Unichem Labs gets EIR from USFDA for Roha API facility
Mumbai: Unichem Labs has announced that the company has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Roha.
The inspection was conducted by the USFDA from 16th June 2025 to 20th June 2025. Following the inspection, the company had received three observations for the facility.
The USFDA has now classified the inspection as Voluntary Action Initiated (VAI) and issued the EIR.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
Read also: Unichem Labs Roha facility gets 3 USFDA observations
Headquartered in Mumbai, Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. The company was founded in 1944 by Padmabhushan Late Mr. Amrut V Mody. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.
Read also: Sandip Ghume to resign as Unichem Labs Deputy CFO, Key Managerial Personnel
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