USFDA issues EIR for Ipca Labs SEZ Indore facility
Mumbai: Ipca Labs has announced that the United States of Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR) for the Company's formulations manufacturing facility situated at SEZ Indore and classified it as voluntary action indicated (VAI).
The regulator had inspected inspected the facility from 15th June, 2023 to 23rd June, 2023 and issued Form 483 with eight observations.
"This manufacturing facility has now received Establishment Inspection Report classifying the manufacturing facility as “Voluntary Action Indicated (VAI) and that that this facility is considered to be in a minimally acceptable state of compliance with regard to current good manufacturing practice (CGMP)," the Company stated in a BSE filing.
Voluntary action indicated (VAI), which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
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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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