Capabilities

Ferro Pfanstiehl is your first choice for cGMP Contract Manufacturing. If you want to outsource the production of chemicals or ingredients, including High Potency Active Pharmaceutical Ingredients (APIs), advanced intermediates, processing aids, or excipients, we offer the facilities, knowledge, and experience you need.

With more than 80 years experience in custom synthesis and process development, we know how to move your product seamlessly from the laboratory into commercialization.

Our comprehensive contract services include:

kilogram to multi-metric ton production under cGMP conditions
process development, scale-up, optimization, and validation
potent drug manufacturing from 1 to 50 Kg (300 gallon) production lots
specialty carbohydrates and blocked sugars
extraction and isolation of specialty carbohydrates
ultra-purification, ultra-filtration, nanofiltration, electrodialysis
cGMP documentation
analytical test method development and validation
ICH compliant stability testing
Drug Master File (DMF) development and maintenance

We work closely and confidentially with pharmaceutical and biotechnology companies that range from small and virtual to multi-national. We produce proprietary and public domain compounds per cGMP guidelines. From a single kilogram for clinical trials to multi-ton commercial quantities, you can trust Ferro Pfanstiehl to help you move your product quickly to market.

For more information, contact us.

cGMP Compliance
With over 40 years of cGMP manufacturing experience, Ferro Pfanstiehl has firmly in place the documentation, validation, and qualification systems to assure compliance with the FDA and other regulatory bodies worldwide. Maintaining more than 20 Drug Master Files (DMF's) for customers and for Ferro Pfanstiehl proprietary drug products, our services include cGMP manufacturing, and cGMP-compliant process development and validation.

Chemical Processes
Ferro Pfanstiehl has a 40-year history in Custom Synthesis / Contract Manufacturing and Process Scale-up Development.

Contract manufacturing
Just tell us the specifics of what you need. We've been providing contract manufacturing services for more than 40 years. We can take your proprietary compound from concept to commercial production, from grams to multi-metric ton quantities.

Custom Synthesis
Ferro Pfanstiehl is expert in complex, multi-step organic synthesis.

Facilities
Ferro Pfanstiehl is the first and only multi-purpose potent compound manufacturer to be certified by the pharmaceutical industry’s leading expert, Safebridge Consultants, Inc.

High-Purity Low Endotoxin Carbohydrates
Ultra-high purity, low-endotoxin carbohydrates are needed when even the lowest level of contaminants — especially endotoxins (cell wall fragments of gram negative bacteria) and other high-molecular weight impurities — can compromise the final product's purity, biological activity, shelf life, and/or patient safety.

Potent Compounds
We produce potent (toxic and cytotoxic) APIs and bulk intermediates in quantities ranging from 1 Kg to 50 Kg (300 gallon) lot quantities. Our 20 years of potent drug experience includes multi-step synthesis of a wide range of organic compounds. We currently maintain 20 active Drug Master Files and manufacture several Ethical and Proprietary Potent API's and Intermediates.