APIs Tailored to Your Needs

The Highlights of our API Pharmaceuticals at a Glance

• All APIs are manufactured under the ICH Q7 GMP guideline
• Regulatory e-submissions (e.g., US-DMF, CEP, ASMF) to support your drug product marketing authorization
• Compliant with key pharmacopoeias worldwide to meet international quality standards
• Life-impacting APIs, covering a wide range of applications from enteral and parenteral nutrition to oncology, from ophthalmic to plasmapheresis and dialysis, etc.
• Suitable for liquid, solid and semisolid formulations

Emprove^® API Evaluation and Risk Management

With our active pharmaceutical ingredients under the Emprove^® Program we provide dedicated regulatory support worldwide throughout the entire registration process and an excellent compliance track record.

• Manufactured under ICH Q7 GMP guideline
• Regulatory e-submissions (e.g., US-DMF, CEP, ASMF)
• Emprove^® API Information Package* included to speed up your qualification and risk assessment

Emprove^® API products come with the Emprove^® API Information Package* which supports API qualification and risk assessment. It includes:

• General Information
• Manufacture
• Specification
• Regulatory Certificates
• Product Quality Self Assessment
• Packaging Information
• Stability Summary and Conclusion

*Disclaimer: The API Information Package is not intended to be used as an official document for registration by the authorities. The registration procedure for active pharmaceutical ingredients in final drugs is strictly regulated. The CEP and DMF/ASMF procedures enable API manufacturers to protect their intellectual property. Access to CEPs and LoAs for US DMFs (and other DMFs) and ASMF applications can be provided on request to support drug applications using our Emprove^® API.