At Capsugel, we are committed to being the foremost partner and leading supplier of innovative dosage forms and solutions to the healthcare industry. With our rigorous regulatory monitoring and quality systems, our customers can be assured that the raw materials, colorants and other ingredients used in hard empty capsules meet applicable standards with minimal risk of recalls or sanctions.
To that end, Capsugel provides a Certificate 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 in accordance with established specifications. As a result of our strict manufacturing and certification process, many customers are able to significantly reduce incoming QA testing based on information supplied in the Certificate of Analysis.
Additionally, 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.
As a leading supplier of innovative dosage forms, we manage dozens of custom formulation projects, from solubility enhancement to taste masking, that meet the needs of specialized markets. This includes capsule ingredient products for Kosher and Halal markets and non-animal ingredients in capsules for vegetarian consumers. Our HPMC based capsules are suitable for use with organic dietary supplements in Europe while in the United States, our pullulan capsules are approved for use with organic ingredients in order to accommodate “made with organic ingredients” label language.
Capsugel is a global leader in capsule development and manufacturing. With a diverse portfolio, including hard gelatin, softgel and vegetarian capsules, many of our products meet consumer and patient needs around the world.
Capsugel empty capsules are “non-GMO” and are not produced from nor contain genetically modified organisms (GMOs). Several of our products are independently verified under third-party non-GMO verification program to a standard, based on avoiding GMO contamination based on careful source material selection, testing, and identity preservation into the supply chain.
The Non-GMO Project is North America’s only third-party verification and labeling for non-GMO foods and products.
Verification requires ongoing testing and ensures rigorous traceability and segregation practices are followed in order to meet finished product integrity.
Capsugel products such as DRcaps® capsules, Vcaps® capsules, Vcaps® Plus capsules and Plantcaps® capsules are certified by the Vegetarian Society of UK and the Vegan Action organization of the United States. That means they are certified free from animal-derived ingredients and are cruelty-free with no animal testing.
Capsugel offers kosher capsule certification for empty gelatin and vegetarian capsules. Consult with Capsugel’s Customer Service Organization for specifics related to the kosher certifications.
Capsugel offers Halal certification for capsule products made from bovine gelatin and vegetarian polymers. Consult with Capsugel’s Customer Service Organization for specifics related to the Halal certifications.