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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. 
 

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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.

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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.

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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