Mumbai, March 15, 2018: Pharma Major, Panacea Biotec Ltd. has announced the receipt of Establishment Inspection Report (EIR) from the U.S. Food & Drug Administration (‘USFDA’) indicating the formal closure of the Inspection conducted by USFDA, 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 by USFDA indicating inspection is ‘closed’ means, 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 has state-of-the-art pharmaceutical formulation facility located at Baddi for Oral Solids and Oncology Parenteral Formulations. The Company has been supplying products in US markets for approved ANDAs manufactured in Oral Solids Dosage Facility. A number of abbreviated new drug applications (ANDAs) submitted by the Company, referring these facilities, are also at various stages of approval by USFDA, company said in a filing with BSE.
The Oral Solids manufacturing facility located at above site has a history of completion of 5 consecutive successful cGMP and Pre-Approval Inspections by USFDA in last 8 years. The manufacturing facility of Oncology Parenteral Formulations has been inspected successfully for the 2nd time by USFDA.
Commenting on the development, Dr. Rajesh Jain, Joint Managing Director, Panacea Biotec said’This EIR notification again demonstrates the Company’s ability to produce drugs in cGMP compliant environment in a sustainable manner. We remain committed to continue to manufacture and supply quality products to cater to patients’ needs across several markets including USA’
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