Regulatory Information on Capsule Products

This page contains a partial list of general regulatory information related to 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 manufactures gelatin capsules from gelatin that complies with the requirements published in:
  The United States Pharmacopoeia (USP); XXIV / National Formulary (NF) 19
  The European Pharmacopoeia (EP); 3rd Edition

• Capsugel provides confidential detailed information about facilities, processes, articles used in manufacturing, processing, packaging, and storing of empty capsules through Type IV (Excipient) Drug Master Files submitted to the Food and Drug Administration in the United States, and equivalent regulatory agencies worldwide.

• Capsugel manufactures gelatin capsules from gelatin that complies with requirements related to Bovine Spongiform Encephalopathy (BSE).

• Capsugel Vcaps capsules of plant origin are Kosher certified, approved by the Vegetarian Society, and upon request, are Halal certified.