Cipla receives USFDA nod for Nilotinib Capsules

Cipla announced that it has received final approval from the United States Food and Drug Administration (USFDA) for the new drug application (NDA) submitted for 'Nilotinib Capsules 50, 150 and 200 mg' on 19 February 2025.

Nilotinib is indicated for the treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML), a cancer that affects the bone marrow and blood.

Nilotinib, available in capsule form for oral consumption, is used to treat Philadelphia Chromosome Positive Chronic Myeloid Leukemia, a form of leukemia that primarily affects adults, with the average age of diagnosis being 64.

Meanwhile, the USFDA conducted a Current Good Manufacturing Practices (cGMP) inspection at the analytical testing facility of Sitec Labs, a wholly owned subsidiary of Cipla, located in Mahape, Navi Mumbai, from 18 February to 20 February, 2025.

 

Following the inspection, Sitec received two observations in Form 483. The company is fully committed to addressing these observations in a timely and comprehensive manner.

Cipla will collaborate closely with the USFDA to resolve the issues within the specified timeframe, ensuring continued compliance with regulatory standards and maintaining its commitment to high-quality manufacturing practices.

Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets.

The pharma majors consolidated net profit jumped 48.73% to Rs 1,570.51 crore in Q3 FY25 as against Rs 1,055.90 crore reported in Q3 FY24. Total revenue from operations grew by 7.10% year on year (YoY) to Rs 7,072.97 crore in the quarter ended 31 December 2024.

Share of Cipla shed 0.17% to Rs 1,477.25 on the BSE.

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