Panacea Biotec ends positive on receiving EIR from USFDA
DSIJ Intelligence / 21 Nov 2016
Panacea Biotec has received establishment inspection report (EIR) from the US Food and Drug Administration(USFDA).
Panacea Biotec has received establishment inspection report (EIR) from the US Food and Drug Administration(USFDA). The company’s EIR is 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, Himachal Pradesh. The company has been supplying products in US markets for approved ANDAs manufactured in oral solids dosage facility.
Panacea Biotec’s 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 oral solids manufacturing facility located at above site has a history of completion of four consecutive successful cGMP and Pre-Approval Inspections by USFDA in last 7 years. Its manufacturing facility of Oncology Parenteral Formulations has been inspected successfully for the first time by USFDA.
The share price of Panacea Biotec increased by 7.25 per cent on bourses in early trades; and closed at Rs 108.1 on intraday basis.
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