【Intro】FORMOSA LABORATORIES,INC.

撰文新聞中心
日期2021-07-15
FORMOSA LABORATORIES,INC.

Company Introduction

台耀化學於1995年成立,並於2000年踏入原料藥生產的領域。挾其強大的研發實力及厚實的品質系統管理,逐漸在生技製藥業展露頭角。目前有數十項原料藥產品行銷全球,同時提供CDMO (Contract Development and Manufacturing Organization)服務與抗體耦合藥物(Antibody-Drug conjugates (ADCs))開發製造服務。2018年台耀跨足針劑領域,提供細胞毒性及非細胞毒性之無菌針劑充填及凍乾針劑藥品一站式的垂直整合開發製造服務。
台耀位於桃園市蘆竹區,擁有員工人數八百多人,占地45,508平方公尺,擁有ISO認證,且成功通過台灣衛生福利部食品藥物管理署,美國FDA,德國BGV,歐盟EDQM 及日本PMDA等GMP查廠認證。本公司在cGMP規範要求下,不斷的更新並落實產品符合國際現行優良製造規範標準,行銷原料藥產品、針劑藥品及代工業務深入至歐美日各地與全世界。

Formosa Laboratories offers full-service GMP manufacturing from drug substance to drug product.  Our injectable facility accommodates both small molecules and biologics, from pilot scale to commercial scale, and all under general or cytotoxic control.  Combining this expertise, our platform for Antibody-Drug Conjugate manufacturing is well established. Our service scope includes antibody production (through domestic alliance), to in-house toxin-linker CMC services and antibody bioconjugation, and finally through to cytotoxic fill-finish drug product manufacturing. Formosa Laboratories is fully GMP compliant and has been approved by DOH of Taiwan, US FDA, BGV of Germany, EDQM, and PMDA of Japan.

Brief description of main products or services 

Product & Service

Formosa Laboratories provide the high quality active pharmaceutical ingredients globally. We are one of the leading manufacturers of active pharmaceutical ingredients in the world.

Formosa Laboratories also offers full-service for both general and HPAPI for all stages of drug development for both clinical trial material and commercialized. Formosa Laboratories provides one-stop solution for ADCs manufacturing from antibody production through domestic alliance, to in-house toxin-linker CMC services and antibody bioconjugation for drug substance, and finally through to cytotoxic fill-finish drug product manufacturing.

We provide one-stop solutions for sterile injectable drug products to our customers. Our state-of-the-art injectable manufacturing facility and team of dedicated experts are capable to provide services from contract development to commercial manufacturing.
Formosa Laboratories have below strengths and offer the services of one-stop service to customer.
  • General, Cytotoxic, and High potency drugs
  • Liquid-filled, Lyophilized and Pre-filled syringe products
  • Pilot scale to Commercial scale capacity

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