Flexibility to Meet our Clients’ Commercial Supply Needs

CMIC’s commercial supply capabilities 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)

Commercial Supply and Production Capabilities

Dosage Forms Type Specifications Capacity
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
Manufacturing

Development and Manufacturing

Formulation Process Analytical Development

Formulation, Process and Analytical Development

Packaging and Labeling

Packaging and Labeling

Release and Stability

Release and Stability Testing

Tech Transfer

Technology Transfer

Consulting Services

Consulting Services

CMC Consulting

CMC Consulting Services

Connect with CMIC