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 and liquids, we manufacture pharmaceutical products in the following dosage forms:

  • 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

For more information about our Specialty Commercial Manufacturing services, fill out the contact form below: