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About contract manufacturing business activities of Nagase Medicals Concentration of technologies on realization of high quality, cost-effectiveness and timeliness

Nagase Medicals has positioned the contract manufacture business centered on manufacturing technologies for spray drying and sterile products, including high-potency pharmaceuticals such as anticancer drugs, as a key pillar of our business. We have already garnered a reputation for high reliability through the services we have rendered for clients including major Japanese and international pharmaceutical companies.

Under the close cooperation of the manufacturing, quality assurance and R&D departments, we can precisely meet the diversified needs of customers across a wide range of services?from investigation of possible formulations and formulation design, through to securing regulatory approval and validation, and achieving commercial-scale production.

We can handle pilot production at the stage of development and clinical trials as well as small-lot production, and we operate a management system compliant with PIC/S GMP principles.

  • 1. contract manufacturing of injections
  • 2. contract manufacturing of liquid preparations
  • 3. contract manufacturing of spray dry manufacturing processes
  • 4. contract manufacturing of quasi-drugs, cosmetics and health food products
  • 5. Entrusted R&D activities and quality assurance system
Manufacturing system

1. High-Potency Pharmaceutical Products
  Manufacture using high-level containment technology suitable for exposure levels (OEL) as low as 0.1ƒĘg/m3
  Prevention of cross contamination through a single-use system
  Manufacture and quality control of injection products using aseptic processing compliant with PIC/S GMP principles
  Aseptic filling of both glass and resin vials
  Development, investigational drug manufacture and commercial manufacture of liposome formulations
  Shrink label wrapping to prevent vial breakage
2. General Pharmaceutical Products
  Manufacture and quality control of injection products using aseptic processing and terminal sterilization
  Development, manufacture and contract manufacture of glass vials and ampoules
  Development, manufacture and contract manufacture of liquid and jelly formulations in which bacteria are controlled
3. Spray Drying Manufacturing Technology
  One line for pilot production and two lines for commercial production housed in a dedicated GMP-compliant building
  One set of equipment for laboratory-scale manufacturing, able to handle from the R&D stage through to commercial production
4. Cosmetics and Health Foods
  Utilizing our pharmaceutical manufacturing technology, we can offer development, manufacture and contract manufacture of adjuvants used for medical purposes (for liquid formulations), quasi-drugs, cosmetics and health foods

Overview of our plant
General Finished Dosage Factory Steel-frame 4-story building, Floor Space :  3,893 m2
Injections Factory Building Floor Space :  260 m2
Oncology Injections Factory‡U Building Floor Space :  950 m2
Spray-dry Factory Building Floor Space :  1,279 m2
Health Food and Cosmetics
Factory (2 buildings)

Building Floor Space :  722 m2

Quality Control Building

Building Floor Space :  538 m2

Laboratory building

Building Floor Space :  625 m2

Warehouses (3 buildings)

Building Floor Space :  1,420 m2;
Storage capacity :  1700 PL

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