Biocon Small Molecules API Manufacturing Facility Completes Post -Approval and GMP USFDA Inspection

New Delhi: Drug API maker, Biocon has informed that the U.S. Food and Drug Administration (FDA) conducted a Post-Approval and GMP inspection of Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru, between Feb 20 and Feb 26, 2020.

At the conclusion of the inspection, the agency issued a Form 483, with two observations, which are procedural in nature. We are confident of addressing these observations expeditiously and will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) in a timely manner.

This information is also provided to BSE Limited & National Stock Exchange of India Limited 

Biocon Limited is an Indian biopharmaceutical company based in Bangalore, India.The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe.It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets [provide reference]. In research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon.

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Biocon's formulations for the Indian market include Metabolics, Oncology, Immunotherapy, Nephrology and Specialty. Some of Biocon's key brands in India include INSUGEN (rh-insulin), BASALOG (Glargine), BIOMAb EGFR (Nimotuzumab), BLISTO (Glimepiride + Metformin), CANMAb (Trastuzumab), Evertor (Everolimus), TACROGRAF (Tacrolimus), ALZUMAb(Itolizumab) and KRABEVA (Bevacizumab).

Medical Dialogues previously reported that the USFDA inspection at its Insulin Manufacturing Facility in Malaysia, and that the agency issued a Form 483 with 3 observations which we believe are procedural in nature.On February 22, 2020, Biocon's Insulin Manufacturing Facility in Malaysia Completes US FDA (PAI) Inspection.

Read also: Biocon's Insulin Manufacturing Facility in Malaysia Completes USFDA inspection with three observations