Our APIs are manufactured in the US where we specialize in the process scale-up and optimization of generic APIs using cGMP guidance. We work closely with generic drug/pharma companies every step of the way at our world class facilities.
FDA Inspection History
Albemarle Corporation is actively involved in Active Pharmaceutical Ingredient (API) manufacturing, packaging and labeling at two sites, both of which are registered with the United States Food and Drug Administration (US FDA). Albemarle certifies that the methods, facilities and controls used for the manufacturing, processing, packaging and holding APIs conform to current good manufacturing practices (cGMP) in accordance with ICH Guideline Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Certification of the US FDA inspection and cGMP statements for each Albemarle site are listed below.
South Haven, Michigan
Orangeburg, South Carolina
Last Updated: 10/8/2013 11:42:29 AM
Albemarle is a leading specialty chemical company providing innovative chemistry solutions to customers in over 100 countries around the world. We are committed to creating value for our shareholders, customers and employees, while continually striving for excellence by doing the right things the right way.
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