(Taiwan) API supplier ScinoPharm passes Japanese PMDA GMP inspection :: BiotechEast - Taiwan and China biotechnology, medical devices, pharmaceuticals, ^¤å½s×, ^¤å×§ï ::

(BiotechEast staff)

10 July, 2008
Tainan-based ScinoPharm Taiwan, an active pharmaceutical ingredient (API) manufacturer, announced Thursday that it had successfully passed a GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), becoming the first API company in Taiwan to do so.

"Japan is considered to have the most stringent expectations of quality and cleanliness in the world. Passing Japanese GMP and specification standards confirms, once again, ScinoPharm's consistent quality and high standard manufacturing operations," reported Dr. Jo Shen, president and CEO of ScinoPharm.

PMDA staff conducted a three-day inspection of ScinoPharm's Tainan manufacturing facilities in mid-May, evaluating areas such as quality systems, 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.

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, according to the company. 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.

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