Regulatory Information on the Capsule Manufacturing Process & ISO Compliance

This page contains a partial list of general regulatory information related to the capsule manufacturing process used to produce our Capsule Products. As laws and regulations vary country by country and their application is often fact-dependent, we strongly suggest that our customers seek expert advice. We are also available (Contact Us) for answers to certain 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 as indicated below:

Contact Us for information on regulatory information.