Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’

Syngene International Limited

Syngene International Limited has informed that the USFDA conducted a pre-approval and cGMP inspection covering commercial manufacturing activities for the US market at the Bengaluru facilities from February 10 – 20, 2025. At the conclusion of the inspection, the USFDA issued Form 483 with five observations. The company will work closely with USFDA and remains committed to addressing these observations comprehensively within the stipulated time.

Cipla Limited

Cipla Limited 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). The product is expected to be launched in FY 2025-26 in the United States of America.

Cipla Limited

The United States Food and Drugs Administration (USFDA) has conducted a current Good Manufacturing Practices (cGMP) inspection at the analytical testing facility of Sitec Labs Limited, wholly owned subsidiary of the company (Sitec) located in Mahape, Navi Mumbai from 18th to 20th February, 2025. At the conclusion of the inspection, Sitec received two observations in Form 483. The company will work closely with the USFDA and remains committed to address these observations comprehensively within stipulated time.