API’s, Kg-SCALE

PharmAgra Labs economically develops and manufactures low-volume commercial API’s in the United States at our FDA-inspected facility.

Since 2009 PharmAgra Labs, Inc. has been a manufacturer of low-volume (mg-kg) clinical and commercial Active Pharmaceutical Ingredients (FDA-inspected site #3004872718).  The primary industries we serve are Pharmaceutical (oral, injectable, ophthalmologic, dental, etc.) and Medical Devices.  All PharmAgra operations are conducted in the USA at our Brevard, NC facility.

If your production requirements exceed our in-house capabilities, we have working relationships with several domestic and offshore large-scale manufacturers. We can also provide technology transfer services to clients who want to work directly with their manufacturers.

Related services include:

  • In-house production (mg-kg scale) using client-provided or PharmAgra-developed processes
  • Manufacture of up to MT quantities using domestic or offshore collaborators
  • Technology transfer to client-specified domestic or offshore manufacturers
  • Analytical methods development/validation
  • Process development/validation
  • cGMP/GLP analysis, product release testing
  • Analytical standards
  • Related substances/impurities/unknowns identification, synthesis and characterization
  • Separation and identification of complex mixtures (optical isomers, geometric isomers, etc.)
  • Chemical conversion/derivatization in support of difficult analytical determinations
  • Analysis and interpretation using HPLC-DAD/ELSD, GC (MSD/FID), LC/MS, 400 MHz NMR (1H, 13C, 19F, 31P), FT-IR, etc.
  • ICH/non-ICH stability studies