cGMP [14C] API Radiolabeling
Radiolabeling
Organic Synthesis Chemistry Services
QC & Analytical Support
Moravek has been committed to the advancement of human health through provision of quality products for research since 1975 and is licensed by the California Department of Health Services (DHS) Food and Drug Branch for the preparation and C-14 labeling of active pharmaceutical ingredients (API) for clinical trials.
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Our custom radiosynthesis, purification, dilution, release, radiochemical stability testing, and QA reviewed documentation process consistently achieves cGMP compliance and assurance of quality.
All of the over 250 cGMP 14C labeled APIs provided by Moravek were suitable for use in early phase clinical trials in the US and around the world.
With one of the largest radiochemistry groups and state-of-the-art facilities and equipment, Moravek has the expertise and capacity to supply custom radiolabeled APIs that meet release specifications and are on time for your clinical trial.
In addition to cGMP radiosynthesis, solutions offered by Moravek include non-GMP radiosynthesis of carbon-14 and tritium labeled compounds, extensive GLP analytical services and a catalog of over 2,500 highly pure non-GMP radiolabeled compounds for research.