Eighteen years of qualification
Audited Supplier
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Xiamen Amoytop Biotech Co., Ltd., established in 1996, is a leading biopharmaceutical company in China, specializing in the research, development, manufacture and marketing of recombinant protein products. Amoytop provides not only drug product, drug substance and reagent, but also the services of contract manufacturing and contract research.
Taking quality as the most important objective, Amoytop carries out the state-of-the-art manufacturing processes under cGMP in its 36,000m2-covered plant, which is highly equipped and composed of professional staff.
As a R&D oriented company, Amoytop has already launched a series of recombinant protein products including Molgramostim, Filgrastim and Oprelvekin, and developed Interferon alfa-2a, Interferon alfa-2b, Interferon gamma, Interleukin 2 and Somatropin. Furthermore, basing on its own technical platform, Amoytop has completed the development of patented pegylated products, including Peginterferon alfa-2b (Y-shape), Pegfilgrastim (Y-shape), Peginterferon alfa-2a (Y-shape), , PEG-Somatropin (Y-shape) and PEG-EPO (Y-shape), among which Peginterferon alfa-2b (Y-shape) has been approved for marketing in China while others are in different stages of clinical trials in China now.
Aiming to improve the life quality of people, Amoytop is actively developing the international market to supply therapeutic biological products with all the endeavors.
Year of Establishment: 1996
Total Assets(USD): choose not to disclose
Total Number of Staff: 400 to 449
Main Competitive Advantages:
Other Competitive Advantages: Amoytop Biotech, as a leading enterprise on exporting recombinant protein drugs in China, has passed GMP inspections from several countries' health authorities, including Pakistan, Brazil, and Russia, etc.
Patents and Copyrights: Two patents for the structure of Pegberon® - Patent of Y-shape branched PEG structure (Y-shape): International Application No.: PCT / CN/03/ 00179, International Publication Number: WO 03/076490; - Patent of structural site and preparation process: International Application No.: PCT / CN2007 / 002644, International Publication Number: WO 2009/030066; Covers 30 regions and countries, including China, America, Europe, Japan, Korea, Canada, Australia, Russia, S . Africa, etc. Expiry date of patent: 2027
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Pharma Sources Insight JANUARY 2024
