Pharma major Biocon announced on Monday that United States Food and Drug Administration (USFDA) has classified Biocon Biologics’ Biocon Park Site in Bengaluru as Voluntary Action Indicated (VAI).
According to the company’s statement, this is related to the combined current good manufacturing practices (cGMP) inspection and Pre-Licensing Inspection (PLI) conducted by the USFDA 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,” the company spokesperson said in a statement.
Following the development, Biocon’s share price rose up to 9.18 per cent to hit an intra-day high of Rs 350.80 per share on Monday.