ZHEJIANG HISYN PHARMACEUTICAL CO., LTD. DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

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ACTIVE PHARMA INGREDIENTS

8 All APIs, 2 CEP/COS, 7 KDMF

8 All APIs
2 CEP/COS
7 KDMF

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About

HISYN is the former Xinhua Pharmaceutical founded in 1998. Since the beginning of its history that Contrast Media APIs are the core business for HISYN. Process development for Iohexol and Iopamidol has been performed in house and are nowadays the best selling products at HISYN. HISYN has established a new manufacturing site in 2005 and in the same year received the GMP certificate from the Chinese Health Authorities. After some years of close relationship with Hovione as a supplier of Contrast Media intermediates, HISYN and Hovione have established a Joint Venture in February 2008, whereby Hovione has become the majority shareholder of the Company. Currently HISYN is fully dedicated to the development and production of high quality Contrast Media APIs. HISYN is committed to developing and manufacturing a full range of generic Contrast Media APIs. Through sound science and faultless execution HISYN offers product that meets world standards of Quality and GMP at large scale. HISYN provides technical and regulatory support to its customers. HISYN establishes long term relationship with its customers based on reliable delivery and manufacturing carried out in full compliance with cGMP standards. The company has established an R&D Centre in Shanghai where all the development is performed. On R&D, the chemists focus on efficient synthetic routes which allow HISYN to have a competitive advantage on the market. HISYN’s manufacturing site has a total area of 100,000 m2 where 25,000 m2 is dedicated to workshops with a total investment of approximately RMB 110 million. Hisyn was inspected and approved by the Japanese Health Authorities (PMDA), in November 2008 and September 2010.

DDL ConferenceDDL Conference

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10-12 December, 2025

Edinburgh
AESAES

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05-09 December, 2025

Atlanta, GA
Cell BioCell Bio

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06-10 December, 2025

Philadelphia, U.S.A