We Are Pfanstiehl

Pfanstiehl is globally recognized as a leader in manufacturing cGMP high-purity, low-endotoxin, low-metal injectable-grade excipients and biopharmaceutical components for various applications in bioprocessing, formulation, and specialty areas. Additionally, Pfanstiehl operates as a prominent contract development and manufacturing organization (CDMO), specializing in the isolation, purification, custom synthesis, and scale-up development of small molecule Active Pharmaceutical Ingredients (APIs) ranging from gram to multi-ton commercial quantities. While many ingredient manufacturers or resellers cater to various industries like food, cosmetics, agriculture, and nutritional supplements, providing only a limited range of “pharma-grade” ingredients, Pfanstiehl’s exclusive focus lies in Biopharma applications, demonstrating a dedicated commitment to this specific sector.

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Made in the United States of America

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.

100+ Years of Innovation

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.

Quality, Purity, Safety

Increasing regulatory and quality demands favor high-integrity biopharmaceutical and pharmaceutical manufacturers like Pfanstiehl, known for their high-purity products, robust cGMP controls, and trusted reputation with regulatory agencies like the FDA. At Pfanstiehl, our work is driven by a commitment to both product quality and environmental/worker safety. We meticulously design and equip our facilities, draft procedures, and train our workforce to not only meet but exceed US FDA, cGMP, OSHA, and international regulatory and multi-compendial standards. Quality, purity, and safety of patients, along with ensuring the security of critical Biopharma Excipients, constitute the core values of Pfanstiehl, to which we are deeply committed.