ACIC Pharma Division

In response to customer requests, ACIC 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, ACIC is a truly integrated partner.

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

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

  • Global Regulatory Support
  • Marketing and Sales
  • Manufacturing:
    • Tablets/Capsules
    • Semi-Solids
    • Small Volume Parenterals
    • Large Volume Parenterals
    • Liquid Injectables
    • Lyophilization
    • Sterile Powder Filling
    • Topicals
    • Blow-Fill-Seal

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.

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