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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, 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 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.
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