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Colorants  |   Capsule Manufacturing & ISO Compliance

Regulatory Information on Colorants

This page contains a partial list of general regulatory information related to colorants used with 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.

Colorants Standards
The colorants used by Capsugel in the manufacturing process of capsules comply with the following specifications and guidelines:

Soluble Dyes:

  • Code of Federal Regulations (CFR)
  • As required by the customer, the ability to meet the United States Pharmacopoeia XXIV, European Pharmacopoeia 3rd Edition, or Japanese Pharmacopoeia.

    Titanium Dioxide:

  • Code of Federal Regulations (CFR)
  • As required by the customer, the ability to meet the United States Pharmacopoeia XXIV, European Pharmacopoeia 3rd Edition, or Japanese Pharmacopoeia

    Inks:

  • Code of Federal Regulations (CFR)
  • Only edible inks are used by Capsugel for capsule printing and monogramming.

    Contact Us for information on authorized colorants and specific restrictions for more than 70 countries.

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