Certifications, Regulatory Compliance, Quality & Safety
We produce our excipients for pharmaceutical industries in three different facilities in Germany and France. If you require any of the pharma certifications of our sugars for your formulations, please ask – we are happy to provide them.
With our global commercial presence and reliable cross-border supply, we offer you perfect traceability from production until delivery.
Since we perform regular analyses during production according to the methods of the sucrose monograph in force, all our sucrose-based excipients comply with the requirements of the sucrose monograph of PhEur (excluding dextrins and endotoxins).
If you request it, we also furnish PhEur certificates of analysis per production batch of our products, according to the European Pharmacopoeia. On top of that, we’ll also supply USP-NF certificates of analysis (United States Pharmacopeia National Formula) for some of the products and raw materials we use if needed. We can also provide customer-specific certificates upon request.
Apart from that, we enclose a certificate of conformity to the sucrose monograph of the European Pharmacopoeia in each delivery.
If you need more information or have questions regarding our certifications, please contact us.
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Are you interested in our sucrose based excipient products? Do you want to know more about further customization possibilities for our sucrose based excipients?
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