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. We 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, Lonza 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.
addition, Lonza 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.