Monrol Nükleer Ürünler A.Ş. commenced its activities in the field of nuclear medicine by importing radiopharmaceuticals.
Studies were initiated to produce the first domestic 99Mo/99mTc Generator in collaboration with TAEK-ÇNAEM (Çekmece Nuclear Research and Training Center Turkish Atomic Energy Authority).
The production of 99Mo/99mTc Generator at ÇNAEM was started and released on the Turkish nuclear medicine market.
The manufacturing of F-18 FDG (Florodeoxy-D-glucose), PET, and SPECT products were started at the facility located in TÜBİTAK Teknopark/Gebze.
Radiation Safety Certificate from TAEK and “Good Manufacturing Practices” (GMP) certificate from Republic of Turkey Ministry of Health were obtained. ISO 9001:2000 Quality Management System and ISO 14001 Environmental Management System certificates were obtained.
GMP certificate was renewed to produce radiopharmaceutical kits in order to expand the product range.
Manufacturing was started at the Ankara Facility.
Manufacturing was started at the Adana Facility.
Monrol Nükleer Ürünler Ticaret ve Sanayi A.Ş. operating in the fields of manufacturing, import, and distribution of radiopharmaceuticals used in the field of nuclear medicine has entered into a 50-50% partnership agreement with Eczacıbaşı İlaç Sanayi and became Eczacıbaşı Monrol Nükleer Ürünler Sanayi ve Ticaret A.Ş.
Licensing studies were initated for lodine-131 Oral Solution & Capsule and 99Mo99mTc Generator products in EU countries.
Manufacturing was started at the İzmir Facility.
Manufacturing was started at the İstanbul Facility. EU-GMP certificate was obtained. Mol-Image, an R&D and Advanced Technology Company involved in research, development, innovation, and manufacturing activities in the field of molecular medicine was acquired. The new PET radiopharmaceutical Na18F used in bone imaging was launched and its manufacturing was started. Manufacturing was started at the Antalya Facility.
Manufacturing was started at the Bucharest and Malatya Facilities.
Capintec, the world’s most renowned brand in radiation measurement and protection equipment used in nuclear medicine, was acquired.
Manufacturing was started at the Libya Facility.
Manufacturing was started at the Poland and Bulgaria Facilities.
Manufacturing was started at the Erbil Facility.
Manufacturing was started at the Pakistan Facility.
Lutetium Chloride manufacturing was initiated.
A distributorship agreement with Telix Pharmaceuticals was signed.
We started toexport to over 50 countries...
Studies were initiated on licensing 68Ge/68Ga Generator and MIBI & MDP kits in EU countries.
DMF approval is expected from the U.S. Food and Drug Administration (FDA) for n.c.a. Lutetium (177Lu) Chloride
DMF approval was obtained for n.c.a. Lutetium (177Lu) Chloride from the U.S. Food and Drug Administration (FDA).