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:
Additionally, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the United States and Europe.
USP/NF Listing of Lubrizol's Polymers
Global Regulatory Status of Lubrizol's Polymers
US FDA Inactive Ingredients Status
Not all Carbomers are Created Equally
IID Listings Applicable to Pharmaceutical Polymers for Oral Application
Pharmaceutical Allergen Statement
GMP Compliance - Calvert City KY