With an extensive compliance program focused on meeting the strictest international regulatory requirements for capsules and finished dosage forms, we work openly to maintain the trust of our customers as part of our transparent and collaborative approach.
Although our empty capsules are designed to be globally acceptable, specific regulations applicable for the intended application in the anticipated target markets can be important when choosing the right capsule. Capsugel can help you in selecting the qualitative and quantitative composition in order to meet the regulatory requirements of all your target markets. Upon ingredient selection and product formulation, Capsugel carefully considers applicable labeling legislation which ensures high level of health protection for consumers and guarantees their right to information. Therefore, Capsugel composition sheets and available technical information provides the necessary information for your compliant finished product labeling.
Our capsule release requirements comply with purity and microbiological specifications that apply to the capsules’ end use as food supplements and pharmaceutical excipients. Our validated test methods contribute to a comprehensive release process, allowing customers to be confident in the quality of the capsules they receive.
In addition, Capsugel carefully selects and qualifies its transporters and through documented quality requirements, makes them aware of the product capsule type and required conditions. This final step is part of our commitment to conduct our business with the highest integrity and in compliance with all regulatory and legal standards.