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.

 

Moravek’s State of California D.H.S. License Inspection Report follows. The report includes the remark “no unsafe condition or item of noncompliance was identified.” This assessment is noteworthy and reflects the safety expertise and decades long history of safe operation of Moravek.