Manufacturing Services

AuroSource offers flexibility with five accredited API development and manufacturing facilities, most being USFDA, MHRA, Health Canada, TGA, ANVISA and SA MCC accredited. Our ability for regulatory filings from multiple sites coupled with global warehousing locations ensures business continuity for our customers with shortened 'order to delivery' times.

  • In stability studies offerings we have efficiently implemented global stability protocols 21CFR part 11 compliant LIMS for stability analysis.
  • Walk in chambers for all ICH conditions with chamber capacities up to 100,000 Litres. Continuous automated monitoring of all stability chambers.
  • State-of-the-art manufacturing facilities bolster our proficiency in GMP and non-GMP processes allowing us to extend a highly competitive edge to each of our customers with API manufacturing needs.
  • Our manufacturing services cover your needs from R&D to plant scale material for clinical trials, right up to more specialized capabilities including commercial scale chromatographic separation and lyophilization. We offer six modern scalable facilities with a total reaction volume in excess of 4,500 cubic meters.