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PRESS RELEASE

FY 2025-26

April-26
08-Apr Biocon Pharma Limited Receives U.S. FDA Approval for Dapagliflozin Tablets, 5 mg and 10 mg
March-26
12-Mar Biocon Pharma Limited Receives U.S. FDA Approval for Liraglutide Injection gVictoza®
January-26
28-Jan U.S. FDA Issues VAI Status for Biocon API Facility at Paravada, Andhra Pradesh
12-Jan Biocon Pharma Limited Receives U.S. FDA Approval for Everolimus Tablets for Oral Suspension
December-25
18-Dec U.S. FDA Issues EIR with VAI Status for Biocon Generics Inc Cranbury Facility
05-Dec Biocon Pharma Limited Secures U.S. FDA Tentative Approval for Carbidopa and Levodopa Extended-Release Capsules
Novermber-25
27-Nov Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI)
19-Nov Biocon Pharma Limited Receives U.S. FDA Approval for Tofacitinib Extended-Release Tablets
08-Nov Company Statement on Biocon’s Visakhapatnam API Facility (Site 6)
October-25
11-Oct Company Statement on Biocon’s Cranbury, New Jersey Manufacturing Site
07-Oct Biocon Pharma Limited Secures U.S. FDA Tentative Approval for Rifaximin Tablets in Partnership with Carnegie Pharmaceuticals
September-25
04-Sep U.S. FDA Completes Inspection at Biocon Biologics’ Facility at Biocon Campus, Bengaluru, India
August-25
26-Aug Biocon Pharma Limited Secures U.S. FDA Tentative Approval for Sitagliptin Tablets
July-25
23-July Biocon Biologics Launches Nepexto®, a Biosimilar to Enbrel® (Etanercept), in Australia
07-July Biocon Biologics Receives MHRA UK Approval for Vevzuo® and Evfraxy®, Denosumab Biosimilars
May-25
25-May Biocon Biologics Receives MHRA, UK Approval for YESINTEK®, Biosimilar Ustekinumab
22-May Malaysian MoH Awards Insulins Supply Contract Extension to Biocon Biologics
21-May Biocon Biologics and Yoshindo Expand Access to Ustekinumab Biosimilar in Japan
15-May Biocon Pharma Limted Receives U.S. FDA Approval for Rivaroxaban Tablets
April-25
26-April Biocon Biologics Receives Positive CHMP Opinions for Biosimilar Denosumab in Europe
10-April Biocon Pharma Limited Receives U.S. FDA Approval for ANDA of Everolimus Tablets

FY 2024-25

Mar-25
24-Mar Biocon Pharma Limited Receives U.S. FDA Approval for Norepinephrine Bitartrate Injection
04-Mar Biocon Pharma Limited Secures U.S. FDA Approvals for Lenalidomide and Dasatinib
Feb-25
18-Feb European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar
Jan-25
12-Jan U.S. FDA Classifies Biocon Biologics Site in Johor Bahru, Malaysia as Voluntary Action Indicated (VAI)
07-Jan Japan Health Authority (PMDA) Approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J’s Stelara®
02-Jan Biocon Pharma Limited Receives NMPA Approval for Tacrolimus Capsules in China
Dec-24
24-Dec Biocon Receive Decentralized Procedure Approval for Liraglutide in European Union
15-Dec EMA’s CHMP recommends approval of Biocon Biologics’ YESINTEK®, biosimilar to J&J’s Stelara®
01-Dec U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab)
Nov-24
10-Nov USFDA Classifies Biocon Biologics’ Biocon Park Site in Bengaluru, India as Voluntary Action Initiated (VAI)
Oct-24
30-Oct Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI)
Sep-24
28-Sep US FDA Completes Inspection at Biocon Biologics’ Insulins Facility at Johor Bahru, Malaysia
28-Sep Company Statement on Site 2 – API facility, Bengaluru
22-Sep Company Statement on Site 1 – API facility, Bengaluru
01-Sep Biocon Pharma Limited Receives US FDA Approval for Sacubitril/Valsartan Tablets
Aug-24
30-Aug Biocon Pharma Limited Receives US FDA Approval for Daptomycin Injection ANDA
30-Aug Biocon Receives EIR from US FDA for Visakhapatnam API Facility Following Successful Inspection
05-Aug Biocon Receives USFDA Establishment Inspection Report with Voluntary Action Indicated for Visakhapatnam Facility
July-24
27-July US FDA Completes Inspection at Biocon Biologics’ Facilities at Biocon Park, Bengaluru, India
June-24
24-June EMA Approves Biocon Biologics’ New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites
15-June Company Statement on Site 6 – API facility, Visakhapatnam
03-June Biocon Receives Approval for Antifungal Medication, Micafungin from US FDA
April-24
20-April Biocon receives approval for Tacrolimus capsules from SAHPRA
01-April Biocon’s Liraglutide (gSaxenda®) Receive Approval from MHRA
ARCHIVES

FY: From April 1 – March 31

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