For more than 40 years, Ferro Pfanstiehl Laboratories (FPL) Inc, a wholly owned subsidiary of Ferro Corporation, has manufactured clinical and commercial quantities of active pharmaceutical ingredients (APIs), high potency, high containment APIs, advanced intermediates, and other small molecule new chemical entities.
The FPL site is FDA registered, inspected and approved, and client audited on a regular basis, while the company has also received SafeBridge Certification. Its focus on safety and quality enables it to handle compounds in a secure environment.
The company holds more than 15 active US and international Drug Master Files. It focuses on delivering value throughout the product lifecycle, from clinical trial materials to commercial production with outstanding technical support. FPL’s staff supplements its clients’ teams with experience in scale-up, process chemistry, methods development, validations and regulatory affairs. It is on this platform that the company offers the following products and services:
- fee for service and contract manufacturing of APIs, cytotoxic and potent drugs and advanced intermediates and linkers
- contract manufacturing services for high purity carbohydrates and excipients, sugar acids, esters, alcohols, lactones and salts, and pharmaceutical-grade salt solutions
- method development, process and cleaning validation for stability testing, and clinical trial material with supporting documentation
- DMF preparation, submission and maintenance.
FPL is also a leading supplier of speciality and blocked sugars of high purity low endotoxin (HPLE) carbohydrates produced under APIlevel cGMP, ICH-Q7A compliant conditions. The company 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 riskbased regulatory environment.