Biocon gets EIR from USFDA for its small particles API Unit in Bengaluru Kumar Jeetendra | May 8, 2020 Biocon has gotten the Establishment Inspection Report (EIR) from the U. S. Food and Drug Administration (FDA) for the Pre-Approval and GMP examination of its Small Molecules API Manufacturing Facility at Biocon Park SEZ, Bommansandra, Bengaluru, led between 20 January and 24 January 2020. At the finish of the review the office had given a Form …
Biocon, Mylan get USFDA endorsement for the dispatch of their insulin glargine infusion Kumar Jeetendra | June 13, 2020 Biocon Ltd and Mylan NV on Friday reported that they have gotten endorsement from the United States Food and Drug Administration (FDA) for the dispatch of its insulin glargine infusion Semglee which is intended to control high glucose in grown-ups with diabetes “The US FDA has affirmed the New Drug Application (NDA) for Semglee (insulin …