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577 Mercury Lane, Brea, CA, 92821, US
Moravek is a leader in API GMP solutions, with the ability to prepare 14C and 3H radiolabeled APIs for Phases 0, I, and II mass balance and microdosing (Phase 0 and Phase I) studies. We perform GMP synthesis, purification, testing, and QA release in compliance with FDA Phase 0, I, and II GMP guidance (ICH Q7 Section 19). In our GMP synthesis, purification, testing, and QA release processes, we analyze radiolabeled APIs that have been produced and purified under GMP conditions. These compounds are analyzed on qualified analytical instrumentation and are supplied with a complete batch record, which includes documentation of the synthetic, purification, and analytical processes from start to finish.
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