USFDA issues 5 observations to Cipla US arm
Mumbai: Cipla has recently announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with five inspectional observations at the manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company located in Central Islip, Long Island, New York, USA.The inspection was held from 11th September, 2023 to 19th September,...
Mumbai: Cipla has recently announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with five inspectional observations at the manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company located in Central Islip, Long Island, New York, USA.
The inspection was held from 11th September, 2023 to 19th September, 2023.
The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen.
"On conclusion of the inspection, InvaGen has received 5 inspectional observations in Form 483. There are no repeat or data integrity (DI) observations," the Company stated in a BSE filing.
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 is committed to address these comprehensively within stipulated time," it added.
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Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai.
The Company specializes in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments. Cipla's 47 manufacturing sites worldwide produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to 86 markets.
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