Biocon shares were down 2 percent to Rs 258.50 at 9.27am on Monday after the company received six observations from the US Food and Drug Administration (USFDA).The US FDA conducted two cGMP inspections at Biocon Sdn. Bhd’s insulins manufacturing facility in Malaysia, encompassing biologics drug substance, drug product units and quality control laboratories, as well as the delivery devices unit.These inspections were conducted between July 10 and 20. The agency has issued Form 483 with six observations for drug substance, drug product units and quality control laboratories as well as 2 observations for the delivery devices unit.We will submit a Corrective and Preventive Action (CAPA) plan to the USFDA in a timely manner and are confident of addressing these observations expeditiously. Biocon Biologics remains committed to global standards of quality and compliance, it addedThe meeting of the board of directors of the company is scheduled on August 10 to approve and take on record the un-audited standalone and consolidated financial results for the quarter ended June 30, 2023, amongst other routine matters.Subsidiary Biocon Biologics announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar.The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023.

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