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Mile Stone

2024

  • Zhunan Site Dedicated Oncology(Cytotoxic) Oteracil API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • ​Zhunan Site Dedicated Oncology(Cytotoxic) Tegafur API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • Polaris Group Announced the Acquisition of Genovior Biotech, Initiating Dual- Engine Growth​

2023

  • Zhunan Site Dedicated Biologic API Plant obtained PIC/S GMP Certification by Japan Client

  • Taiwan FDA granted the API Market License of Ponatinib HCI "GBC"

  • Taiwan FDA granted Market License of Valprocure Injection 100mg/ml  "GBC"

  • ​Taiwan FDA granted Market License of Octreo-T Injection 0.1mg/ml

  • Zhunan Site Dedicated Oncology(Cytotoxic) Aseptic Lyo Injectable Vial Commercial Plant obtained swissmedic GMP Certification.

  • Zhunan Site Peptide Synthesis Teriparatide API Plant obtained EU GMP(QPD).

  • ​Zhunan Site Dedicated Oncology(Cytotoxic) Pemetrexed API Plant obtained EU GMP(QPD).

  • Zhunan Site Dedicated Oncology(Cytotoxic) Bortezomib API Plant obtained EU GMP(QPD).

  • Zhunan Site Dedicated Oncology(Cytotoxic) Azacitidine API Plant obtained EU GMP(QPD).

  • ​Zhunan Site Dedicated Oncology(Cytotoxic) Ponatinib API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • BioSpectrum Asia granted GBC the Excellence Award "Top Company in API Development"!

  • ​Taiwan FDA granted the peptide API Market License of Teriparatide "GBC"

2022

  • ​Taiwan FDA granted Market License of Gemcitabine Lyo. Injection 200mg "GBC"

  • ​Taiwan FDA granted Market License of Levetiracetam Inj. 100mg/mL "GBC"

  • Taiwan FDA granted the peptide API Market License of Octreotider Acetate "GBC"

  • Taiwan FDA granted Market License of Doxorubicin Hydrochloride Lyophilized Inj. 10mg "GBC

  • Taiwan FDA granted Market License of Epirubicin Injection 2mg/mL "GBC

  • ​Taiwan FDA granted Market License of Irinotecan Injection 20mg/mL "GBC"

  • Taiwan FDA granted Market License of Docetaxel Injection 20mg/mL "GBC"

  • ​Zhunan Site Dedicated  Peptide Synthesis Octreotide API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • Taiwan FDA granted Market License of "GBC" Teicoplanin Inj. 200mg

  • ​​​Zhunan Site API Plant obtained TFDA PIC/S GDP Certification for Supplying and Holding for APIs (with cold chain).

  • Taiwan FDA granted Market License of Azacitidine Lyophilized Inj 100mg "GBC"

  • Taiwan FDA granted Market License of Gancicure Lyo Inj. 500mg "GBC"

2021

  • Tainan Site Aseptic Sol. Injectable Vial Commercial Plant obtained TFDA PIC/S GMP Certification.

  • Tainan Site Aseptic Pre-Filled Syringe Commercial Plant obtained TFDA PIC/S GMP Certification.

  • Taiwan FDA granted Market License of Fulvestrant Lyophilized Injection 250mg "GBC"

  • ​Taiwan FDA granted the API Market License of Fulvestrant "GBC"

  • ​GBC obtained the qualification approval letter from the Bureau of Industry of the Ministry of Economic Affairs for "Entrusting Domestic Pharmaceutical R&D Service Companies for the Biotechnology and Pharmaceutical Industry" and was included in the referen

  • Zhunan Site Dedicated  Peptide Synthesis Teriparatide API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • Taiwan FDA granted Market License of Oxaliplatin Injection 5mg/mL "GBC"

  • Zhunan Site Dedicated Oncology(Cytotoxic) Fulvestrant API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • Zhunan Site Dedicated  Peptide Synthesis Glucagon API Plant obtained Taiwan FDA PIC/S GMP Certification.

  • Taiwan FDA granted Market License of Acyclovir Lyophilized Inj. 250mg "GBC"

  • Zhunan Site Dedicated Oncology(Cytotoxic) Aseptic Sol. Injectable Vial Commercial Plant obtained TFDA PIC/S GMP Certification.

  • Taiwan FDA granted Market License of Bortezomib for Injection 3.5mg "GBC"

  • Tainan Site Cartridge Pen obtained EU GMP(QPD).

  • Zhunan Site Biological Products obtained PMDA AFM Certification.

  • Taiwan FDA granted the API Market License of Azacitidine "GBC"

2020

  • Taiwan FDA granted the API Market License of Bortezomib "GBC"

  • Taiwan FDA granted Market License of Colistimethate Sodium Lyophilized Injection 2MIU "GBC"​​

  • Taiwan FDA granted Market License of Pemetrexed Lyophilized Inj. 500mg "GBC"​ 

  • Zhunan Site Dedicated Oncology(Cytotoxic) Aseptic Lyo Injectable Vial Commercial Plant obtained PIC/S GMP Certification by North America Client (SQA)

  • Zhunan Site Aseptic Lyo Injectable Plant obtained TFDA PIC/S GMP Certification.

  • Zhunan Site Dedicated Oncology(Cytotoxic) Aseptic Lyo Injectable Vial Commercial Plant obtained Phinippines FDA PIC/S GMP Certification.​​

  • "Industrial Development Bureau, Ministry of Economic Affairs” granted TDP (Technology Development Programs) of Teriparatide Cartridge Pen Injectable.

  • Taiwan FDA granted Market License of Pemetrexed Lyophilized Inj. 100mg "GBC"​

  • Zhunan Site Dedicated Oncology(Cytotoxic) Pemetrexed API Plant obtained TFDA PIC/S GMP Certification.

  • ​Taiwan FDA granted the API Market License of Pemetrexed Disodium Hemipentahydrate "GBC"

  • ​Tainan Site Aseptic Injectable Commercial Plant obtained PMDA AFM Certification.

  • ​​​Zhunan Site Commercial Plant obtained TFDA PIC/S GDP Certification for Supplying and Holding for medicinal products (with cold chain).

  • ​Zhunan Site Dedicated Oncology(Cytotoxic) Aseptic Lyo Injectable Vial Commercial Plant obtained TFDA PIC/S GMP Certification.

  • ​​Zhunan Site Dedicated Oncology(Cytotoxic) Bortezomib API Plant obtained TFDA PIC/S GMP Certification.

2019

  • Zhunan Site Dedicated Oncology(Cytotoxic) Azacitidine API Plant obtained EU GMP(QPD).

  • ​Tainan Site Commercial Plant obtained TFDA PIC/S GDP Certification for Supplying and Holding for medicinal products (with cold chain).

  • ​Tainan Site Aseptic Cartridge Pen Injectable Commercial Plant obtained TFDA PIC/S GMP Certification.

  • Tainan Site Aseptic Pre-Filled Syringe Commercial Plant obtained TFDA PIC/S GMP Certification.

  • Tainan Site Aseptic Lyo. Injectable Vial Commercial Plant obtained TFDA PIC/S GMP Certification.

  • Tainan Site Aseptic Sol. Injectable Vial Commercial Plant obtained TFDA PIC/S GMP Certification.

  • ​Zhunan Site Dedicated Oncology(Cytotoxic) Azacitidine API Plant obtained TFDA PIC/S GMP Certification.

2018

  • GBC obtained TTQS Certification from Ministry of Labor.

  • Zhunan Site Aseptic Lyo Injectable Plant obtained TFDA PIC/S GMP IMP Certification.

  • ​Zhunan Site Monoclonal Antibody R&D Lab Completed

2017

  • Tainan Site Cartridge /Pen Injector Line Completed

  • Tainan Site Pre-Filled Syringe Line Completed

  • Tainan Site Sterile Injectable Plant Completed

  • Zhunan Site Injectable Pilot Plant, Lyophilization Vial Line and Pre-Filled Syringe Line Completed

  • Zhunan Site Peptide Pilot Plant Completed

  • Zhunan Site Dedicated Oncology Plant (API & Lyophilization Vial Line) Completed

2016

  • Zhunan Site Microbial Pilot Plant and  Small-scale injectable plant completed

  • Zhunan Site Analytical/ Formulation/ Bio Process Development/ Synthesis Lab completed

2015

  • The 16th Park Investment Supervisory Committee approved the establishment of Genovior Biotech

  • HQ established​