Biocon shares fell 1.49 % to Rs 294.24 on the BSE after observations have been issued by the US regulatory authority for its API facility in Bengaluru.The USA Meals and Drug Administration (USFDA) issued a Type 483 with two observations to Biocon’ Bengaluru API facility.
Biocon stated that the observations are procedural in nature.
“On the conclusion of the inspection the company issued a Type 483, with two observations, that are procedural in nature,” Biocon stated in a regulatory submitting on Thursday.
The US drug regulator carried out a post-approval and GMP inspection of Biocon’s small molecules API manufacturing facility in Bengaluru between February 20 and 26, 2020.
The corporate stated that they’re assured of addressing it expeditiously and would reply to the drug regulator with a corrective and preventive motion plan in a well timed method.
“We stay dedicated to world requirements of high quality and compliance,” the corporate’s spokesperson stated within the assertion.
Earlier USFDA issued 5 observations to Biocon’s one other facility after the drug regulatory authority carried out a Pre-Approval Inspection (PAI) and GMP inspection of Biocon’s API manufacturing facility in Bengaluru from January 20 to January 24.
0 Comments