Monrol Announces Investment to Expand its n.c.a. Lu-177 Production Capacity
11.9.2023 19:15:00 EEST | Business Wire | Press release
Eczacıbaşı Monrol Nuclear Products Co. (Monrol), one of the world's leading radiopharmaceutical producers, has decided to invest 35 million Euros to increase its production capacity for non-carrier-added Lutetium-177 (n.c.a. Lu-177) in response to growing global demand for this product.
Monrol, which manufactures radiopharmaceuticals meeting high quality standards at its production facilities, plans to increase its current n.c.a. Lu-177 production capacity through the expansion of existing production lines at the Monrol Gebze facility in Turkey as well as the establishment of a new production facility at the Gebze campus. The expansion project will come into operation gradually and reach full capacity by 2026.
N.c.a. Lu-177 is the radionuclide that forms the basis of targeted radioligand therapy(*), widely used today in the treatment of prostate cancer and neuroendocrine tumors and expected to be used soon to treat other cancers as well.
“Prostate cancer is the most common type of cancer in men after lung cancer, with its incidence increasing rapidly around the world. By 2040, 2.3 million new cases of prostate cancer are predicted annually worldwide. The production capacity increase at our Gebze facility in Turkey, which will comply fully with EU and US quality standards, will meet the increasing global demand for n.c.a. Lu-177. In fact, we aim to make the Gebze production facility a “center of excellence” for the production of theranostic products,” commented Aydin Kucuk, General Manager of Monrol.
(*) Targeted radioligand therapy, is an innovative approach to cancer treatment. Multiple clinical trials are investigating the effects of this treatment approach on various types of cancers across the world.
ENDS
About Monrol
Headquartered in Istanbul, Monrol is a nuclear medicine company leading innovation for the development and manufacturing of GMP grade radioisotopes and radiopharmaceuticals, Monrol distributes its world-class radiopharmaceutical products portfolio in global markets. As both a CMO and CDMO, Monrol provides early development support to customers and offers fully integrated services for nimble, lean, virtual companies taking new product concepts into clinical trials, demonstrating proof of concept, and going into first-in-human studies. Monrol is committed to transform and improve patient journey in cancer treatment through a portfolio of radiopharmaceutical products that it distributes to more than 60 countries around the globe. To learn more, visit www.monrol.com and LinkedIn.
About n.c.a. Lutetium-177
Lutetium-177 n.c.a. is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a. enables treatment options that have the potential today to improve treatment outcomes for certain cancer patients and may soon offer improved treatment options for others, thanks to ongoing clinical development. The unique properties of Lu-177 n.c.a. make it a desirable radioisotope for peptide receptor radionuclide therapy (PRRT) used to treat certain cancers like Neuro Endocrine Tumors (NET) and Prostate cancer. Monrol n.c.a. Lutetium-177 DMF has been listed by the FDA.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230911648623/en/
Contact information
For further information please contact:
Monrol
Aydın Küçük
General Manager
monrol@monrol.com
Media Enquiries
Alkim Aydın
Marketing Manager
alkim.aydin@monrol.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli ® (Relacorilant)18.9.2026 15:00:00 EEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu ® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 15:00:00 EEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In DES
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca ® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 13:58:00 EEST | Press release
Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare disease and specialty care in areas where there is significant unmet patient need, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), an oral, once-daily JAK1 preferential inhibitor, for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy. Following this positive opinion, the application is now referred to the European Commission (EC) for final action. The EC’s decision is expected in the next weeks. “At present, half of people living with axSpA fail to adequately respond to treatment, leaving them with years of preventable struggle with persistent pain and other impactful symptoms,” said Daniele D'Ambrosio, Chief Development Officer, Alfasigma. “This
IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer18.9.2026 13:38:00 EEST | Press release
For business and medical media only This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918325771/en/ Stephan Eder, CEO, Pharmanovia IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer. Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will
Estithmar Holding Announces Completion of 48.68% Stake Transfer in Shahba Bank to Masaref Holding, a Subsidiary of Estithmar Capital18.9.2026 12:48:00 EEST | Press release
Estithmar Holding Q.P.S.C. announced the completion of the transfer of a 48.68% stake in Shahba Bank to Masaref Holding LLC, subsidiary of Estithmar Capital, Estithmar Holding’s financial services and investments arm. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918807909/en/ Estithmar Holding Announces Completion of 48.68% Stake Transfer in Shahba Bank to Masaref Holding, a Subsidiary of Estithmar Capital (Photo: AETOSWire) As a shareholder, Masaref Holding intends to support the assessment of proposals aimed at strengthening Shahba Bank’s financial, operational and technological capabilities, including potential capital enhancement, branch network expansion, and the development of products and services for individuals, businesses and SMEs. The proposals may include modernizing banking and operational systems, develop digital services, and strengthen governance, compliance, risk management and cybersecurity to enhance
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom