18 Dec 2013, BioSpectrum Bureau , BioSpectrum
Singapore: ScinoPharm has completed construction of its Changshu plant on a 16-acre (6.5-hectare) site in China, which includes an R&D process development center and a multipurpose API (active pharmaceutical ingredients) manufacturing plant fully compliant with US, EU and Chinese cGMP standards.
A total of $113 million was invested in this facility. The new plant will work together with ScinoPharm Taiwan in the production of new international and generic drugs and to respond to the domestic demands of the Chinese market. The plant has already received drug production licenses from the Chinese FDA for four API products.
Dr Jo Shen, president and CEO, ScinoPharm, stated that China would 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 niine of the top 20 oncological products used in China.
The Changshu plant is the first API production plant to be built in accordance with the latest GMP requirements announced by the China Food and Drug Administration (CFDA) and is expected to benefit from reduced competition resulting from many existing companies' inability to comply with these much more stringent compliance requirements.
The Changshu plant is equipped to manufacture high-potency, anti-tumor, hormonal-active pharmaceutical ingredients and intermediates in highly contained facilities. In addition, the plant is also able to 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 to meet increasing market demands as its customer's business expands and product quantities grow.
During the inauguration ceremony, Dr. Jo Shen also signed an agreement with the Economical Development Zone to purchase an additional 108 acres (43.2 hectares) of adjoining property to be used for the development of future API production lines and for the construction of future formulation production plants. ScinoPharm is clearly committed to being a significant participant in the rapidly growing Chinese pharmaceutical market and has established distinctive long-term strategies to achieve these goals.
The Changshu plant can also serve as a primary link for companies desiring to supply pharmaceutical products from China to the American and European markets given ScinoPharm's high quality production capability and its vast international experience. This large facility will also allow ScinoPharm to quickly respond to the demands of the market place while providing a single-source service with the capability of adding additional down-stream value as well as long-term partnerships with its customers.