Cipla Limited announced that the United States Food and Drug Administration (USFDA) has completed its 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, conducted between February 18 and 20, 2025, concluded with Sitec Labs receiving two observations in Form 483. Cipla has assured that it will work closely with the USFDA to address these observations comprehensively within the stipulated time frame.
Earlier today, Cipla Limited announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Nilotinib Capsules in 50 mg, 150 mg, and 200 mg. This approval, granted on February 19, 2025, is a significant milestone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML), a form of blood cancer.
According to Cipla’s exchange filing, Nilotinib is an oncology drug available in capsule form for oral consumption. The drug is specifically indicated for treating chronic myeloid leukemia (CML) in Philadelphia chromosome-positive patients. Cipla has confirmed plans to launch Nilotinib Capsules in the U.S. market during the financial year 2025-26.
