Company Statement

June-23
03-June	Biocon Pharma Limited’s facility at Bengaluru Concludes USFDA Surveillance and Inspection, With Zero Observations
May-23
20-May	Biocon’s API facility at Hyderabad Concludes USFDA Inspection, with Zero Observations
April-23
28-Apr	Biocon Biologics’ New mAbs Facility Receives EU GMP Certification for bBevacizumab

February-23
12-Feb	USFDA issues a CRL for the Biologics License Application for Bevacizumab
January-23
07-Jan	USFDA issues a CRL for the Biologics License Application for Insulin-R
December-22
22-Dec	Biocon Limited receives the final inspection report from EDQM
October-22
21-Oct	Biocon Biologics Insulins Facility in Malaysia Receives EU GMP Certification
07-Oct	Biocon Foundation Receives ‘Mahatma Award 2022 for Excellence in Social Good’
August-22
31-Aug	USFDA Consolidated Biocon Biologics Notification
July-22
05-July	Biocon Biologics Receives EU GMP Certification for Its New Biologics Manufacturing Facility in Bengaluru
June-22
21-June	Biocon Biologics issues a statement in response to the media reports related to bribery allegations
May-22
03-May	HPRA Completes Audit of Biocon Biologics New mAbs Drug Substance Facility in Bengaluru

January-22
08-Jan	The USFDA issues a complete response letter for the Biologics License Application (BLA) for insulin Aspart
September-21
25-Sep	Biocon Biologics Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection
08-Sep	Biocon Limited enters into a settlement agreement with Celgene Corp.

28-Apr	Kiran Mazumdar-Shaw Joins Board of Trustees of Memorial Sloan Kettering Cancer Center, U.S.
26-Apr	Biocon Biologics and Viatris Receive European Commission Approval for Biosimilar Bevacizumab
12-Apr	Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, receives GMP compliance certificate from MHRA, UK
Feb-21
12-Feb	Biocon Biologics and Viatris Receive European Commission Approval for Kixelle, Biosimilar Insulin Aspart
Dec-20
25-Dec	Biocon Biologics Statement on the Status of Bevacizumab FDA Action Date in Dec 2020
14-Dec	Biocon Biologics and Mylan Receive CHMP Recommendation for Approval of Biosimilar Insulin Aspart
May-20
12-May	Biocon Biologics Drug Substance Facilities in Bengaluru Receive EU GMP Certification
08-May	Biocon’s Receives EIR for Small Molecules API Manufacturing Facility for Pre -Approval and GMP U.S. FDA Inspection
Apr-20
16-Apr	Biocon Biologics Receives EIR from U.S. FDA for Two Manufacturing Facilities, Inspection Stands Closed