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Pfanstiehl is a global leader in manufacturing high-purity, low-endotoxin, low-metal injectable-grade excipients and bioprocessing components under cGMP standards. These materials support critical applications in bioprocessing, formulation, and specialty pharmaceutical uses.
In addition to its excipient portfolio, Pfanstiehl is a leading contract development and manufacturing organization (CDMO), specializing in the isolation, purification, custom synthesis, and scale-up of small molecule APIs—from gram-scale development to multi-ton commercial production.
Unlike many ingredient suppliers that serve a broad range of industries such as food, cosmetics, or agriculture, Pfanstiehl is exclusively focused on biopharmaceutical applications—demonstrating deep expertise and commitment to this highly regulated sector.
All of Pfanstiehl’s products are manufactured in the USA at its Waukegan, Illinois facility, which adheres to ICH Q7 standards and is inspected and approved by the US FDA. The facility is conveniently located 35 minutes north of O’Hare airport and the city of Chicago.
Established in 1919, Pfanstiehl celebrates its 104-year legacy as a leader in carbohydrate and process chemistry. Our clientele comprises the world’s leading biopharmaceutical, vaccine, and pharmaceutical companies. Our products play integral roles in market-leading drugs addressing life-threatening and debilitating diseases such as cancer, rheumatoid arthritis, STDs, and diabetes, as well as in cutting-edge vaccine platforms, including mRNA, viral vector-based, or traditional protein-based vaccines.
As regulatory and quality standards continue to rise, Pfanstiehl stands out as a trusted partner to the biopharmaceutical and pharmaceutical industries. We are recognized for our high-purity products, rigorous cGMP controls, and strong reputation with global regulatory agencies, including the FDA.
Our commitment to excellence extends beyond product quality—we prioritize environmental responsibility and worker safety. From facility design and equipment to procedures and employee training, we go beyond compliance to exceed FDA, cGMP, OSHA, and international standards.
At the heart of everything we do is an unwavering dedication to product purity, patient safety, and the secure supply of critical Biopharma Excipients.