Shares of Biocon gained over 8 per cent after the US Food and Drug Administration (USFDA) classified its Bengaluru unit as voluntary action indicated (VAI)
The USFDA conducted an inspection focused on current Good Manufacturing Practices and a Pre-Licence Inspection (PLI) for a company’s facilities. This PLI aims to ensure that new biological products meet regulatory standards before obtaining a licence.
According to the company’s stock exchange filing, the inspection took place from July 15 to July 26, 2024. The scope of the inspection covered six distinct biological units, including four drug substance manufacturing facilities and two drug product manufacturing plants
It also comprised five analytical quality control laboratories, four microbiology laboratories and two warehouse.
Shares of Biocon closed at ₹348.85, up 8.59 per cent on BSE.