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Drug firm Unichem Laboratories Monday said its active pharmaceutical ingredient (API) manufacturing units at Pithampur and Roha have received Establishment Inspection Reports (EIR) from the US health regulator.
The company’s API manufacturing facilities have received EIRs from the United States Food and Drug Administration (USFDA) indicating closure of inspections at both the facilities, Unichem Laboratories said in a filing to the BSE.
The inspection at Pithampur was conducted by the FDA from July 23, to July 27, 2018 and the inspection at Roha was conducted by the FDA from July 30, to August 3, 2018, it added.
The USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
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