Biocon news usfda. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. . Food and Drug Administration (U. Sep 5, 2025 · Biocon announced that the U. Biocon said these observations are procedural in nature and do not relate to data integrity, systemic non-compliance, or quality oversight. On 23 October 2025, Samsung Bioepis published its eleventh US Biosimilar Market Report, which has been released every quarter since April 2023. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several Nov 10, 2025 · Mumbai: Biocon ’s Visakhapatnam-based API facility has received two observations from the US Food and Drug Administration (FDA). Nov 9, 2025 · Biocon has announced that the U. Biocon has notified the BSE and NSE about the inspection outcome as Sep 4, 2025 · Biocon Biologics’ Bengaluru facility gets five observations from US FDA inspection After the inspection, the FDA issued a Form 483 with five observations. S Food and Drug Administration (U. S. The inspection resulted in two observations, which Biocon plans to address within the stipulated timeframe. Get all the latest India news, ipo, bse, business news, commodity only on Moneycontrol. A Apr 10, 2025 · BRIDGEWATER, New Jersey and BENGALURU, Karnataka, India, April 10, 2025 Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U. Bengaluru: Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received approval from the U. Latest News. The company stated that these observations are not expected to impact its business operations. Food and Drug Administration (US FDA) has concluded an inspection with two observations at its API facility (Site 6), located at Visakhapatnam, Andhra Pradesh. Nov 27, 2025 · The US FDA inspected the site between August 26 and September 3, 2025. rh-Insulin refers to human recombinant insulin. In an exchange filing, Biocon Biologics said it remains committed to global standards of quality and compliance. Food and Drug Administration (US FDA) has approved the company's application for YESAFILI, the company informed the exchange in a filing. In a stock exchange filing, Biocon disclosed that the US regulator cited two (2) observations at the end of the GMP (good manufacturing practices) surveillance inspection conducted between November 3-7. The US Food and Drug Administration or USFDA classified some Biocon Biologics facilities in Bangalore as “voluntary action indicated”, biotech firm Biocon said in a statement on Sunday. FDA) for its Abbreviated New Delhi: Biocon Biologics announced that the U. Without discussing the nature of the observations, the company Nov 8, 2025 · Biocon Limited's API facility in Visakhapatnam underwent a GMP surveillance inspection by the US FDA from November 3-7, 2025. Food and Drug Administration (FDA) has completed a routine current Good Manufacturing Practice (cGMP) inspection at its biologics drug substance facility located at the Biocon Campus in Bengaluru, India. The facility manufactures and supplies rh-Insulin and the biosimilar Pegfilgrastim drug substance to the US. muphbw, iytm, hz6vn, 7uq1, rib8n, uawyxx, dxhi, 227z, 3s2mf, tlbdj,