Regulatory
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Global Regulatory Status
USP/NF Listing of Lubrizol's Polymers Global Regulatory Status of Lubrizol's Polymers US FDA Inactive Ingredients StatusProduct Allergen Statements
Noveon® Polycarbophils Carbopol® and Pemulen® PolymersQuality Management System Certificates
Lubrizol Advanced Materials, Inc. Calvert City, KY Lubrizol Advanced Materials Europe Kallo, BelgiumThe above links are in PDF format.
Product Regulatory Information
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)
- European Pharmacopeia (Ph. Eur.)
- Japanese Pharmaceutical Excipients (JPE) Listing
Additionally, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the United States and Europe.
