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December 02, 2021
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   GMP Carbon-14 Labeled API Manufacturing

Moravek is recognized internationally as a leading provider of GMP carbon-14 labeled APIs for use in early-phase clinical trials. Over 100 GMP APIs have been produced in compliance with FDA guidance, and all have successfully met client, CRO, and regulatory requirements.

Moravek offers outstanding CDMO capabilities and has substantial experience seamlessly coordinating concurrent progress of both CDMO and CRO activities.

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» Industry News
 
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» Featured Articles
Managing Risk in API Manufacturing is the Key to Successful Projects, Safer Drugs
Because of the nature of the business, every drug manufacturer faces the risk of unexpected events that can cause harm to consumers and cost the company money, resources and its reputation. Yet, in ... read more »
Smart IDMP: Designing a Process Fit for the Future
The EMA’s IDMP may be the first digital requirement for life sciences but it won’t be the last. Companies looking to maximize their return on investment as they switch to data-driven processes need to... read more »
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» Featured Partners
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  Formulation – a game-changer

Whether it’s an innovative new therapeutic modality or a supplier suddenly falling out of regulatory compliance, disruptions come in known challenges and unexpected obstacles. Control is what allows you to decide the shape that disruption will take. With a portfolio of over 400 excipients, formulation technologies, and global regulatory expertise, MilliporeSigma is changing the rules on ... read more »
» Featured Video
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  On-Demand Webinar: Integrated Drug Product Development – Considerations from Pre-Clinical to Commercialization
In this webinar you’ll learn about capability and planning requirements for effective integrated drug product development; phase- appropriate considerations for development programs from simple to ... read more »
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  On-Demand Webinar: Optimizing Outcomes Across the Pharma Value Chain Network
The ability of bio-pharmaceutical manufacturers to deliver quality drug products during challenging market conditions is critical for ensuring sustainability over the long run. The COVID-19 pandemic ... read more »

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» Featured Whitepaper
Whitepaper: Monitor and Control Your Mixing Process Remotely
Looking for remote monitoring and control of your mixers? It is now possible with our ready to connect control box. Read the datasheet to learn more! read more »
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