USFDA issues 11 observations to Ipca Labs Ratlam facility
Ratlam: Ipca Laboratories Limited has announced that the Company has received eleven observations from the United States Food and Drug Administration (USFDA) after an inspection at the Company’s APIs manufacturing facility situated at Ratlam, Madhya Pradesh.The inspection was held from 5th June, 2023 to 13th June, 2023."At the conclusion of the inspection, the US FDA issued a Form 483 with...
Ratlam: Ipca Laboratories Limited has announced that the Company has received eleven observations from the United States Food and Drug Administration (USFDA) after an inspection at the Company’s APIs manufacturing facility situated at Ratlam, Madhya Pradesh.
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.
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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