USFDA inspection: Ipca Labs Piparia facility gets VAI status

Published On 2023-08-24 09:45 GMT   |   Update On 2023-08-24 09:45 GMT
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Mumbai: Ipca Labs has announced that the United States Food and Drug Administration (USFDA) has determined the inspection classification of the Piparia (Silvassa) formulations manufacturing facility as Voluntary Action Indicated (VAI). 

The USFDA had inspected the said facility from 18th April, 2023 to 26th April, 2023 and issued three observations under USFDA Form 483.

Voluntary action indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. 

"Based on this inspection, this facility is considered to be in a minimally acceptable state of compliance with regards to current good manufacturing practice (CGMP)," the Company stated in a BSE filing.

Ipca Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai. The Company was founded by group of businessmen and medical professionals in 1949. It produces theobromine, acetyl thiophene, and p-bromotoluene as active pharmaceutical ingredients (APIs). Ipca sells these APIs and their intermediates globally. Ipca is a fully-integrated pharmaceutical company that manufactures over 350 formulations and 80 APIs for various therapeutic segments.

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