AMERIGEN and DIPHARMA announce first regulatory submission for Miglustat 100mg Capsules

Jan

12
2016

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Lyndhurst NJ, USA, and Chiasso, Switzerland. January 12, 2016 – Amerigen Pharmaceuticals Limited and Dipharma S.A. today announced that a regulatory submission of an Abbreviated New Drug Application for Miglustat 100mg Capsules has been made with the US FDA. This filing is resulting from an exclusive collaboration between Amerigen Pharmaceuticals Limited and Dipharma S.A. to develop and commercialize Miglustat 100mg Capsules, intended to be generic equivalent of  Zavesca® 1, in markets throughout the world.  

About Dipharma

Dipharma S.A. is a Swiss pharmaceutical company specialized in developing generic high quality medicines for rare diseases. Dipharma S.A. is part of the Dipharma Group, a third generation family company founded in 1949 and  grown to a global presence. The company mission is to improve the quality of life of patients affected with rare diseases, providing them with high quality medicines at an affordable cost.


About

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in East Brunswick, NJ, USA. The group’s Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Limited, is located in Suzhou, Jiangsu Province. The group has an active portfolio of products under development, filed, or intended for filing, as ANDA’s with the US FDA and the Chinese SFDA. Amerigen’s focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen’s products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.