Generic Pharmaceuticals

ACIC has become an established pharmaceutical partner to oversee the development and manufacturing activities of finished dosage forms with particular expertise in EU dossier conversion, technology / site transfers and custom manufacturing and development.

ACIC is a truly integrated partner with years of experience providing manufacturing technologies and a variety of services to leading pharmaceutical companies worldwide.

ACIC can provide a variety of manufacturing technologies to customers including:

  • Global Regulatory Support
  • Marketing and Sales
  • Manufacturing

ACIC has dedicated sterile and non-sterile facilities for the production of:

  • Pen-Ems
  • Cephalosporins
  • Penicillins
  • High Potency drug products
  • Biosimilars

ACIC 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 Global Regulatory/Technical support

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

For more information, please contact us.

What We Do

  • Tablets
  • Capsules
  • Soft Gels
  • Lyophilization
  • Contract Manufacturing
  • Manufacturing
  • Liquid Injectables
  • Sterile Dry Powders
  • Global Marketing
  • ANDA Preparation and Review
  • Electronic Filing in CTD Format Direct to FDA
  • Pharmaceutical Development
  • Regulatory Consulting
  • Project Management