Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has classified the current Good Manufacturing Practices (cGMP) inspection at the analytical testing facility of Sitec Labs Limited, wholly owned subsidiary of the Company located in Mahape, Navi Mumbai as Voluntary Action Indicated (VAI).The inspection was held from 18th to 20th February, 2025. In February, the facility had initially received two observations in Form 483 from the USFDA.Read also: USFDA issues 2 observations for Cipla arm Mahape facility 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. 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 gets CDSCO Panel nod to study Revefenacin Inhalation solution”Pursuant to the provisions of Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements)
Regulations, 2015, and further to our intimation dated 20th February, 2025, regarding the United States Food and
Drug Administration (USFDA) 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, we hereby notify that the USFDA, via email communication dated 16th May, 2025
(11.57 pm IST), has classified the above-referred inspection as Voluntary Action Indicated (VAI),” Cipla stated in a BSE filing.