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EMPROVE® exp for use as excipient

As drug approval procedures grow stricter, regulatory requirements are becoming more demanding for excipients. Our high-quality EMPROVE® exp raw materials for use as excipients not only comply with relevant regulations, but also come with detailed documentation, facilitating lower costs of qualification, so you can get to market faster.

Choose your EMPROVE® exp dossier

EMPROVE® exp dossiers comprise information on the manufacturer and manufacturing process. They provide specifications in accordance with the requirements of a variety of pharmacopoeias, as well as details on impurities, stability data and a certificate of analysis (CoA). This way, we help reduce your workload and accelerate your qualification processes.

Features of the EMPROVE® exp portfolio:

Complete Dossier
(Basic, Analytical, Stability-Dossier)

  • Update every 12 month
  • CDA necessary
  • Charged

Basic Dossier

  • Available online
  • Free of charge

Analytical Dossier
(Basic Dossier+Analytical Method)

  • CDA necessary
  • Charged

Stability Dossier
(Basic Dossier+Stability Method)

  • CDA necessary
  • Charged
All in line with CTD format

Click here for a comprehensive list of EMPROVE® exp products.

For more information on all EMPROVE® dossiers, please click here.

© Merck KGaA, Darmstadt, Alemania, 2014


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