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ACIC Pharma Division
In response to the requests of our customers, ACIC has established a Pharma Division to oversee the development and manufacturing activities of finished dosage forms.
With particular expertise in custom manufacturing and technology transfers, 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 testing
- Cleaning verification
- Packaging
- Stability testing under accelerated and controlled conditions
Technology Transfers
Clinical and Bio-analytical support
- Pilot and pivotal BE studies
- Dissolution Testing
Full regulatory/technical support
- CTD format dossiers (eCTD coming soon)
ACIC can provide a variety of manufacturing technologies to customers including:
- Wet granulation
- Dry granulation
- Tablets
- Pelletization
- Capsules
- ER/MR/DR tablets and capsules
- Sterile powder filling
- Lyohilization for injectables
- Small and large volume parenterals
- Semi-solids
- Blow-Fill-Seal ophthalmics
Besides general, multipurpose manufacturing sites, ACIC also has dedicated sterile and non-sterile facilities for the production of:
Cephalosporins
Penicillins
High containment drug products
For a list of ACIC’s products, please click here.
To discuss your project, please contact:
Jesse Ledger
Business Development, Pharmaceuticals
519-751-3668 ext. 7275
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