Certifications & Licenses

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

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Moravek can prepare nearly unlimited variety of GMP [14C] API’s and Drug Product including all scheduled substances 1, 2, 3, 4 and 5 without restriction under Manufacturing 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 GMP. 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.