Biocon says Bengaluru API unit gets EIR from USFDA

Biocon on Friday (20 March 2020) said its Bengaluru facility received establishment inspection report from the US drug regulator.

Biocon announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the post-approval and Good Manufacturing Practice (GMP) inspection of its small molecules API (active pharmaceutical ingredient) manufacturing facility at Bengaluru, conducted between 20 and 26 February 2020. The EIR has been closed with a 'VAI' classification for the observations. At the conclusion of the inspection last month the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company.

Shares of Biocon advanced 1.62% to Rs 256.40. The stock has fallen 20.69% from its 52-week high of Rs 323.30 hit on 24 February 2020.

On a consolidated basis, net profit fell 6.6% to Rs 202.80 crore in Q3 December 2019 (Q3 FY20) from Rs 217.20 crore in Q3 December 2018 (Q3 FY19), due to higher R&D expenses and tax impact of an exceptional item. Profit before tax (PBT) stood at Rs 315.10 in Q3 FY20, up by 8.9% from Rs 289.30 crore in Q3 FY19. Net sales rose 13.5% year-on-year (Y-o-Y) to Rs 1,748.10 crore in Q3 December 2019 over Q3 December 2018.

Biocon is an innovation-led global bio-pharmaceuticals company.

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