Biocon fell 1.10% to Rs 295.40 after the US drug regulator issued a Form 483 with two observations to the company's API manufacturing facility in Bengaluru.
The US Food and Drug Administration (FDA) conducted a post-approval and good manufacturing practice (GMP) inspection of Biocon's small molecules Active Pharmaceutical Ingredient (API) manufacturing facility at Bengaluru between 20-26 February 2020. At the conclusion of the inspection, the agency issued a Form 483, with two observations, which are procedural in nature.Biocon said it is confident of addressing these observations expeditiously and will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) in a timely manner. Biocon made the announcement before trading hours today, 27 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.
Biocon is an innovation-led global bio-pharmaceuticals company.
Shares of Biocon have declined 6.22% in four sessions from a recent closing high of Rs 315 reported on 20 February 2020.
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