AMPAC Fine Chemical LLC


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916-357-6921
916-747-0221
Hwy 50 & Hazel Avenue
Rancho Cordova, California 95670

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Regulatory Compliance

Regulatory Compliance and Quality Assurance

The design and operation of AFC’s production facilities comply with U.S. Federal, State of California and other worldwide regulatory requirements for the production of pharmaceutical chemicals in accordance with cGMPs.

AFC’s regulatory status is maintained via comprehensive, compliant quality systems. The U.S. Food and Drug Administration (FDA) and other U.S.-based regulatory authorities, as well as the Pharmaceuticals and Medical Device Agency (PMDA) in Japan, have audited us routinely with excellent results. In addition to meeting the highest regulatory standards for our own operations, we offer our clients additional services that include:

  • Drug Master Files (DMFs) preparation and maintenance
  • Input and review of Chemistry, Manufacturing & Controls (CMCs) sections of New Drug Applications (NDAs)
  • Development and Validation of Analytical Methods
  • Stability and Microbiology Testing
AFC’s Quality Control laboratories are fully equipped with the latest analytical equipment to support production and ensure the highest level of quality in the final product:
  • Gas Chromatography (GC) — Static Headspace/Gas Chromatography (HS/GC) — Gas Chromatography/Mass Spectrometry (GC/MS)
  • High-Performance Liquid Chromatography (HPLC)
  • Liquid Chromatography/Mass Spectrometry (LC/MS)
  • Ion Chromatography
  • Nuclear Magnetic Resonance (NMR) (300 MHz)
  • Fourier Transform Infrared (FTIR) — Ultraviolet-Visible Spectroscopy 
    (UV-VIS) — Polarimeter
  • Particle Size Analyzer
  • Differential Scanning Calorimetry (DSC)/Thermogravimetric 
    Analysis (TGA)/RC-1

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Ampac Fine Chemicals.
Rancho Cordova, CA 95741-1718
Tel 888 330-2232
Intl Tel +1 916 357 6880
Fax +1 916 353 3523
Email Afcbusdev@apfc.com

AMPAC Fine Chemicals Rancho Cordova, California 95941-1718 At AFC, we consistently provide our
customers with cutting-edge
technology-driven solutions for
reduced time-to-market.