Nipro Custom Manufacturing Division

We are uniquely qualified and equipped to provide custom design solutions or completely build to your most demanding drawing specifications. Count on us for our strength in manufacturing the finest quality standard and custom needles in the industry.  Our Corporate Headquarters are located in Osaka, Japan, with our state-of-the-art manufacturing facilities in multiple countries, including Japan. We are a global company that was established in 1954 and have over 29,000 employees.

Factory Capabilities Include:
  • Cannula Forming; Grinding, Polishing & Tube Extrusion
  • Plastic Molding and Extrusion; Injection, Blow & Insert
  • Design, Fabrication, and Validation of tooling and fixtures
  • Automated Assembly; Ultrasonic Welding Solvent, Adhesive, & UV Cure Bonding
  • Packaging; Form, Fill & Seal; Heat Seal Poly Bag & Pouch
  • Sterilization, Shelf Life, and Packaging validation
  • In - House Sterilization; ETO, Gamma, Steam & E-Beam
  • Certified Class 100,000 & Class 10,000 (ISO Class 7 & 8) Clean Rooms
  • Complete Design Engineering, R & D, Prototyping, Testing, Verification, Quality Assurance
  • Regulatory Affairs - support US FDA Pre-market submissions
  • Registered with U.S. Food & Drug Administration
  • ISO 13485; CE Certified; QMS (Japan); cGMP (US FDA QSR)
  • Factory ocean container shipments depart daily to the United States