Panacea Biotec receives EIR from USFDA for Baddi facility

10 Mar 2018 Evaluate

Panacea Biotec has received Establishment Inspection Report (EIR) from the US Food & Drug Administration (USFDA) indicating the formal closure of the Inspection conducted by the regulator, at its Pharmaceutical Formulation Facility for Oncology Parenteral and Oral Solids Dosage at Malpur, Baddi, District Solan, Himachal Pradesh, India.

The release of EIR notification indicates that the USFDA has concluded review of the company’s manufacturing activities and the company is allowed to continue supply of all the approved drug products by USFDA into inter-state commerce. The EIR notification also accelerates approval process for submitted drug product applications.

Panacea Biotec is a leading research based Biotechnology Company with established research, manufacturing and marketing capabilities. It is one of the largest vaccine producers and biotechnology companies in India.

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