Zydus Life Science has achieved a significant milestone in its pharmaceutical portfolio expansion. The company announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules in multiple strengths.

FDA Approval Details

The approval covers Celecoxib Capsules in four strengths:

• 50 mg
• 100 mg
• 200 mg
• 400 mg

This generic version is equivalent to the brand-name drug Celebrex® Capsules, which is widely used for pain management.

About Celecoxib

Celecoxib is classified as a nonsteroidal anti-inflammatory drug (NSAID). It functions by reducing hormones that cause inflammation and pain in the body. The drug is prescribed for various conditions, including:

• Arthritis
• Ankylosing spondylitis
• Menstrual pain
• Juvenile rheumatoid arthritis in children 2 years and older

Market Potential

The approval positions Zydus Lifesciences to tap into a substantial market. According to IQVIA data, Celecoxib capsules generated annual sales of $122.60 million in the United States for the 12 months ending May 2025.

Manufacturing and Production

Zydus will manufacture the newly approved Celecoxib capsules at its state-of-the-art facility:

• Location: Zydus Lifesciences Ltd (SEZ), Ahmedabad

Zydus's Growing Portfolio

This latest approval further strengthens Zydus's position in the U.S. pharmaceutical market:

• Total FDA Approvals: 428
• ANDA Filings: 492 (as of March 31, 2025)

The company has been consistently expanding its portfolio since it began filing ANDAs in the 2003-04 fiscal year.

Company Statement

Dhaval N. Soni, Company Secretary and Compliance Officer of Zydus Lifesciences Limited, confirmed the approval in a press release to the stock exchanges, emphasizing the company's commitment to expanding its pharmaceutical offerings and addressing patient needs in pain management.

This FDA approval marks another step forward for Zydus Lifesciences in its mission to provide accessible and effective healthcare solutions to patients in the United States and globally.

Zydus Lifesciences Limited has achieved a significant milestone in its pharmaceutical portfolio expansion. The company announced on July 15, 2025, that it has received final approval from the United States Food and Drug Administration (USFDA) for its Celecoxib Capsules in multiple strengths.

FDA Approval Details

The approval covers Celecoxib Capsules in four different strengths: 50 mg, 100 mg, 200 mg, and 400 mg. This generic version is equivalent to the brand-name drug Celebrex® Capsules, which is widely used in the treatment of various inflammatory conditions.

About Celecoxib

Celecoxib is classified as a nonsteroidal anti-inflammatory drug (NSAID). It functions by reducing hormones responsible for inflammation and pain in the body. The drug is primarily used to treat pain and inflammation associated with conditions such as:

• Arthritis
• Ankylosing spondylitis
• Menstrual pain
• Juvenile rheumatoid arthritis in children aged 2 years and older

Market Potential

The approval of Celecoxib Capsules opens up a significant market opportunity for Zydus Lifesciences. According to IQVIA data, the annual sales of Celecoxib capsules in the United States stood at $122.60 million as of May 2025. This represents a substantial market that Zydus can now tap into with its generic offering.

Manufacturing and Production

Zydus plans to manufacture the newly approved Celecoxib capsules at its facility in Ahmedabad. Specifically, production will take place at the Zydus Lifesciences Ltd (SEZ) unit in Ahmedabad, showcasing the company's domestic manufacturing capabilities.

Zydus's Growing Portfolio

This latest approval further strengthens Zydus's position in the U.S. generic drug market. As of March 31, 2025, the company has achieved several notable milestones:

• Total of 428 USFDA approvals
• 492 Abbreviated New Drug Applications (ANDAs) filed since the commencement of the filing process in FY 2003-04

These figures underscore Zydus's commitment to expanding its presence in the U.S. pharmaceutical market and its ongoing efforts to bring a wide range of generic medications to patients.

The approval of Celecoxib Capsules not only adds to Zydus's product portfolio but also reinforces its capabilities in developing and manufacturing complex generic formulations. As the company continues to grow its presence in the U.S. market, this latest approval marks another step forward in its mission to provide accessible and affordable healthcare solutions.