ScinoPharm Passes Japanese PMDA GMP Inspection
ScinoPharm Taiwan, a leading active pharmaceutical ingredient (API) supplier to the global pharmaceutical and biotechnology industry, announced it has successfully passed a GMP inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). ScinoPharm will become the first pharmaceutical active ingredient manufacturer in Taiwan to be qualified by the recently established PMDA.
With its satisfactory inspection, ScinoPharm adds to its current record of GMP approvals by various international regulatory agencies which include the United States FDA, Australian TGA, and one of the EU countries (Hungarian NIP).
ScinoPharm, specializing in cytotoxic and high potent APIs, has grown from a regional to a global API manufacturer with significant market presence in the supply of oncology APIs worldwide.
To acquire new orders, the company has acted swiftly in worldwide regulatory registrations of the drug master file (DMF) for its APIs. ScinoPharm recently completed one additional US DMF registration for its oncology API Topotecan HCl, bringing its total US regulatory registrations to 23 and worldwide registrations to over 240.
The Pharmaceuticals and Medical Devices Agency (PMDA), which operates under the Japanese Ministry Of Health, Labor and Welfare (MHLW), conducted a 3-day on-site inspection of ScinoPharm’s Tainan manufacturing facilities in mid-May 2008. The inspection evaluated items including the quality system, facilities, storage, manufacturing, packaging and labeling, and laboratories.
Japanese regulatory notification of GMP compliance gives ScinoPharm a green light to supply its quality APIs to Japan’s expanding generic market. Japan’s pharmaceutical market is the world’s second largest individual market after the United States. “We will continue to expand our international presence by establishing strategic partnerships with drug makers in Japan,” Dr. Shen added.
In 2007, generic medicine was estimated to account for 17 percent of the total medicine market in Japan in 2007, compared to 65 percent in the United States. Recently, Japan’s generic industry has been spurred by government policy to encourage the use of less expensive off-patent drugs. This signals a significant growth potential for the Japanese generic industry which ScinoPharm aims to capitalize on with its now-qualified APIs. In addition, recently revised laws allow Japanese pharmaceutical companies to outsource 100 percent of their drug manufacturing to outside contractors, creating new opportunities for PMDA qualified contract research and manufacturing (CRAM) organizations such as ScinoPharm Taiwan.
About ScinoPharm Taiwan
ScinoPharm Taiwan, Ltd. is a leading high quality API supplier to the global pharmaceutical and biotechnology industry. We provide a full range of API services from process development, production of early phase clinical trial material to large-scale manufacturing for commercial launches. The company currently serves more than 190 customers worldwide. For more information, please visit the company’s web site at http://www.scinopharm.com.
Contact:
Jessie Wang
Tel: +886-6505-2888
Email: Jessie.Wang@scinopharm.com.tw