Biocon EIR closed with a VAI classification

On Friday, Biocon announced that the  EIR issued by the United States Food & Drug Administration (USFDA) for its small molecules API manufacturing facility at Biocon Park SEZ, Bommasandra (Bengaluru, Karnataka) has been closed with a VAI classification. 

The agency had conducted pre-approval and GMP inspection of its small molecules API manufacturing facility at Biocon Park SEZ, Bengaluru between January 20 and 24, 2020. At the conclusion of the inspection, the agency had issued a form 483, with five observations, which are currently being addressed by the company. The EIR has been closed with a VAI classification for the observations.

Form 483 is issued at the completion of the inspection when inspectors have perceived any conditions in their judgement which may constitute a violation of the Food Drug & Cosmetic Act and related acts. 

Biocon Limited is a biopharmaceutical company focussed on reducing therapy costs of chronic diseases like autoimmune, diabetes and cancer.

At 2.50 pm on Friday, the stock was trading at Rs 357.25, up by 2.17 per cent or Rs 7.60 per share. The 52-week high is recorded at Rs 367.80 and the 52-week low is Rs 211.30 on BSE.