Certifications & Registrations

Namicos holds the following quality and compliance certifications:

ISO13485

  • Certified on September 27, 2021
  • Internationally recognized standard for quality management system with respect to the medical device industry

ISO15378

  • Certified on May 24, 2018 (this replaced the ISO9001 certification held from 2001 – 2018)
  • Primary packaging materials for medicinal products – particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

US FDA DMFs

  • Glass ampoule DMF No. 15076
  • Silicone coating DMF No. 15330
  • Cleaning processing DMF No. 20667

Other DMFs

  • Health Canada: Cleaning processing DMF No. 2007-252
  • CDE (China): Ampoule (clear) No. B20190001022
  • CDE (China): Ampoule (amber) No. B20190001023

Qualifications

Qualifications for the registration and marketing of foreign-manufactured medical devices in Japan

  • Manuf. Registration for Medical Device: No. 25BZ200022
  • Manuf. & Mark. License for Medical Device (Class 2):No. 25B2X10010

Namicos also holds the following professional memberships and affiliations:

  • Affiliate Member, Pharma & Biopharma Outsourcing Association (USA)
  • Member, Japan CMO (Contract Manufacturing Organization) Association
  • Supporting Member, Parental Drug Association
  • Member, Japan National Pharmaceutical Glass Ampoule Manufacturing Association
  • Member, Kansai Regional Pharmaceutical Glass Ampoule Manufacturing Association
View our Quality Policy

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