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COMPANY STATEMENTS

2024

Biocon Receive Decentralized Procedure Approval for Liraglutide in European Union
Dec 24, 2024
EMA’s CHMP recommends approval of Biocon Biologics’ YESINTEK®, biosimilar to J&J’s Stelara®
Dec 15, 2024
Biocon Receives EIR with VAI Status from US FDA for Bengaluru API Facility Site-2
Dec 07, 2024
U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J's Stelara® (Ustekinumab)
Dec 01, 2024
USFDA Classifies Biocon Biologics’ Biocon Park Site in Bengaluru, India as Voluntary Action Initiated (VAI)
Nov 10, 2024
Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI)
Oct 30, 2024
US FDA Completes Inspection at Biocon Biologics’ Insulins Facility at Johor Bahru, Malaysia
Sep 28, 2024
Company Statement on Site 2 – API facility, Bengaluru
Sep 28, 2024
Company Statement on Site 1 – API facility, Bengaluru
Sep 22, 2024
Biocon Pharma Limited Receives US FDA Approval for Sacubitril/Valsartan Tablets
Sep 01, 2024
Biocon Pharma Limited Receives US FDA Approval for Daptomycin Injection ANDA
Aug 30, 2024
Biocon Receives EIR from US FDA for Visakhapatnam API Facility
Aug 30, 2024
Biocon Receives USFDA Establishment Inspection Report with Voluntary Action Indicated for Visakhapatnam Facility
Aug 05, 2024
US FDA Completes Inspection at Biocon Biologics’ Facilities at Biocon Park, Bengaluru, India
July 27, 2024
EMA Approves Biocon Biologics’ New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites
June 24, 2024
Company Statement on Site 5 – API facility, Visakhapatnam
June 22, 2024
Company Statement on Site 6 – API facility, Visakhapatnam
Jun 15, 2024
Biocon Receives Approval for Antifungal Medication, Micafungin from US FDA
Jun 03, 2024
Biocon receives approval for Tacrolimus capsules from SAHPRA
Apr 20, 2024
Biocon’s Liraglutide (gSaxenda®) Receive Approval from MHRA
Apr 01, 2024
Biocon Biologics Secures Canada Market Entry Date for YESAFILI®, a Proposed Biosimilar to EYLEA®
Mar 04, 2024
Company Statement on rh-Insulin for Veterinary use
Feb 29, 2024
Company Statement on bBevacizumab
Feb 09, 2024
Biocon Receives Tentative Approval for Dasatinib from the US FDA
Feb 06, 2024

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