GMP active pharmaceutical ingredients (APIs) are manufactured under license from the California Department of Public Health – Food and Drug Branch while adhering to FDA GMP guidance ICH Q7 Section 19.
Moravek can prepare a nearly unlimited variety of GMP carbon-14 labeled APIs including the full range of schedule 1 – 5 substances under a license from the Federal Drug Enforcement Administration.
All four of Moravek’s highly engineered ISO Class 7 clean rooms are purpose built and dedicated exclusively to GMP labeled API manufacturing. All four clean rooms are operated under current ISO Class 7 qualification, have HEPA filter integrity tests, and are periodically recertified to meet Class 7 performance levels.
