ScinoPharm announced that its subsidiary, ScinoPharm Changshu has successfully completed a cGMP inspection by the US FDA with no resulting 483 concerns or comments. With this satisfactory inspection, ScinoPharm Changshu adds to its current record of favorable cGMP inspections by the US FDA and the Mexican regulatory authority APIF.
ScinoPharm CEO Dr. Yung Fa Chen noted that the US FDA is the most authoritative and influential drug quality inspection institution for pharmaceutical products worldwide. As the quality standards for pharmaceutics continue to increase in the U.S. and the E.U., many pharmaceutical companies in China and India have not been able to pass inspections by North American and European regulatory agencies; many were even issued warning letters and prohibited from importing their products into North America and Europe. The successful cGMP inspections of ScinoPharm’s Changshu Plant reflect ScinoPharm’s ability to comply with international quality standards.
The current FDA inspection focused primarily on in-depth examinations of the raw material management, production operations, and the quality assurance and control systems for the active pharmaceutical ingredients (APIs) and intermediates produced at the plant. After the inspection, the FDA concluded that the quality management systems at ScinoPharm’s Changshu Plant met the requirements of the U.S. cGMP standards.
Kuo-Hsi Cheng, general manager of ScinoPharm (Changshu) Pharmaceuticals, emphasized ScinoPharm’s highly competitive advantages, including cost, and its ability to provide stable and excellent quality products. 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 meet these much more stringent regulatory requirements. The Changshu Plant can also serve as a gateway for companies desiring to supply pharmaceutical products from China to the American and European markets given ScinoPharm’s high quality production capability and its extensive international experience.
To ramp up capacity utilization at the Changshu Plant, ScinoPharm is focused on multiple operational areas including self-development, licensed-in products, technology transfers, and joint development and strategic alliances. The Changshu Plant has received production permits for ten pharmaceutical products. In addition, ScinoPharm has applied to the CFDA for import drug licenses for ten of its APIs, and has also submitted, together with its strategic partners, Abbreviated New Drug Applications (ANDAs) for two oncological products. Also on going is progress on the co-development with ScinoPharm’s strategic partners of five formulations and one novel drug project, targeting the China market, with market availability scheduled from 2018 to 2020. Furthermore, ScinoPharm has over ten CRAM (Contract Research and Manufacturing Services) projects ongoing, with most at the clinical trial Phase II and III stages. These, along with the above activities will significantly increase this plant’s operational capability and utilization.
