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The Establishment Inspection Report (EIR) has been received by the drug firm Panacea Biotec from the US health regulator after successful inspection of its manufacturing facilities at Baddi in Himachal Pradesh.
Panacea Biotec has said in a BSE filing that the company has received EIR from the US Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and pre-approval inspection conducted at its oncology parenteral and oral solids dosage formulation facilities at Baddi.
It further said that “The company has been supplying products in the US markets for approved ANDAs manufactured in the oral solids dosage facility.”
