Biocons facility receives five observations
Biocon announced that US Food and Drug Administration (USFDA) conducted Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) at the company’s API manufacturing facility located in Bengaluru (Karnataka).
The inspection which took place during January 20-24, 2020 by USFDA at the company’s facility concluded with agency issuing Form 483 with five observations. Biocon stated in the press release that it will respond to the agency with appropriate Corrective and Preventive Action Plan (CAPA) in place, which will confidently address the raised concerns and enable the company to remain committed to global quality and compliance standards.
Biocon Limited is an innovation-led global biopharmaceuticals company, committed to an enhanced affordable access to complex therapies for chronic conditions, such as diabetes, cancer and autoimmune.
On Monday, the shares of Biocon Limited were trading at Rs 291.30, down by 1.07 per cent or Rs 3.15 per share. The intraday high is Rs 297.80 and intraday low is Rs 286.15. The 52-week high is Rs 341.43 and 52-week low is Rs 211.30 on BSE.