Milestones

  • February, 1998: Medefil, Inc. is Incorporated
  • February, 2000: US FDA 510(k) - Normal Saline I. V. Flush Syringe (Semi Automatic Process)
  • June, 2000: US FDA 510(k) - Heparin I. V. Flush Syringe, 10 and 100 Units / mL (Semi Automatic Process)
  • June, 2002: US FDA 510(k) - Normal Saline I. V. Flush Syringe and Heparin I. V. Flush Syringe, (Fully Automatic Process)
  • February, 2008: ISO 9001 Certification, Recertification in 2011, 2014
  • February, 2008: ISO 13485 Certification, Recertification in 2011, 2014, 2017
  • April, 2008: Health Canada Approval - Pre-Filled Syringes
  • December, 2009: CE Approval to Market in EU, Recertification in 2011
  • January / February, 2010: US FDA 510(k) - Terminally Sterilized Product in Pre-Filled Syringes
  • April, 2011: Transition to Fully Automated, Terminal Sterilized Pre-Filled Syringes from Filling to Final Cartoning without any human intervention
  • January, 2012: US FDA 505(b)(2) [NDA] Approval � Drug Product in Pre-Filled Syringe
  • March, 2012: Health Canada Approval Anticoagulant Sodium Citrate, 4%, USP in a Pre-Filled Syringe
  • January, 2013: Initiated Drug Development for Generic Injectable (Vials, Syringes, & Lyophilized) Products
  • March, 2014: Submission of Anticoagulant Drug Product in Vial to the US FDA
  • 2015: Expansion of facility (Under Construction) - Additional 100,000 Sq. Ft. facility for Aseptic, Terminally Sterilized, and Lyophilized Products.
  • 2015: Expansion of laboratory (Under Construction) - Additional state-of-the-art capabilities for the analytical Chemistry, Microbiology and meteorology labs.