Founded in 1919 by Carl A. Pfanstiehl, our company specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin (HPLE) Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients (API’s), in gram to multi-ton commercial quantities.
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Pfanstiehl is known as the world’s leading supplier of high purity low endotoxin carbohydrates produced under API-level cGMP, ICH-Q7 compliant conditions. Pfanstiehl manufactures HPLE sugar-based excipients including versions of Sucrose, Trehalose, Maltose, Galactose for injectable products and ingredients for use in today’s risk-based regulatory environments.
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Pfanstiehl is a cGMP small molecule API manufacturer 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.
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Pfanstiehl’s is organized along five key Centers of Excellence: Process Chemistry, cGMP Manufacturing, Project Management, Analytical Services, & Quality/Regulatory Compliance. Our special capabilities include process development/scale-up; process validation; stability testing; test method development and validation; and drug master file development and maintenance.
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