Launching Sterile Water for Injection, USP - First in the USA in plastic pre-filled syringe

The Medefil Story

Medefil, Inc. was incorporated in 1998 with the focus on addressing the unmet need in the saline and heparin flush injectable products.  Medefil’s commitment to providing high quality, cost-effective sterile pharmaceutical products leading us to installing two state of the art automated syringe manufacturing lines. To-date Medefil has supplied over one Billion sterile prefilled syringe products through these automated syringe lines.

After spending over 15 years gaining and establishing manufacturing excellence, a decision was made to move into formulation and development of injectable products. Medefil  has now established a state of the art R&D lab with capability of developing injectable products and are now installing additional manufacturing lines that will give us the ability to supply high quality cost effective injectable products.

Medefil’s History

Medefil Logo

February 1998

Medefil is founded.
Medefil Normal Saline I.V. Flush Syringes

February 2000

Normal Saline Flush FDA approval
Medefil Heparin I.V. Flush Syringe 10 Units/mL

June 2000

Heparin Flush FDA approval

June 2002

Fully Automated Syringe Lines
Medefil ISO 13485 Certification

February 2009

ISO Certification
Medefil Sodium Chloride Injection

January 2012

NDA Approval of Pre-filled Syringe Drug Product
Medefil Facility

January 2016

405 Windy Point Drive Facility Acquired
Medefil R&D Lab Established

November 2016

R&D Lab Established

May 2019

ANDA Approval of 10% Calcium Chloride Injection, USP
Medefil Manufacturing Expansion

June 2019

Manufacturing Expansion

December 2019

ANDA Approval of Sterile Water for Injection, USP

Our Mission

Always Innovating

We are a specialty pharmaceutical company dedicated to improving patient safety and quality of life by developing and manufacturing high-quality and affordable injectable products that fulfill a critical unmet market need.

Our Vision

Medefil strives to identify critical unmet needs in medication delivery and resolve them.

Our Business Model

Medefil is growing as a fully integrated specialty pharmaceutical company. At Medefil our goal is to develop and manufacture injectable products where quality and supply reliability are crucial, and safety and ease-of use are of utmost importance.

Medefil is committed to building a diversified pipeline that aligns with Medefil’s philosophy for success:

Critical Injectable

Injectable with shortage and supply issues

Complex Injectable

Difficulty to develop and manufacture injectable products

Product Enhancement

Enhancement of injectable product to create value at the point of care


Medefil is lead by experience management team with deep roots in the pharmaceutical industry and a track record of successful value creation.
Learn more about leadership


Explore opportunities to become part of a fast growing organization with a opportunity to significantly impact patients lives.
View open positions


We are dedicated to being a one stop shop for the state-of-the-are development and manufacturing of injectable medication.
Read about our capabilities

Reach Out

We’re eager to meet your needs and deliver solutions