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.