Generic Active Pharmaceutical Ingredients
Albemarle enjoys a long history of supplying high-quality active pharmaceutical ingredients (APIs) to the ethical and generic API pharmaceutical manufacturing markets.
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
Albemarle Europe, Middle East, Africa
EMA Fine Chemistry Services
Tel: +32 10 48 1711