Cipla Secures USFDA Approval for Nilotinib Capsules

Cipla has received final approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Nilotinib Capsules in 50 mg, 150 mg, and 200 mg dosages. This approval represents a significant advancement in Cipla’s efforts to expand its oncology portfolio and provide critical treatment options for cancer patients. The company aims to launch Nilotinib in the United States during the financial year 2025-26, reinforcing its presence in the pharmaceutical industry.

Nilotinib: A Targeted Therapy for CML

Nilotinib is an oral medication used for treating Philadelphia chromosome-positive chronic myeloid leukaemia (CML), a cancer that affects the bone marrow and blood. It is primarily prescribed for adult patients, with the average age of diagnosis being 64. By targeting specific proteins involved in the growth of leukaemia cells, Nilotinib helps in managing the disease more effectively.

USFDA Inspection at Sitec Facility

The United States Food and Drug Administration (USFDA) recently conducted a current Good Manufacturing Practices (cGMP) inspection at the analytical testing facility of Sitec Labs Limited, a wholly owned subsidiary of Cipla, located in Mahape, Navi Mumbai. The inspection took place from 18th to 20th February 2025 and concluded with Sitec receiving two observations in Form 483. Cipla remains committed to addressing these observations within the stipulated time in close coordination with the USFDA.

Cipla Share Performance

As of February 21, 2025, at 3:00 PM, the shares of Cipla are trading flat at ₹1,477.65 per share, reflecting a minor decline of 0.14% from the previous day’s closing price. Over the past month, the stock has registered a surge of 3.47%.

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