Certifications & Licenses

cGMP Active Pharmaceutical Ingredients (APIs) and Drug Products are manufactured under license from the California Department of Health while adhering to FDA cGMP guidance ICH Q7 Section XIX.

Moravek can prepare nearly unlimited variety of cGMP [14C] API’s and Drug Product including all scheduled substances 1, 2, 3, 4 and 5 under Analytical License from the Federal Drug Enforcement Administration.

All three of Moravek’s highly engineered ISO Class 7 clean rooms are purpose built and dedicated exclusively to carbon-14 radiolabeling of API manufacture under cGMP. All three clean rooms are operated under current ISO Class 7 qualification, have HEPA filter integrity tests and are recertified to meet Class 7 performance levels semi-annually.