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Zhejiang Hisun Pharmaceutical Co., Ltd was established in 1956 and has evolved into one of the largest bulk Active Pharmaceutical Ingredient (API) manufacturers in China. Hisun ranks among the top 20 Pharmaceutical companies in China as well as in the top 500 Chinese companies overall.
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Hisun exports 80% of API production to North America, Europe, South America, and Asia. Hisun has had 7 successful FDA inspections since 1992. Currently, Hisun has 8 FDA product approvals, 5 EDQM (CoS) approvals, and 73 products registered throughout the major pharmaceutical markets worldwide.
Hisun Pharmaceutical is a member of the Hisun Group, which also includes Hisun Chemical, a producer of pharmaceutical intermediates and agrochemicals, Hisun Pharmaceutical Research Institute, and Hisun Botanical, a manufacturer of Traditional Chinese Medicines (TCM).
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Research and Development
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Hisun’s new state-of-the-art Pharmaceutical Research Institute was established in 2001. The focus of this new facility is to improve the core competency of producing cGMP quality active pharmaceutical ingredients through organic synthesis and fermentation. |
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In this facility, Hisun will develop new R & D projects, including biologicals, and joint R&D projects and contract research with multinational pharmaceutical companies.
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Technical Strength
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Hisun’s technical strength includes Fermentation and Organic Synthesis. Hisun is one the largest Chinese producers of Anti-Infectives, Oncologicals, Cardiovascular, and Animal Health Drugs. In addition, Hisun is producing finished dosage products, including tablets, capsules, and injectables.
Hisun has invested over 10 million USD over the past five years in plant renovation and new construction. Key process parameters are computer controlled. Hisun utilizes various drying technologies in its production including lyophilization, rotary drying, spray drying, filter drying, and conical mixing drying. In addition, Hisun filtration technologies include press filtration, cermanic membrane filtration, reverse osmosis, nanofiltration, and ultra filtration.
Hisun has established long-term relationships with more than 20 world class Chinese research institutes. These relationships provide Hisun with an additional source of R & D projects for new and existing molecules as well as Traditional Chinese Medicine (TCM).
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Regulatory Affairs
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The regulatory affairs department at Zhejiang Hisun Pharmaceutical Co., Ltd. provides a complete range of regulatory and technical services in support of development, registration and product approval throughout the world.
The key to regulatory success is a full and complete range of efficient regulatory services and documentation in combination with experience in dealing with the changing regulatory environment. Our experienced team enables us to respond quickly and reliably to quality assurance issues, technical service requests, and assist in all aspects concerning regulatory submissions. Our experience, knowledge, and excellent working relationship with various governmental agencies help us to expedite regulatory product approvals.
As a GMP facility, Zhejiang Hisun Pharmaceutical Co., Ltd. has been inspected by the United States Food and Drug Administration (FDA) 7 times within the past 10 years and has maintained its approval status during this period. Over 25 Drug Master Files (DMFs) are currently filed in the United States and with various regulatory authorities throughout the world. This in combination with over 10 Certificate of Suitability applications filed with the EDQM rank Hisun as one of the world leaders in regulatory submissions, product approvals and compliance. |
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