This site is intended for Healthcare professionals only.

Panacea Biotec Announces Receipt of Establishment Inspection Report from USFDA


Panacea Biotec Announces Receipt of Establishment Inspection Report from USFDA

Panacea Biotec Ltd. has announced the receipt of Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and pre-approval inspection conducted by USFDA, at the company’s oncology parenteral and oral solids dosage formulation facilities at Malpur, Baddi, District Solan, Himachal Pradesh, India.

The company 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 sites 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.

Shares of PANACEA BIOTEC LTD. was last trading in BSE at Rs.109 as compared to the previous close of Rs. 108.95. The total number of shares traded during the day was 1711 in over 54 trades.

The stock hit an intraday high of Rs. 109.4 and intraday low of 108.1. The net turnover during the day was Rs. 186295.



Source: Reuters
0 comment(s) on Panacea Biotec Announces Receipt of Establishment Inspection Report from USFDA

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted