Cipla bags USFDA nod for chronic myeloid leukemia drug Nilotinib

Mumbai: Pharma major, Cipla, 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 19th February 2025.

Nilotinib is an oncology category product in capsule form for oral consumption and is used for treatment
of philadelphia chromosome positive chronic myeloid leukemia (CML).
Philadelphia chromosome positive chronic myeloid leukemia is a bone marrow cancer that is caused by a genetic accident.
The product is expected to be
launched in FY 2025-26 in the United States of America.
Medical Dialogues team had earlier reported that Cipla had completed an investment of approx. ZAR 900 million in Cipla Medpro South Africa Proprietary Limited, South Africa, a wholly owned subsidiary in South Africa against allotment of 40,742,417 shares. CMSA, is a wholly owned subsidiary of Cipla Limited, and is the holding company for the group operations in South Africa.The group is involved in the manufacturing, marketing, and supply of pharmaceutical products. The investment will be utilised to reduce inter-group debt and improve the capital structure of CMSA and its subsidiaries, the Company had said.

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. It has strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. It has 47 manufacturing sites around the world which produces 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.

Read also: Cipla elevates Achin Gupta as new Global Chief Operating Officer

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