Cipla arm gets zero Form 483 observations from USFDA for USA facility

Published On 2023-05-03 07:00 GMT   |   Update On 2023-05-03 07:00 GMT
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Mumbai: Cipla has recently announced that the US Food and Drug Administration has concluded inspection with zero Form 483 observations at the Fall River facility of the Company's wholly-owned subsidiary InvaGen Pharmaceuticals.

The inspection was conducted from 24th April, 2023 to 1st May, 2023.

"We hereby notify that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the manufacturing facility of InvaGen Pharmaceuticals Inc. (wholly owned subsidiary of the Company) located in Fall River, Massachusetts, USA, from 24th April, 2023 to 1st May, 2023," the Company informed in a recent BSE filing.
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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.

Read also: Cipla joins hands with Novartis Pharma AG to market diabetes drug Galvus in India

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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