April 19, 2022 Pharmacosmos receives Japanese GMP approval

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.

Contact information


Pharmacosmos
Tobias S. Christensen, COO
+45 5948 5959, info@pharmacosmos.com

NIPPON SHINYAKU CO., LTD.
Corporate Communications Dept., Nippon Shinyaku
TEL: +81-75-321-9103   FAX: +81-75-321-9128

 

About Pharmacosmos Group


Pharmacosmos Group, headquartered in Holbaek, Denmark, and founded in 1965, is a highly specialised company focused on carbohydrate chemistry and a global leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anaemia. With companies in the UK, Nordics, Germany, the USA, and China, as well as through partners, Pharmacosmos markets its products across the world. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with deep expertise in the synthesis of iron-carbohydrate complexes.

About NIPPON SHINYAKU CO., LTD.


Our mission is to help people lead healthier and happier lives. Through creating unique medicines that will bring hope to patients and families struggling with illness, we aim to be an organisation trusted by the community. Please visit our website for products or detailed information.

Pharmacosmos

Please identify if you are a:

;