Bachem production facilities licensed for the manufacture of APIs for the Japanese market
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 be 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.
Bachem Holding AG
Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides.
Press releases you might also be interested in
Weitere Informationen zum Thema "Biotechnik":
Splunk unterstützt Amazon Kinesis Firehose und GuardDuty
Der Machine-Learning-Spezialist Splunk ist eine strategische Zusammenarbeit mit Amazon Web Services (AWS) eingegangen. Ab sofort sind Integrationen in Amazon Kinesis Firehose und GuardDuty verfügbar.Weiterlesen