Pfanstiehl is a leading US manufacturer of cGMP-produced components for use in upstream and downstream bio/pharma formulation applications. Pfanstiehl is a cGMP CMO for small molecule API manufacturing specializing in carbohydrates, nucloeosides, and new chemical entities (NCE's). Pfanstiehl also manufactures generic API's such as Streptozotocin and Cytarabine and has several new products under development. In addition, Pfanstiehl offers large volume parenterals including sodium and ammonium lactates.
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.
Our custom services include:
•Custom synthesis of Active Pharmaceutical Ingredients and advanced intermediates •Process development/scale-up •Process validation •Stability testing •Test method development and validation •Clinical Trial Material (CTM) and supporting documentation •Drug Master File (DMF) development and maintenance
Working closely with clients ranging from virtual pharmaceutical companies to the world’s largest multinational pharmaceutical and biopharmaceutical producers, we synthesize proprietary and commercial compounds in quantities ranging from grams to tons. Manufacturing and development take place within a 13-building campus located near Chicago, Illinois.
Unlike many firms who claim cGMP or are simply resellers, Pfanstiehl manufactures their products themselves, in the US, and in an API-level cGMP, ICH Q7 compliant facility.