Moravek Inc. Brea, California , USA

About Moravek Inc. :

With over 45 years of experience, Moravek is a leading provider of high-quality carbon-14 and tritium labeled compounds to researchers worldwide and is one of the most trusted contract development and manufacturing organizations (CDMOs) offering radiosynthesis services. Moravek specializes in the custom production of GMP carbon-14 labeled active pharmaceutical ingredients (APIs) that are manufactured compliant with U.S. Food and Drug Administration (FDA) guidance ICH Q7 Section 19 and are suitab...le for use in early phase clinical trials. Moravek also offers non-GMP custom synthesis services and an extensive catalog of non-GLP radiolabeled, stable-labeled, and non-labeled compounds.

GMP Carbon-14 Labeled APIs
Moravek’s team is highly experienced in the custom synthesis, purification, analysis, and release of GMP carbon-14 labeled APIs for use in early phase clinical trials. We have successfully prepared over one hundred GMP carbon-14 labeled APIs for many leading pharmaceutical companies and research institutions. With our knowledgeable radiochemists, proactive project managers, and experienced Quality Assurance and Quality Control teams, Moravek has the expertise and capacity to supply custom carbon-14 labeled APIs that consistently meet regulatory requirements and are on time for your clinical trial. read more

Service Offerings:

• GMP 14C-Labeled APIs
• Quality Control
• Quality Assurance
• Long-Term Storage
• 3H-Labeled Compounds
• Stable-Labeled Compound
• Non-Labeled Compounds
• Analytical Development
• Analytical Services
• Stability Studies

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