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Total Articles : 4

Health Canada Approves Biocon and Mylan’s Ogivri™, the First Trastuzumab Biosimilar, for the Treatment of HER2-Positive Breast and Gastric Cancers

BENGALURU, India and HERTFORDSHIRE, England/PITTSBURGH – May 22, 2019 Biocon Ltd. and Mylan N.V. today announced that Health Canada has approved Mylan’s Ogivri™ (trastuzumab), a biosimilar to Herceptin1 (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer  →
0 Views : 67

Biocon Biologics Facilities in Bengaluru Receive EU GMP Certification

Bengaluru, India, June 14, 2019 “Biocon has received the Certificate of GMP compliance from EMA for its Biologics Drug Product (DP) as well as Drug Substance (DS) facilities at Biocon Park, Bengaluru. These facilities, used for the manufacture of Biocon’s  →
0 Views : 63

Biocon’s Sterile Drug Product facility Receives EIR from U.S. FDA

Bengaluru, India, June 23, 2018 “The Company confirms that Biocon has received an Establishment Inspection Report (EIR) from the USFDA for its Sterile Drug Product manufacturing facility in Bangalore, following the USFDA pre-approval inspection of this facility in April/ May  →
0 Views : 310

Biocon Regulatory Audit Update

May 02, 2018 “The US-FDA has completed a pre-approval inspection of our sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations. The observations are largely procedural and aimed at continuous improvement. We  →
0 Views : 217

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