Regulatory Assistance

We can help ease go-to-market regulatory concerns with the highest quality standards and our compliance know-how.

Global Compliance Standards

Whether you need to respond to changing global demand or enter new and emerging markets to stay competitive, our insight into regulatory compliance can help you achieve your goals.

Capsugel products and manufacturing facilities conform to the highest worldwide quality and regulatory standards:

• Certificate of Analysis – As part of our commitment to world-class quality, Capsugel provides a Certificates of Analysis with every capsule order. This includes the specific details and test results of each lot of capsules, certifying the manufacture of these capsules is in accordance with established specifications. Many customers are able to significantly reduce incoming QA testing based on information supplied in the Certificate of Analysis.

• Regulatory Information on Colorants – We’re known for our extensive expertise in the global use and regulation of colorants. We only use colorants that comply with the U.S Code of Federal Regulations (CFR), and that meet United States Pharmacopoeia XXIV, European Pharmacopoeia 3rd Edition, or Japanese Pharmacopoeia standards as required by you, our customer. Our experts will meet with you throughout the development process to ensure compliance on a market-by-market basis.

Products Standards

• Only pharmaceutical-grade gelatin is utilized in Capsugel brand capsules, enabling our capsules to meet all worldwide Pharmacopoeia standards
• Capsugel provides confidential detailed information about facilities, processes, articles used in manufacturing, processing, packaging, and storing of empty capsules through Type IV (Excipient) Drug Master Files submitted to the Food and Drug Administration in the U.S., and equivalent regulatory agencies worldwide
• Capsugel manufactures gelatin capsules from gelatin that complies with bovine spongiform encephalopathy (BSE) requirements
• Capsugel Vcaps®, Vcaps® Plus and NPcaps® capsules are made of plant origin, are Kosher certified, approved by the Vegetarian Society, and upon request, are Halal certified

Manufacturing Process Standards & ISO Information

• Capsugel capsules are manufactured under controlled climate conditions in accordance with applicable cGMP standards, using a dipping process on high-capacity automatic machines
• Printing of the pre-closed capsules, if desired by the customer, is undertaken before the capsules are transferred to final packaging
• Due to the high quality of its manufacturing conditions, Capsugel, does not use sulfur dioxide or ethylene oxide for preventing or eliminating microbial growth
• All Capsugel two-piece capsule manufacturing facilities have met the requirements for ISO (International Standards Organization) registration

As laws and regulations vary by country and their application is often fact-dependent, please contact us for detailed information related to the capsule manufacturing process used to produce our capsule products. And as always, Capsugel strongly suggests you seek expert regulatory advice.