Active Pharmaceutical Ingredients

GSI Pharmaceuticals's API Division offers a wide range of bulk products through our Open World Network.

Product Listing

Please note that list is by no means exhaustive and many of these products are in various stages of development. We invite you to contact us about these or any other products you may be seeking.

Product Request Form

GSI Pharmaceuticals manufactures, supplies and sources, on an exclusive basis, an extensive range of Active Pharmaceutical Ingredients from cGMP and FDA inspected manufacturers.

Everyone knows the path from molecule to market. The challenge is to find the fastest and most efficient way worldwide. The GSI Pharmaceuticals approach is designed to help you arrive at the most efficient solutions by offering you to a wider range of global choices.

GSI Pharmaceuticals has helped many different leading Active Ingredient manufacturers gain access to world markets – especially the hard to penetrate Asian, Canadian and E.U. markets.

GSI Pharmaceuticals can provide manufacturing partners with first-class sales and product representation and regulatory approval management. DMF / eDMF / PR-DMF as well as NDA, ANDA (USA) and C.N.O.R. (Canada) and European documentation preparation including ongoing strategic marketing advice.

GSI Pharmaceuticals has experience and resources for:

  • Site Transfer
  • Sales & Acquisition of Facilities
  • Electronic CTD Format
  • Regulatory Submission
  • Regulatory Interpretation
  • Patent Applications
  • Marketing and Sales

Some of the key Therapeutic Categories where GSI Pharmaceuticals is most active in:

  • HIV
  • Protease Inhibitors
  • Antibiotics
  • Anti-infectives
  • Anti-diabetics
  • Gastrointestinal
  • Cardiovascular
  • CNS

Custom Manufacturing & Outsourcing Capabilities

GSI Pharmaceuticals can facilitate in all stages of API development. Ask GSI Pharmaceuticals for help with opportunity identification and validation, process development, scale-up and commercialization. Our partner companies have many products in development at any given time that can be made available to customers at an early stage.

GSI Pharmaceuticals extensive experience in the synthesis of Active Pharmaceutical Ingredients is coupled with the wide capability range in over 50 US-FDA inspected plants and other plants in the process of obtaining approvals. Our experience in building plants (five), streamlining plants for FDA inspection (forty) and organizing R&D groups (four), along with our extremely close working relationships with these facilities, allows us the flexibility to manufacture almost any kind of fine chemicals. (Fermentation – Synthesis - Extraction).

Since 2001, we have accumulated an international experience in the following areas of both Synthesis & Fermentation:

  • Process Research
  • Process Development
  • Analytical Development
  • Clinical Quantities under GMP and validated
  • Pilot Scale-Up
  • Process Optimization
  • Production Validation
  • Regulatory Support
  • Manufacturing Scale-up and Industrial Production

Our intimate knowledge of the strengths and weaknesses of each partner plant enables us to select the best site for manufacturing. Partnering with us would give you the utmost flexibility and efficiency from grams to tonnage.

GSI Pharmaceuticals offers a wide variety of customizations through its Global Network. However, this list is by no means inclusive and we invite you to contact us about any other custom manufacturing requirements you may have in the areas of Custom Organic Synthesis & Fermentation.