For more than 40 years, Ferro Pfanstiehl Laboratories a wholly-owned subsidiary of Ferro Corporation, manufactures clinical and commercial quantities of active pharmaceutical ingredients (APIs), highly potent or highly cytotoxic active pharmaceutical ingredients (HPAPIs), advanced intermediates, and other small molecule new chemical entities (NCEs).
The FPL site is FDA registered, inspected and approved, with a very successful audit history (FDA General Inspection Q3 2010 with no 483s, 30+ annual client audits). FPL was the first company to receive Safebridge Certification for its HPAPI containment facilities.
FPL’s commitment to quality and safety allow us to meet or exceed client needs and produce high quality drug compounds for distribution all over the world. FPL holds more than 15 active U.S. and international DMFs and produces three commercial nucleosides and several clinical drug candidates today.
FPL’s focus is delivering value throughout the product lifecycle from clinical trial materials to commercial production with outstanding technical support. FPL’s staff supplements your team with years of experience in scale-up, process chemistry, methods development, process validation and regulatory affairs. We offer the following value added services.
In addition to custom API and NCEs, FPL is known as the world’s leading supplier of specialty and blocked sugar high purity lowendotoxin (HPLE), carbohydrates, produced under API-level cGMP, ICH-Q7A compliant conditions. FPL manufactures HPLE sugar Excipients including versions of Sucrose, Trehalose, Maltose, Galactose and non animal derived Galactose for injectable products and ingredients for use in today’s risk-based regulatory environment.
Please contact: Business Development for more information