AMPAC Fine Chemicals (AFC) is a leading US-based custom manufacturer of Active Pharmaceutical Ingredients (APIs) and registered intermediates with state-of-the-art facilities in California and Texas. Led by an experienced team of chemical and engineering experts, we support our partner’s clinical to commercial stage programs through process R&D, a unique set of enabling technologies, and cGMP manufacturing from kilogram to multi-ton scale.
These enabling technologies include handling hazardous materials and performing highly energetic reactions, controlled substance and high-potency compound manufacturing, chromatographic separations, and continuous flow processing.
Strict adherence to cGMP and strong quality systems effectively underpin our regulatory compliance. AFC also an extensive history of successful pre-approval inspections (PAIs) performed by the FDA prior to commercial manufacture of our customer’s new APIs.. Continuous cost reduction and secure sourcing also serves to enable our customer’s success.
We welcome customer inquiries and visits to our facilities.
Product Categories
Allied Services
- API Manufacturing, Synthesis
- Custom Chemical Manufacturing, Synthesis
- Extraction & Purification, Chemical
- Fine Chemical Manufacturing
- Pharmaceutical Intermediate Manufacturing
- Process Optimization, Chemical
- Scale-up, Custom Chemical
What is Your Company's Primary Activity?
- Biopharma
- Pharmaceuticals