Clinical Supply Manufacturing

Current Good Manufacturing Practices (cGMPs) are regulations established by the U.S. Food & Drug Administration (FDA) that apply to the methods, equipment, facilities and controls required for manufacturing pharmaceuticals and other products.

IriSys has demonstrated expertise and compliance with cGMP regulations for the manufacturing of pharmaceutical formulations for clinical trials and specialty pharmaceutical products. We have the experience and capacity to manufacture a wide range of dosage forms in our state-of- the-art facility in San Diego.

cGMP clinical supplies

We provide packaging and labeling for:

  • Vials
  • Sterile fill syringes
  • Bottles
  • Over encapsulation
  • Blister packaging
  • Bulk packaging
  • Bulk labeling
  • Sachets
  • Powder in bottle

Dosage forms

We manufacture pharmaceutical products in dosage forms needed by our clients.

  • Capsules, hard gelatin or HPMC (hydroxypropyl methyl cellulose), liquid-filled
  • Capsules, hard gelatin or HPMC, powder-filled
  • Capsules, controlled or sustained release
  • Tablets, immediate release
  • Tablets, controlled or sustained release
  • Tablets, enteric-coated
  • Topical gels, creams, ointments
  • Oral liquids
  • Over-encapsulation
  • Injectables, including lyophilization

Specialty Commercial Manufacturing

IriSys’ expertise includes specialty commercial manufacturing of single source products and registration batches for Abbreviated New Drug Applications (ANDAs), formulations for rare diseases and orphan drugs. We have a successful track record with a wide range of therapeutic agents having varied physicochemical properties.

Process improvement and validation

Our services include:

  • Formulation and process optimization of drug product
  • Scale up from R&D to commercial cGMP batch manufacturing
  • Process validation
  • Technology transfer

Solid oral dosage forms & liquids

We manufacture pharmaceutical products in the following dosage forms:

  • Tablets (immediate, extended and delayed release)
  • Liquid-filled capsules
  • Powder-filled capsules (immediate, extended and delayed release)
  • Oral liquids
  • Injectables, including lyophilization (volumes up to 10,000 units)