Holbaek, Denmark: Pharmacosmos is pleased to announce that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has GMP approved Pharmacosmos for the manufacturing of its main IV iron.
“The GMP application process and following drug registration has run with clockwork precision, and it is a great pleasure that we have received GMP approval on the day predicted at the initiation of the project,” said Lars Christensen, MD, President and CEO of Pharmacosmos A/S.
The registration approval has been completed in collaboration with Pharmacosmos’ strategic partner Nippon Shinyaku Co., Ltd (Headquarters, Kyoto, Japan; President, Toru Nakai) – a leading pharmaceutical company with more than 2000 employees and with a track record of bringing new innovative products to the Japanese market since its establishment more than a century ago.
With the Japanese approval in the world’s 3rd largest pharma, Pharmacosmos products have now obtained drug registration approval in all of the major pharmaceutical markets such as US (FDA), China (NMPA), Europe (EMA), Canada (FDA), Australia (TGA), Brazil (ANVISA), etc.
Tobias S. Christensen, COO
+45 5948 5959, firstname.lastname@example.org
NIPPON SHINYAKU CO., LTD.
Corporate Communications Dept., Nippon Shinyaku
TEL: +81-75-321-9103 FAX: +81-75-321-9128
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