EMPROVE® api for use as active pharmaceutical ingredient
Ensuring highest quality and safety
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- EMPROVE® api – Your tool for active pharmaceutical ingredients
EMPROVE® api – our expertise for your success
As a matter of course, Merck’s EMPROVE® api raw materials for use as active pharmaceutical ingredient offer the excellent quality you have come to expect from a global pharmaceutical company with vast experience in drug research and production. EMPROVE® api meets customer needs and for effective regulatory support through comprehensive, ready-to-use documentation. In short: EMPROVE® api helps you to achieve maximum product safety, lower costs of drug registration processes, and faster time to market.
Emprove api for highest standards
EMPROVE® api products fulfil the highest quality and safety standards with regard to current and future regulatory requirements in the pharmaceutical industry. Production occurs under cGMP requirements as defined in the ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, being implemented as EU GMP Guide Part II.
Your EMPROVE® api documentation
The supplied documentation comprises Certificates of Suitability of the European Pharmacopoeia (CEP), Active Substance Master Files (ASMF), and/or Drug Master Files (DMF). ASMF and DMF as well as CEP documentation meet the CTD format requirements. (Note: There are no EMPROVE® dossiers available for EMPROVE® api products.)
For more information, please contact us.
