Our laboratory facilities are equipped to test clinical trial material and commercial product for release and stability testing. Analytical experts provide full support, to ensure your product is stable for customer use, prior to release. Our labs in Japan, South Korea, and the U.S. have analytical equipment for quality control and stability validation support.
Our Edge in Release and Stability Testing Laboratory Facilities
Quality assurance
- Reliable quality control system which supplies products to major pharmaceutical companies. We have received high evaluations during domestic and foreign pharmaceutical companies’ inspections.
Services and Equipment
- Largest industry sample storage area
- Large volume storage chambers for infusion and dialysis fluid
- Chemical hazard rooms
- Residual solvents testing room
- Low humidity testing room
- Deep freezers for ultra-low frozen storage (-20 to -40°C, -30 to -50°C and -70 to -90°C), with temperature control systems and independent electrical generators]
- Storage at ambient room temperature (15-25°C), refrigerated (2-8°C), and frozen (-15 to -25°C)
- Custom conditions/validations to meet study needs
Facility | Product/Dosage Type | Packaging Types |
CMIC CMO Co., Ltd. IP Manufacturing Facility | Blister pack | Primary packaging, oral dose |
Pillow packaging | Primary packaging, oral dose | |
Bottle | Primary packaging, oral dose | |
Sachet | Primary packaging, oral dose | |
Labeling | Secondary packaging, oral dose | |
Labeling | Secondary packaging, vials & syringes, room temperature | |
Labeling | Secondary packaging, vials & syringes, 2-8° | |
Randomized Labeling | Labeling | |
Japan Shizuoka Plant | Tablets | Packaging, oral dose |
Capsules | Packaging, oral dose | |
Powders/granules | Packaging, oral dose | |
Injectables | Secondary packaging, vials and syringes | |
Japan Toyama Plant | Topicals | Packaging, ointments and creams |
Topicals | Packaging, topical liquids | |
Topicals | Packaging, gels | |
Topicals | Packaging, suppositories | |
Solid dosage | Packaging, oral dose | |
Japan Ashikaga Plant | Tablets | Packaging, oral dose |
Capsules | Packaging, oral dose | |
Powders/granules | Packaging, oral dose | |
Injectables | Packaging, vials and syringes | |
Ampoules for biologics and small molecules | Packaging, sterile solutions | |
Japan Nishine Plant | Tablets | Packaging, oral dose |
Capsules | Packaging, oral dose | |
U.S. New Jersey Plant | Tablets | Packaging, oral dose |
Capsules | Packaging, oral dose | |
Powders/granules | Packaging, oral dose | |
South Korea Gyeonggi-do Plant | Liquids | Packaging, topical liquids |
Semi-solids | Packaging, ointments, gels and creams |