The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) of insulins manufacturing facility of Biocon’s Malaysian subsidiary for insulin Glargine, between 10 and 21 February 2020.
At the conclusion of the inspection, the agency issued a Form 483 with three observations. Biocon said it believes that the observations are procedural in nature. It will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and is confident of addressing these observations expeditiously.
The FDA has set a target action date for our Insulin Glargine application in June 2020.
We believe the outcome of this inspection does not in any way impact the commercialization plans of insulin glargine in the US. Biocon Biologics is committed to global standards of quality and compliance, the company spokesperson said.
Shares of Biocon were currently up 2.54% at Rs 323. It fell 3.74% to hit the day’s low at Rs 303.20.
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.