Medi-Radiopharma Co., Ltd is a Hungarian privately held company founded in 1997. The scope of the company is research, development, manufacture and trade of active radiopharmaceutical ingredients and radiopharmaceuticals. Medi-Radiopharma Co., Ltd. is active in the fields of Nuclear Oncology developing various diagnostic and therapeutic radiopharmaceuticals.
The main goal of the company is to supply a wide range of generic diagnostic in vivo kits for diagnostic purposes and its mission is to develop and manufacture high quality products to support the everyday work of the nuclear medicine departments all over the world. The company retains in close links with the authorities and with help of the distributors and other scientific expert partners and end-users abides by all the regulatory restrictions and the latest guidelines (e.g. pharmacovigilance).
In 2002 the company moved into a compfortable completely refurbished two-storey site, with a floor place of 800 m2, where the kits are produced and evaluated under continuously and automatically controlled aseptic conditions. The company was awarded a regularly renewed full GMP status in 2002. The last renewal was in 2012. In 2004. the company was also awarded the ISO 9001:2000 awarded in 2004 accreditation and in 2006. its scope was extended with the manufacture of active pharmaceutical ingredients. The last certification was performed in 2013 according to ISO 9001:2008.
The pharmaceutical production performed in the facility includes aseptic processing, filling, autoclaving, freeze-drying, labelling and packaging supported by in-process and quality control release, stability storage and testing.
Nowadays, the company operates in close cooperation with its partner company Radiopharmacy Laboratory Co., Ltd. in its headquarter and two sites (Buda√∂rs and B√°tonyterenye). The sites have well equipped modern laboratories necessary for the manufacture and quality control of the in vivo kits.
The territory of the central manufacturing site is located on a 2000 m2 land. The total area of the buildings amounts 1000 m2, and the size of the aseptic manufacturing area is 250 m2.
To learn more about our site and laboratories, take a look at our introduction video.