USFDA raises concern at Biocons facility
US Food and Drug Administration (USFDA) conducted a post-approval and GMP inspection at Biocon’s facility located in Bengaluru.
The inspection by the regulatory authority was conducted at Biocon’s small molecules of API manufacturing facility which is located in Biocon campus (Bengaluru). The inspection took place from February 20 to 26, 2020. The inspection concluded with the agency issuing Form 483 with two observations that are procedural in nature. Responding to this update, the company confidently addresses the observations with Corrective and Preventive Action Plan (CAPA), thereby, complying with global standards of quality and compliance.
Biocon Limited is a biopharmaceutical company focussing to reduce therapy costs of chronic diseases like autoimmune, diabetes and cancer. Through its products and research services, it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. Biocon has developed a range of novel biologics, biosimilars, differentiated small molecules and affordable recombinant human insulin and analogs.
On Thursday, the stock of the company was trading at Rs 299.20, up by 0.20 per cent or Rs 0.50 per share. The 52-week high is Rs 323.30 and 52-week low is Rs 211.30 on BSE.