Under the brand name of LuMark®, Lutetium 177 is being produced on a weekly basis. With daily shipments to destinations all over the world LuMark Lu-177 has already established itself as the leading brand of Lutetium 177.
About GMP produced Lutetium 177
IDB Holland is the proud owner of the only fully GMP Lu-177 production facility in the world. Based in Baarle-Nassau in the Netherlands, IDB Holland offers their brand LuMark® Lu-177 to countries all over the world.
GMP production facilities of Lutetium 177
The total production facilities of Lutetium 177 at IDB Holland consists of:
– 2 Class B GMP production laboratories
– 1 fully automated Class A production line
– 1 Class C quality control laboratory
– 1 Class B microbiology laboratory
The whole production and laboratory facilities are devised for the GMP production of Lutetium 177. In 2011 it was officially opened. Today IDB Holland complies with GMP, EMEA and FDA regulations, being the only Lutetium 177 production facility that complies at the fullest levels to all these conditions.
Lu-177 specification sheet and GMP release certificate
With every delivery of Lu-177 customers will find a production sheet, a certificate of analysis and a GMP release certificate. These are official documents signed by designated officers that supply all important information in full compliance with regulations.
Packed according to IATA regulations for worldwide shipping
LuMark® Lu-177 is filled in specially designated vials with a rubber stopper and aluminum capping. These vials are then put in lead boxes. For transportation these lead boxes are again packed in carbon boxes meeting all regulations of IATA for worldwide shipping.