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To provide R&D process development and API manufacturing
December 12, 2013
By: Kristin Brooks
ScinoPharm has completed construction of its $113 million plant in Changshu, China. The facilities include an R&D process development center and a multipurpose API manufacturing plant that is compliant with U.S., EU, and Chinese CGMP standards. The new plant will work together with ScinoPharm Taiwan for the production of new international and generic drugs, as well as the domestic demands of the Chinese market. The plant has already received drug production licenses from the Chinese FDA for four API products. The Changshu plant is equipped to manufacture high-potency, anti-tumor, hormonal APIs and intermediates in highly contained facilities, as well as manufacture new products in smaller quantities for sales evaluations and for GMP samples. Its large-scale production lines are capable of manufacturing various types of APIs in larger quantities. The Changshu plant can also serve companies looking to supply pharmaceutical products from mainland China to the American and European markets, according to a ScinoPharm statement. Additionally, ScinoPharm has signed an agreement with the Economical Development Zone to purchase an additional 108 acres of adjoining property for the development of future API production lines and for the construction of future formulation production plants. Dr. Jo Shen, president and chief executive officer of ScinoPharm, said, “Mainland China will become the second largest pharmaceutical market in 2015. The completion of ScinoPharm’s Changshu plant significantly expands the company’s capacity to respond to increasing global market demands for generic and other cost effective products. This plant will also serve as the base for the company to develop its API business in China. ScinoPharm has already developed nine of the top 20 oncological products used in China.”
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