Panacea Biotec, one of India's leading research based health management company, has received establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and Pre-Approval Inspection conducted by USFDA, at its Oncology Parenteral and Oral Solids Dosage formulation facilities at Malpur, Baddi, District Solan, Himachal Pradesh. 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.
The Oral Solids manufacturing facility located at above site has a history of completion of 4 consecutive successful cGMP and Pre-Approval Inspections by USFDA in last 7 years. The manufacturing facility of Oncology Parenteral Formulations has been inspected successfully for the first time by USFDA. Both Oral Solids and Oncology Parenteral formulation facilities were inspected by USFDA at the same time during the period November 30 - December 11, 2015. The release of EIR notification by USFDA indicating inspection activity 'Closed' means, the USFDA has concluded review of firm's manufacturing activities and the company is allowed to continue supply of all approved drug products by USFDA into inter-state commerce. The EIR notification also accelerates approval process for submitted drug product applications.
Panacea Biotec is the third largest biotechnology company as well as among the top 50 pharmaceutical companies of India. The company has product portfolio that’s caters therapeutics areas like pain management, diabetes and cardiovascular management, renal disease management, osteoporosis management, anti-tubercular, gastro-intestinal.
