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QUALITY

Quality has always been and will continue to be the cornerstone of Nexgen Pharma. Our commitment to quality is reflected in every product we manufacture.

Each pharmaceutical product undergoes rigid process validation, stability-indicating method validation, and method development protocols during each manufacturing and analytical process.

Our manufacturing processes follow the highest standards and our quality assurance and control procedures are stringent. Nexgen adheres to the strict standards of the current Good Manufacturing Practices (cGMPs) established by the US Food and Drug Administration. We test and analyze raw materials, products in production and finished goods using advanced analytical techniques such as capillary electrophoresis, UV/visible spectrophotometry, infrared and near-infrared spectrophotometers, high pressure liquid chromatography, gas chromatography, ICP-MS, GC-MS and microbiological testing where appropriate.

Our adherence to exacting quality assurance and quality control standards assures you that your precise product specifications are consistently met.

Analytical equipment includes:

  • · Capillary Electrophoresis (CE)
  • · Gas Chromatography (GC)
  • · Gas Chromatography - Mass Spectrophotometry (GC-MS)
  • · High Pressure Liquid Chromatography (HPLC)
  • · Induction Coupled Plasma - Mass Spectrophotometry (ICP-MS)
  • · UV Spectrophotometers (UV)
  • · Nondestructive Infrared Spectrophotometers (IR)
  • · Near-infrared Spectrophotometers (near IR)
  • · Dissolution Apparatus
  • · Various instrumentation for monograph testing
  • · Microbiological testing equipment and analysis
  • Nexgen can provide services including: methods development, method validation, stability testing, comparative dissolution testing, as well as raw material, in-process and finished goods analysis.