With over 45 years of experience, Moravek is a leading provider of high-quality carbon-14 and tritium labeled compounds to researchers worldwide and is one of the most trusted contract development and manufacturing organizations (CDMOs) offering radiosynthesis services. Moravek specializes in the custom production of GMP carbon-14 labeled active pharmaceutical ingredients (APIs) that are manufactured compliant with U.S. Food and Drug Administration (FDA) guidance ICH Q7 Section 19 and are suitable for use in early phase clinical trials. Moravek also offers non-GMP custom synthesis services and an extensive catalog of non-GLP radiolabeled, stable-labeled, and non-labeled compounds.
GMP Carbon-14 Labeled APIs
Moravek’s team is highly experienced in the custom synthesis, purification, analysis, and release of GMP carbon-14 labeled APIs for use in early phase clinical trials. We have successfully prepared over one hundred GMP carbon-14 labeled APIs for many leading pharmaceutical companies and research institutions. With our knowledgeable radiochemists, proactive project managers, and experienced Quality Assurance and Quality Control teams, Moravek has the expertise and capacity to supply custom carbon-14 labeled APIs that consistently meet regulatory requirements and are on time for your clinical trial.
Custom Non-GMP Isotopically Labeled Compounds
Moravek routinely carries out custom manufacturing of non-GMP compounds labeled with radioisotopes (carbon-14 and tritium) as well as compounds labeled with stable isotopes (primarily carbon-13, deuterium, and nitrogen-15). Our chemists are proficient in a wide variety of synthetic techniques and are able to prepare nearly any compound, including all U.S. Drug Enforcement Administration (DEA) Schedule I – V controlled substances. Once the synthesis is complete, our talented purification and analytical chemists will ensure that your compound meets agreed-upon specifications.
Non-GLP Catalog Items
Moravek offers an extensive selection of radiolabeled, stable-labeled, and non-labeled compounds, such as nucleosides, nucleotides, amino acids, antivirals, and anticancer compounds. A variety of isotopes and label positions are available to suit many of your research needs.
Moravek’s rigorous Quality System is compliant with ICH Q7 Section 19, which has been adopted by regulatory agencies including the FDA and provides guidance regarding good manufacturing practices for the production of APIs for use in early phase clinical trials.
We welcome Quality Assurance audits of our facilities.
Certifications and Licenses
Moravek manufactures GMP carbon-14 labeled APIs under a Drug Manufacturing License issued by the California Department of Public Health – Food and Drug Branch following an audit of our Quality System. GMP production is carried out in one of four cleanrooms which are annually certified to be ISO Class 7 compliant. Moravek also has a license from the DEA to handle the full range of Schedule I – V controlled substances.