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.

Services

  • 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)

Capabilities

Dosage FormsTypeSpecificationsCapacity
Solid FormTabletsRound, 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 granulesPlain-fine, taste-masking and moreInspection: 24-hour operation (automated operation at night), approximately 80k CP/hr with a thorough weight check.
Semi-Solid FormHigh alcohol containing drugsGels and liniments

Aluminum, laminate or resin tubes (5~190g).

Flammable gel preparation and filling; nitrogen substitution at filling process.

Semi-Solid FormOintments, creams and toothpasteAluminum, laminate or resin tubes (5~190g); Jars or cans  (5~100g)
External-use liquidsResin bottles (5~50mL), and labeling for resin bottles
SuppositoriesSheet 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 FormFinal sterilizationVialsStorage facilities at 2-8° temperatures
Final sterilizationAmpoulesStorage facilities at 2-8° temperatures; manufacturing liquid emulsion ampules
Aseptic operationVialsStorage facilities at 2-8° temperatures

Development and Manufacturing

Formulation, Process and Analytical Development

Packaging and Labeling

Release and Stability Testing

Technology Transfer

Consulting Services

CMC Consulting Services