Bachem announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted the company a
manufacturing license in conformity with the new regulations. The license is granted for the manufacture of active pharmaceutical ingredients (APIs) for the Japanese market at Bachem’s
production facilities both in Bubendorf, Switzerland, and in Torrance, California, USA.
Meanwhile, a first Drug Master File for glucagon has already been registered, and the registration for leuprolide is expected to follow in the next few weeks.
Dr Rolf Nyfeler, CEO of Bachem, said: “We are very pleased that, with our two most important production sites in Europe and the USA, we already meet the requirements for supplying the Japanese market. We shall now successively register further product files as well,
so that we are able to offer all our important products in Japan in keeping with the new requirements.”
In April 2005, the MHLW enacted a revision of the law in the field of pharmaceuticals, according to which every company which manufactures medicines, APIs and/or excipients must be in possession of a license issued by the ministry. According to the new regulations, the registration of a product file, the so-called Drug Master File (DMF), is also required for every product marketed in Japan.
The new law provides for a transitional period until 2010. With
the license for its two production sites and the sought-after registration of the DMFs for all important products, Bachem is further reinforcing its already well-established position in the
Japanese market, and will b0e able to supply pharmaceutical and biotech companies in Japan with the necessary quantities of APIs ranging from small quantities for development projects to
bulk deliveries for successfully marketed products.