Launching Atropine Sulfate Injection, USP, 1 mg/10 mL (0.1 mg/mL), in plastic pre-filled syringe

The Medefil Story

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

After spending over 15 years establishing manufacturing excellence, Medefil made the decision to begin formulation and development of injectable products. Medefil, now has a state-of-the-art R&D lab with the capability of developing injectable products and is 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 510(k) Clearance
Medefil Heparin I.V. Flush Syringe 10 units/mL

June 2000

Heparin Lock Flush FDA 510(k) Clearance

June 2002

Fully Automated Syringe Lines

February 2009

ISO Certification
Medefil Sodium Chloride Injection

January 2012

NDA-Sod. Chl. Inj., USP, 0.9%-Dilute & Dissolve
Medefil Facility

January 2016

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

November 2016

R&D Lab Established

May 2019

ANDA-10% Calcium Chloride Injection, USP
Medefil Manufacturing Expansion

June 2019

Manufacturing Expansion

December 2019

ANDA-Sterile Water for Injection, USP

November 2022

ANDA-Atropine Sulfate 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.
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Explore opportunities to become part of a fast growing organization with a opportunity to significantly impact patients lives.
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We are dedicated to being a one stop shop for the state-of-the-are development and manufacturing of injectable medication.
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