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Brief Introduction
Brief Introduction
The facility is a PIC/S GMP-certified API plant accredited by the Taiwan Food and Drug Administration (TFDA). Supported by ITRI’s professional and customized technical capabilities, it provides clinical-trial-grade drug substances, accelerates new drug pilot production and analytical method development, and offers regulatory science and PIC/S GMP audit consulting services to assist with new product verification and compliance.
2023: Received TFDA PIC/S GDP certification.
2020: Received TFDA PIC/S GMP certification.
2001: Completed equipment installation, validation, and initiated trial production.
1997: Established the API cGMP pilot plant for pilot-scale API production.
Scope of Services
Scope of Services
GXP One-Stop Service Platform:
Drug synthesis development and pilot-scale manufacturing
Analytical technology platform services
GXP software/hardware system implementation and compliance consulting
Core Facilities
Core Facilities
10–500 L jacketed reaction vessels
Class B, C, and D cleanrooms
Aseptic processing area
GMP-compliant quality control laboratory
Biosafety Level 2 (P2) laboratory
Info
Info
林明濬 博士
+886-3-5743987
FoxLin@itri.org.tw
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