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   Clinical Supplies Manufacturing
   
 

Using good scientific practices, our goal is to move the compound from the preclinical into the clinical development stage as quickly as possible.

During the development process, EmcureUSA and the customer review the formulation data and agree upon the manufacturing schedule for clinical trial supplies based on the customer’s needs and API (Active Pharmaceutical Ingredient) availability. This enables our customers to make timely decisions from proof of principal studies regarding future clinical development plans.  

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Clinical Trial Material (CTM) Manufacturing and Packaging Services  

This facility can manufacture supplies to support:

- Phase I studies 
- Phase II studies 
- Phase III studies 
- Phase IV studies  

Production scalability allows for the manufacture of Clinical Trial Material (CTM) from less than 1 kilogram to 250 kilogram batch sizes.  

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U.S. Drug Enforcement Administration (DEA) Scheduled Compounds  

The facility can develop and manufacture CTM supplies for Schedule III, IV and V DEA scheduled compounds.

   
   
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