Flexibility to Meet our Clients’ Needs
We offer low-cost production of high-quality commercial medicines, with a solid technology base and high quality-assurance standards to deliver supply on time. Our flexible manufacturing systems meet clients’ needs, such as high-mix low-volume manufacturing and Investigational Medicinal Products (IMP). With facilities that specialize in manufacturing solid, semi-solid, and injectable, as well as external-use liquid drug forms, we can develop and manufacture your commercial products, from technology transfer to commercial production. We perform scale-up studies, including process optimization.
Our Edge in Commercial Supply
Flexibility of scale
- Our manufacturing plants in Japan, USA, and South Korea are optimized to accommodate manufacturing at various scales (small to large). We are equipped to support a wide range of drugs, including ethical drugs, OTC drugs, investigational drugs, and quasi-drugs.
In-depth experience in manufacturing
- Our team has deep experience in the qualification and validation of manufacturing facilities, test machines and devices, and manufacturing methods.
- We have a strong reputation due to our diverse, highly reliable technologies that supply quality products to major pharmaceutical companies and our successful site inspections by pharmaceutical companies both in Japan and overseas.
- Contract GMP-compliant manufacturing under strictly controlled conditions
- Cutting-edge facilities and a robust quality assurance system
- Flexible manufacturing lines improve production efficiency
- Efficient and solid technology transfer by our technology staff
- Process optimization, with scale-up studies
- Special handling for injectable products: storage at 2-8° with dedicated power supply
- Manufacturing liquid emulsion ampoules
- Handling biological products
- Inspection, labeling, packaging, etc.
- External use liquid site registered for handling high alcohol drugs (hazardous materials site)
|Solid Form||Tablets||Round, atypical shape|
IR, SR and orally disintegrating (OD)
Core tablet, film coating tablet and sugar-coated
|24-hour operation (automated operation at night)|
|Capsules||#1~5, powder, granule|
|Powders and granules||Plain-fine, taste-masking and more||Inspection: 24-hour operation (automated operation at night), approximately 80k CP/hr with a thorough weight check.|
|Semi-Solid Form||High alcohol containing drugs||Gels and liniments|
Aluminum, laminate or resin tubes (5~190g).
Flammable gel preparation and filling; nitrogen substitution at filling process.
|Semi-Solid Form||Ointments, creams and toothpaste||Aluminum, laminate or resin tubes (5~190g); Jars or cans (5~100g)|
|External-use liquids||Resin bottles (5~50mL), and labeling for resin bottles|
|Suppositories||Sheet of 5 suppositories per sheet. Containers formed by in-line heating of PVC film, with 6 weight types: 0.75g, 1.00g, 1.20g, 1.50g, 2.40g, 2.75g|
|Injectable Form||Final sterilization||Vials||Storage facilities at 2-8° temperatures|
|Final sterilization||Ampoules||Storage facilities at 2-8° temperatures; manufacturing liquid emulsion ampules|
|Aseptic operation||Vials||Storage facilities at 2-8° temperatures|