Registering an API is complex and thus very time-consuming. That’s why we’ve offer EMPROVE® api: high-quality raw materials for use as active pharmaceutical ingredients.
EMPROVE® api raw materials are produced according to cGMP guideline ICH Q7. What’s more, all of our EMPROVE® API production plants are located in Western Europe and follow current environmental standards. And in order to support your products’ compliance with international standards, our Regulatory Affairs team offers dedicated regulatory support with access to DMFs, CEP and ASMF.EMPROVE® api Portfolio Features:
- Manufactured according to ICH Q7
- Access provided to DMFs, CEP and ASMF
- CDA necessary for ASMF/DMF
- Regulatory documentation is charged