Our quality promise is EXCiPACT® certified.
What are excipients?
Excipients play a decisive role in the formulation of pharmaceutical products. They serve to ensure the stability, shelf life and efficacy of medicinal products. Find out more about the different types of excipients and their importance in pharmaceutical production here.
Our quality promise through EXCiPACT® certification
EXCiPACT® is an international non-profit organization that offers a certification process for manufacturers and distributors of excipients. Completing the program ensures that manufacturers and distributors work in accordance with the regulatory quality standards of GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice).
We are proud that our company has been awarded EXCiPACT® certification. This certification demonstrates our commitment to the highest quality standards and safety in the production of excipients for the pharmaceutical industry.
Download EXCiPACT® certification
Download EXCiPACT® Flyer
Put your trust in our experience
With many years of experience in the pharmaceutical industry, we are pleased to be able to offer you excipients directly for this application and to be able to officially present the high standard we have built up over many years to the outside world.
To ensure the quality and safety of our products, we take the time to gradually expand our range of high-quality additives with great care. If an excipient you require is not yet in our range, please do not hesitate to contact us. Our product management team will be happy to help you directly.
This is what you can expect from our brands:
Overview documentation of the various ROTH qualities
Properties |
Pharmaceutical Qualities |
Pharmaceutical Qualities |
Purities | Ph. Eur. USP BP |
ROTI®Pharm Excipient Products listed in Pharmacopoeias (Ph. Eur., USP, BP), Extensive Documentation and Supplier Management |
QMS Minimum | 9001 | 9001, GMP or EXCiPACT® |
Product Specification | ||
Certificate of Analysis | ||
Recommended Retest Date (ERD) | ||
Supplier Management Evaluation/Development | ||
Two-stage Product Release | ||
Identity Verification | ||
Product Origin Statement Origin/BSE/TSE/GMO/Allergens |
||
Hygiene Monitoring | ||
CleanRoom Production | ||
Extended Supplier Managment Qualification/Auditing |
– | |
Test Methods | – | |
Change Control Agreement | – | |
Change Management | – | |
Retention Sample | – | |
Batch Rekord Review | – | |
Solvent Residues | – | |
Metallic Impurities | – | |
Nanoparticles | – |