Biocon declined 2.11% to Rs 288.25 after the US drug regulator issued a Form 483 with five observations for the company's API manufacturing facility.
The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) and Good Manufacturing Practice (GMP) inspection of the Active Pharmaceutical Ingredient (API) manufacturing facility of Biocon.At the conclusion of the inspection of the Bengaluru facility, which took place between 20 and 24 January 2020, the agency issued a Form 483, with five observations.
Biocon will respond to the FDA with a corrective and preventive action plan (CAPA) and is confident of addressing these observations expeditiously. The firm said it remains committed to global standards of quality and compliance. The announcement was made before trading hours on Monday, 24 January 2020.
Biocon reported Q3 numbers on 23 January 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.
Biocon is an innovation-led global biopharmaceuticals company.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
