Biocon in the news

Biocon is buzzing today morning; from its close of Rs.321.25, the stock opened slightly higher at Rs.326 and rose to an intraday high at Rs.338.60, up over 5.5%. Its 52-week high is at Rs.395.65.

The stock is up, reacting to its news of yesterday that the US FDA has classified Biocon Biologics’ facilities at Biocon Park, Bengaluru, India, as Voluntary Action Indicated (VAI).

This relates to the combined cGMP inspection and Pre-Licensing Inspection (PLI) conducted by the agency between July 15 – 26, 2024. The inspection scope had included six (6) separate Biologics manufacturing units comprising of four (4) Drug Substance and two (2) Drug Product manufacturing plants as well as five (5) Analytical Quality Control Laboratories, four (4) Microbiology Laboratories, and two (2) Warehouses.

VIA means objectionable conditions or practices were found, but the FDA is not prepared to take or recommend any administrative or regulatory action. This is the second-best classification that a plant can get from the USFDA; the first being No Action Indicated.