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Zydus Lifesciences gets USFDA nod for its painkiller Celecoxib capsules

The company said that the medicine is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain

Zydus Lifesciences, Zydus

Zydus Lifesciences on Tuesday closed at ₹967.15, down ₹1.35 or 0.14 per cent on the BSE | Photo: X@ZydusUniverse

Aman Sahu New Delhi

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Zydus Lifesciences on Tuesday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its painkiller medicine capsule named Celebrex (Celecoxib capsules).
 
The company said that the medicine is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain, along with juvenile rheumatoid arthritis in children who are at least 2 years old. The capsules will be produced at Zydus Lifesciences Ltd, Ahmedabad.
 
Celecoxib capsules had sales of $122.6 million in the US in the 12-month period ending May 2025. 
The company also noted that it now has 428 approvals out of 492 filed applications since the commencement of the filing process in FY2003–04. 
 
 
The clearance is important as earlier this year, the company came under scrutiny following surveillance inspections at its Gujarat facility by the USFDA. Later, the company said in a regulatory filing to NSE that “the inspection concluded with six observations and none of them were related to data integrity."
 
The company reported in May that its consolidated net profit slipped about 1 per cent year-on-year (Y-o-Y) to ₹1,171 crore in the March quarter of financial year 2025 (Q4FY25); however, revenue soared 18 per cent Y-o-Y to ₹6,527.9 crore.
 
The company is yet to file its earnings report for the first quarter of FY26.
 
Zydus Lifesciences on Tuesday closed at ₹967.15, down ₹1.35 or 0.14 per cent on the BSE.
 

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First Published: Jul 15 2025 | 6:04 PM IST

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