Rotem Industries Medical Imaging is a global leader in supplying stable isotopes and radiopharmaceutical manufacturing components. We deliver exceptional quality and reliability, with a focus on innovation and customer satisfaction. We empower innovators and manufacturers to deliver cutting-edge radiopharmaceuticals.
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Current production capacity of over 450 kg/year O-18 at 98% and over 100 kg/year O-18 at 97% cGMP Q7 Guidelines production ISO 9001 & ISO 13485 U.S. FDA Drug Master File No. 19758
O-18 Enriched Water 98% in 100 gr.vial
O-18 Enriched Water 98% in 10 gr.vial
O-18 Enriched Water 98% in 30 gr.vial
The objective of Rotem’s quality system is to continuously produce and supply high quality products that comply with relevant regulatory requirements while simultaneously meeting the requirements and expectations of customers. This is implemented by every member of the Rotem team, all of whom bear responsibility for placing quality at the top of their priorities.Regulatory certifications enable users to rely on Rotem’s products when submitting their own filings (marketing authorizations, etc.) with their relevant authorities. Rotem quality systems complies with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients, ISO 9001:2015 and ISO 13485:2016 standards.
We offer a variety of manufacturing services in a clean room environment under GMP, FDA and Israeli MOH approval. OEM & CMO services include manufacturing:
Visit us at EANM 2025, Barcelona, Booth #57
21-24 JUNE 2025
