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JenKem Technology Co., Ltd.

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会社概要

  • 正式社名: JenKem Technology Co., Ltd.
  • 国際名称: 北京键凯科技股份有限公司 (JenKem Technology Co., Ltd.), Beijing, China
  • ブランド名 / 商号: JenKem
  • 登録国: China
  • 住所: China Mainland Tianjin Tianjin No. 9, Kangcheng Street, West District, Economic and Technological Development Zone, Dongli District, Tianjin • Beijing
説明:

JenKem Technology, established in 2001 in Tianjin and listed on the Shanghai Stock Exchange STAR Market since 2020 (688356.SH), develops and manufactures high-purity, low-polydispersity PEG and PEG co-polymer derivatives in batch sizes from 1 gram to over 40 kilograms under ISO9001 and ISO13485-certified quality systems following ICH Q7 GMP guidelines, alongside controlled manufacture of raw polyethylene glycol polymers with more than 10 metric tons of annual capacity. The company holds 86 approved patents (as of 2021) with 43 further pending, has filed multiple US and China DMFs for its PEG products, and operates a dedicated Innovation Research Institute (established 2019) supporting continued PEGylation technology development. Manufacturing active pharmaceutical ingredients and finished dosage forms, the company offers CRO and CDMO services to markets across North America, Central/South America, Western and Eastern Europe, Australasia, Asia, the Middle East, and Africa, trading on brand strength, international certification, and an experienced R&D team.

事業活動

賦形剤・添加剤

製造業者

バイオ医薬品サービス

サプライヤー

医薬用化学品

輸出業者製造業者

実験室用化学品・溶剤・標準物質

製造業者

原薬(API)

製造業者

完成医薬品(製剤)

製造業者
販売市場
主要製品/サービス

当社の製品・サービス

Sell · Laboratory Chemicals, Solvents & Reference Standards
M-DTDAM-2000

認証

GMP manufacture of high-purity

ISO 9001 and ISO 13485 certified Quality Management System

ICH Q7 guidelines for GMP manufacture

GMP manufacturing offered on a made-to-order basis

GMP conditions if needed for even higher quality products

DMFs for its PEG products

DMFs with the US FDA

ISO 9001 and ISO 13485 certified Quality Management Systems

DMFs for several of its PEG products

DMFs with the US FDA and China FDA at customers

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