Regulatory Information on the Capsule Manufacturing Process & ISO Compliance

As laws and regulations vary country by country and their application is often fact-dependent, please contact us for regulatory information related to the capsule manufacturing process used to produce our Capsule Products or for answers to other regulatory questions.

• Capsugel capsules are manufactured under controlled climate conditions in accordance with applicable cGMP (current Good Manufacturing Practices) standards, using a dipping process on high-capacity automatic machines.
• Imprinting 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, as a standard, does not use sulfur dioxide or ethylene oxide for preventing or eliminating microbial growth.
• All Capsugel two piece gelatin manufacturing facilities have met the requirements for ISO (International Standards Organization) registration.

Contact Us for information on regulatory information.