The US Food and Drug Administration has issued a Form 483 with five observations for Biocon's API Manufacturing facility.\n\n\n\nForm 483 observations are issued when US FDA inspectors notice shortcomings in a company's manufacturing processes, data storage and so on during an inspection.\n\n\n\nThe company has to address the issues raised in the Form 483 within a stipulated time.\n\n\n\nIn this case, said Biocon, the inspection was conducted as a pre-approval formality. Pre-approval inspections are conducted by the US FDA when a company seeks permission to export medicines or chemicals to the US.\n\n\n\nThe US FDA will give permission to market the drug only after the company addresses the shortcomings highlighted in the form.\n\n\n\nAPIs or active pharmaceutical ingredients are the core molecules used in a medicine or drug. Biocon has more than one facility to manufacture APIs, and the company did not clarify which facility was subjected to the inspection last week.\n\n\n\n"We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously," Biocon said in a statement.\n\n\n\nBiocon is among the most prestigious pharma companies in India.\n\n\n\nIt manufactures generic active pharmaceutical ingredients (APIs) that\n are sold in the developed markets of the United States and Europe.\n\n\n\nIt also manufactures biosimilar insulins, which are sold in India as \nbranded formulations and in both bulk and formulation forms. \n\n\n\nIt is one of the few Indian pharma companies that are present in the research space in a strong way. \n\n\n\nLocated with R&D in Bangalore and API unit in Hyderabad, India, Biocon has two subsidiaries\u2014 Syngene and Clinigene. \n\n\n\nBiocon\u2019s presence straddles four main therapeutic areas\u2014Diabetology, Cardiology, Nephrology and Oncology.\n\n\n\nSyngene International is engaged drug discovery while Clinigene International is in the clinical development space.