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Biocon Biologics
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News
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Company Statements
COMPANY STATEMENTS
2022
2021
2020
2019
2018
2022
Biocon Biologics Consolidated Statement on USFDA Inspections
Aug 31, 2022
Biocon Statement on Parts of the Charge Sheet Leaked to a Media Outlet
Aug 25, 2022
Biocon Biologics Receives EU GMP Certification for Its New Biologics Manufacturing Facility in Bengaluru
Jul 5, 2022
Biocon Biologics issues a statement in response to the media reports related to bribery allegations
Jun 21, 2022
Biocon Biologics Denies Bribery Allegations
Jun 21, 2022
The USFDA issues a complete response letter for the Biologics License Application (BLA) for insulin Aspart
Jan 7, 2022
2021
Biocon Biologics Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection
Sep 25, 2021
Kiran Mazumdar-Shaw Joins Board of Trustees of Memorial Sloan Kettering Cancer Center, U.S.
Apr 28, 2021
Biocon Biologics and Viatris Receive European Commission Approval for Biosimilar Bevacizumab
Apr 26, 2021
Biocon Biologics and Viatris Receive European Commission Approval for Kixelle, Biosimilar Insulin Aspart
Feb 12, 2021
2020
Biocon Biologics Statement on the Status of Bevacizumab FDA Action Date in Dec 2020
Dec 25, 2020
Biocon Biologics and Mylan Receive CHMP Recommendation for Approval of Biosimilar Insulin Aspart
Dec 14, 2020
Biocon Biologics Drug Substance Facilities in Bengaluru Receive EU GMP Certification
May 12, 2020
Biocon Biologics Receives EIR from U.S. FDA for Two Manufacturing Facilities, Inspection Stands Closed
Apr 16, 2020
Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed
Apr 1, 2020
Biocon’s Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection
Feb 22, 2020
2019
U.S. FDA Completes Pre-Approval Inspection of Two New Biocon Biologics Facilities in Bengaluru
Sep 20, 2019
U.S. FDA Issues Complete Response Letter for New Drug Application for Insulin Glargine; Commercialization Plans Remain Unchanged
Aug 31, 2019
U.S. FDA completes surveillance (routine) cGMP inspection of one of our Biologics Drug Product facilities in Bengaluru
Aug 31, 2019
Pre-Approval U.S. FDA Inspection Conducted at Biocon’s Insulins Facilities in Malaysia
Jul 8, 2019
Biocon Biologics Facilities in Bengaluru Receive EU GMP Certification
Jun 14, 2019
Biocon Facility Completes Pre Approval U.S. FDA Inspection
Mar 6, 2019
2018
Biosimilar Trastuzumab Co-Developed by Biocon Receives Approval in the EU
Dec 19, 2018
Biosimilar Pegfilgrastim Co-Developed by Biocon Receives Approval in EU
Nov 30, 2018
Biocon Update on Insulin Glargine
Jun 2, 2018
Mylan and Biocon seek to accelerate introduction of Adalimumab biosimilar in EU
Apr 11, 2018
Update on Company Statement on US-FDA Inspection at Biocon Malaysia
Mar 13, 2018
Company Statement on US-FDA Inspection at Biocon Malaysia
Feb 21, 2018
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