Product Regulatory Information

Regulatory Lubrizol’s pharmaceutical grade polymers are all manufactured according to cGMP standards in ISO 9001 certified facilities. Lubrizol cGMP compliant facilities are located in Calvert City, Kentucky and Kallo, Belgium.

Lubrizol works with all relevant regulatory bodies in order to establish and maintain the global pharmacopeial status of its pharmaceutical ingredients. Lubrizol ’s pharmaceutical grade carbomers are listed in monographs of the following international compendia:

  • U.S. Pharmacopeia/National Formulary (USP/NF)
  • Japanese
  • European Pharmacopeia (Ph. Eur.)
  • Pharmaceutical Excipients (JPE) Listing (Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph)

Additionally, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the United States and Europe.