Ipca Labs gets USFDA EIR for Ratlam facility
Mumbai: Ipca labs has recently announced that the Company's manufacturing facility situated at Sejavata, Ratlam, Madhya Pradesh has received United States Food and Drug Administration (USFDA)'s Establishment Inspection Report (EIR) classifying the manufacturing facility as Voluntary Action Indicated (VAI).
USFDA had inspected the said facility from 5th June, 2023 to 13th June, 2023 and issued Form 483 with eleven observations.
Read also: USFDA issues 11 observations to Ipca Labs Ratlam facility
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.
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.
Read also: Hitesh Kumar Maheshwari joins Ipca Labs as President - RnD (Formulations)
