Biocon spurts after USFDA concludes inspection of insulin unit in Malaysia

Biocon rose 2.73% to Rs 278 after the company said its insulins manufacturing facility in Malaysia received the Establishment Inspection Report (EIR) from the US drug regulator.

Biocon Sdn Bhd, a subsidiary of Biocon, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the Pre-Approval Inspection (PAI) of its insulins manufacturing facility in Malaysia, for insulin Glargine. The inspection was conducted between 10 and 21 February 2020.

The inspection has been closed with a 'VAI' (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in February 2020. This is an endorsement of our commitment to global standards of quality and compliance.

Biocon said the closing of the USFDA inspection of the Malaysia facility is an important milestone in the company's journey of developing insulin Glargine for patients in the US.

The company's insulin Glargine (Semglee) application filed by partner Mylan, with the USFDA, is currently under review. The announcement was made before trading hours today, 1 April 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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