Medefil was incorporated in 1998 to establish State of the Art Manufacturing facilities with a vision to create a center of excellence for sterile pharmaceutical injectable products.
- 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 & ISO 13485 Certification, Recertification in 2011, 2014
- 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 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 – Additional 100,000 Sq. Ft. facility for Aseptic, Terminally Sterilized, and Lyophilized Products.
- Expansion of laboratory space to along with the additional state of the art capabilities for the analytical Chemistry, Microbiology and meteorology labs.
Compliance and Quality Statement
Medefil operates a FDA registered and ISO certified, fully automated, drug and device manufacturing facility. We have a commitment to produce products that are safe, efficacious, and of the highest quality. We place quality first because we care and are concerned for the safety of the end user of our products in hospitals and clinics. We have state-of-the-art processes for manufacturing the prefilled syringes