USFDA issues 2 observations for Cipla arm Mahape facility
Mumbai: Cipla, an Indian multinational pharmaceutical company, has announced that the United States Food and Drugs Administration (USFDA) has issued two observations at the conclusion of the inspection at the analytical testing facility of Sitec Labs Limited, wholly owned subsidiary of the Company located in Mahape, Navi Mumbai.
The current Good Manufacturing Practices (‘cGMP’) inspection was conducted from 18th to 20th February, 2025.
On conclusion of the inspection, Sitec received 2 (two) observations in Form 483.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company will work closely with the USFDA and remains committed to address these observations comprehensively within stipulated time," Cipla stated in a BSE filing.
Read also: Cipla Global Chief Manufacturing Officer Rajeev Kumar Sinha resigns
In addition to the inspection at the Company's arm, Cipla has also received final approval from the USFDA for the New Drug Application (‘NDA’) submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’. Nilotinib is an oncology category product in capsule form for oral consumption and is used for treatment of philadelphia chromosome positive chronic myeloid leukemia.
Read also: Cipla bags USFDA nod for chronic myeloid leukemia drug Nilotinib
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.
