ABOUT US

Mile Stone

2022

  • 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 PIC/S 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 PIC/S 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​