–04, it has submitted a total of 492 ANDAs (as of March 31, 2025).