Zydus Lifesciences Share Price Rises After USFDA Approval for Celecoxib Capsules

Market Performance

On July 16, shares of Zydus Lifesciences opened slightly higher following a key regulatory update.

• Opening Price (09:19 AM): ₹973.55
• Price Change: Up by ₹6.40
• Percentage Increase: 0.66%
• Listing Exchange: BSE

The share movement reflected positive sentiment driven by an essential regulatory clearance in the United States.

Main News: Final USFDA Nod for Celecoxib Capsules

Zydus Lifesciences has received final clearance from the USFDA for its Celecoxib Capsules in four dosage forms: 50 mg, 100 mg, 200 mg, and 400 mg variants.

Celecoxib is a widely prescribed nonsteroidal anti-inflammatory drug (NSAID) that helps reduce the chemicals in the body responsible for pain and inflammation.

Therapeutic Uses Include:

• Arthritis-related pain
• Ankylosing spondylitis
• Menstrual cramps
• Juvenile rheumatoid arthritis (in children aged two and older)

Production of these capsules will take place at the company's manufacturing facility in Ahmedabad.

Company Details

Zydus Lifesciences continues to build a robust portfolio in the generic pharmaceutical market.

• Total USFDA Approvals to Date: 428
• Cumulative ANDA Filings Since FY 2003-04: 492

This recent approval adds to the company's momentum in expanding its product offerings in key therapeutic segments globally.

In a separate development, the company's oncology injectable plant at SEZ 1, near Matoda, Ahmedabad, underwent a US FDA inspection from June 9 to June 18, which resulted in two official observations.

Summary of the Article

The Zydus Lifesciences share price posted a mild gain of 0.66% on July 16 after the company announced it had received final USFDA clearance for its Celecoxib Capsules. Available in four strengths, the medication addresses a variety of inflammation-related conditions and will be manufactured in Ahmedabad.

With 428 USFDA approvals and 492 ANDA filings to its name, Zydus continues to solidify its presence in the global generic drug market, even as it addresses compliance observations from recent inspections.