Company Description
Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients, in gram to multi-ton commercial quantities. We serve such markets as pharmaceutical, biotechnology, veterinary and cosmetics. With over 50 years experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.
Company Background
Founded in 1919, Pfanstiehl will soon celebrate its 100th year anniversary as a leader in carbohydrate and process chemistry. Since under new ownership in 2013, significant investments and improvements continue to be made. Pfanstiehl’s customers include the world’s leading biopharmaceutical and pharmaceutical companies. Our products are utilized in market-leading drugs that treat life-threatening and debilitating diseases, including cancer, rheumatoid arthritis, diabetes, etc., and have been administered to thousands of patients around the world.
Facilities
Pfanstiehl maintains a 10-acre, 160,000 sq. ft., 15-building campus in Waukegan, Illinois USA that provides all the manufacturing, laboratory, warehousing, and administrative operations — all designed to assure the smooth flow of materials and information and to allow production under cGMP.
Services and Capabilities
Pfanstiehl has terrific track record with the FDA! As an API and Excipient manufacturer, Pfanstiehl is inspected regularly by the US FDA. We work diligently to ensure that our facility and systems are inspection ready and compliant with regulatory requirements. As an API manufacturer, FDA inspections of our facility are extensive in nature and cover many segments of our quality system; Production System, Facilities and Equipment Systems, Laboratory Controls System, Materials System, and Packaging/Labeling System. Our recent inspection covered process validation, CAPA, packaging and labeling, materials management, root cause analysis, risk assessment, software validation, 21 CFR Part 11 compliance, and laboratory controls and method development. No FDA Form 483 observations were issued and no Discussion points were made, in the recent FDA audit completed in October 2017. Pfanstiehl’s quality system is based on ICH Q7. We apply the same quality system to our APIs as we do to our Excipients!
