GSI Pharmaceuticals Division

In response to the requests of our customers, GSI Pharmaceuticals has established a Pharma Division to oversee the development and manufacturing activities of finished dosage forms.

With particular expertise in EU dossier conversion, technology/site transfers and custom manufacturing/development, GSI Pharmaceuticals is a truly integrated partner.

GSI Pharmaceuticals can assist manufacturing facilities whether FDA inspected, or in the process of triggering inspection.

GSI Pharmaceuticals can provide a variety of manufacturing technologies to customers including:

  • Formulation Development
  • Manufacturing
  • Tablets/Capsules
  • Semi-Solids
  • Small Volume Parenterals
  • Large Volume Parenterals
  • Liquid Injectables
  • Lyophilization
  • Sterile Powder Filling
  • Topicals
  • Blow-Fill-Seal

GSI Pharmaceuticals also has dedicated sterile and non-sterile facilities for the production of:

  • Cephalosporins
  • Penicillins
  • High Potency drug products

GSI Pharmaceuticals can provide the following services to customers:

Formulation R&D

  • Literature surveys and comparative brand studies
  • Raw material sourcing (API, excipients)
  • Production of trial batches
  • Testing of physical and core parameters
  • Stability testing

Method Development & Validation of Analytical Methods

  • API characterization
  • Excipients testing
  • Reference product characterization
  • Method validation
  • Cleaning validation

Manufacture of Drug Product

  • Drug product in-process testing
  • Finished product release testing
  • Cleaning verification
  • Packaging
  • Stability testing

Technology Transfers

Clinical and Bio-analytical support

  • Pilot and pivotal BE studies
  • Dissolution Testing

In-house regulatory/technical support

  • Electronic CTD format dossiers
  • ANDA, NDA, ANDS, MA, etc.

Please contact us to learn more about the drug products/dossiers we have available in your region and to discuss your project.