Panacea Biotec shines on receiving EIR report from USFDA for Baddi plant

21 Nov 2016 Evaluate

Panacea Biotec is currently trading at Rs. 110.00, up by 4.50 points or 4.27% from its previous closing of Rs. 105.50 on the BSE.

The scrip opened at Rs. 108.00 and has touched a high and low of Rs. 113.15 and Rs. 103.00 respectively. So far 22895 shares were traded on the counter.

The BSE group 'B' stock of face value Rs. 1 has touched a 52 week high of Rs. 171.20 on 04-Dec-2015 and a 52 week low of Rs. 83.90 on 12-Feb-2016.

Last one week high and low of the scrip stood at Rs. 113.45 and Rs. 103.00 respectively. The current market cap of the company is Rs. 655.38 crore.

The promoters holding in the company stood at 74.60%, while Institutions and Non-Institutions held 0.13% and 25.27% respectively.

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.

Panacea Biotec Share Price

344.65 -0.10 (-0.03%)
05-Dec-2025 16:59 View Price Chart
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