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We're proud to be an American manufacturer

Over 99% of the drugs available from American Regent are manufactured in America.* Because our manufacturing facilities are US-based and the majority of our active pharmaceutical ingredients and product components are sourced from the US, we are able to quickly mobilize and respond to market shortages with the quality products your patients need. 

Featured image is Chimney Rock State Park, Rutherford County, North Carolina in the United States.
*More than 99% of units manufactured in 2018 were manufactured in America with remaining unit volume coming from Canada and France.

Explore our history

  1. July 2019

    Launch of the first and only 
    FDA Approved Selenious Acid Injection, USP 

    January 2019

    American Regent, Inc. merges into Luitpold Pharmaceuticals, Inc.  The company name is changed to American Regent.

    2018

    FDA Approval and launch
    of the first preservative free generic
    Hydroxyprogesterone Caproate Injection, USP

    2017

    American Regent celebrates its 50th Anniversary

  2. 2016

    Launch of ProvayBlue® (methylene blue) Injection, 0.5%, USP*ProvayBlue® is a registered trademark of Provepharm Life Solutions, France

    2013

    Injectafer® (ferric carboxymaltose injection)* is FDA Approved. 

    Injectafer® is a registered trademark of Vifor (International) Inc., Switzerland

    2009

    Luitpold acquires PharmaForce, Inc. broadening its line of generic, multisource injectables.

  3. 2005

    Sankyo merges with
    Daiichi Pharmaceutical Company, Ltd.
    to become Daiichi-Sankyo Company, Ltd.

    2002

    The name American Regent Laboratories, Inc. was shortened to
    American Regent, Inc.

    2000

    Venofer® (iron sucrose injection, USP) now the #1 selling IV iron in the US,* is approved.
    *Source: IMS, NSP Audit Dollars & Units 3 year MAT ending January 2017

    1996

    American Regent Laboratories introduces Dexferrum® (iron dextran injection, USP).

  4. 1991

    Sankyo, a Japanese pharmaceutical company, acquires Luitpold and its subsidiary, American Regent Laboratories, Inc.

    Mid 1980s

    Luitpold Pharmaceuticals, Inc.
    acquires American Quinine and transforms the name to
    American Regent Laboratories, Inc.

    1967

    A group of dedicated professionals launch our company under the name American Quinine, which provides quality, parenteral products to medical communities within the US and Canada.

Focused on developing excellence in four strategic areas—Reliability, Speed, Flexibility and Quality

WHO WE ARE

American Regent is a top-10 injectable manufacturer with sales of over $1 Billion.  Our growing business is comprised of generic and branded injectables as well as leading branded IV iron therapies.  We hold the leading position for the majority of the products in our portfolio.

For over 50 years, we've set a higher standard for responsiveness and reliability as a US-based manufacturing company with a short supply chain.  Every day we are applying our innovative thinking to respond to customer needs by developing and delivering complex, hard-to-manufacture injectables and drug shortage products. 

RELIABILITY

Our acquisition of Pharmaforce, Inc ten years ago, was the first step toward ensuring a consistent, reliable supply of products. Today, between all three of our U.S. manufacturing sites, we have the capability to manufacture over 70 million units annually.

Over the next three to five years, we are investing $200 million in the expansion and modernization of our US based manufacturing facilities. These enhancements will allow us to significantly increase output while creating redundancies across our three manufacturing sites.  This will ensure that we continue to deliver high value for our customers by providing a more reliable, uninterrupted supply of products.

 

SPEED

Developing excellence in speed is a critical focus for American Regent because we believe patients should never have to wait for the medications they need. 

Since we are a US-based manufacturer, we are uniquely positioned to mobilize resources or change production scheduling so that we can quickly respond to mitigate shortages or meet changes in market needs. Our short, less complicated supply chain allows us to ensure critical medications reach patients faster.   

FLEXIBILITY

Just like speed, the ability to be flexible is critical in the generic injectables market. With demand being so variable, the long lead time of an offshore supply chain makes reacting quickly much more difficult, if not impossible.

American Regent, with its US-based manufacturing and short delivery timelines has greater flexibility in production scheduling ensuring more rapid responses to changes in market demand.

QUALITY

According to the FDA, US manufacturing sites scored statistically higher in terms of quality than sites located in the rest of the world.1 We’re not surprised by that fact because our robust quality organization and systems meet the highest quality standards.

Our organization focuses on prevention rather than remediation.  We are investing in highly automated manufacturing lines that limit or eliminate human interaction in our sterile filling areas. Finally, our manufacturing facilities are operated by highly trained US labor using systems that have evolved and been perfected over the last 50 years.

1-Report on the State of Pharmaceutical Quality. https://www.fda.gov/media/125000/download. May 13, 2019.  Accessed July 3, 2019.

Partner with 
American Regent

American Regent is a leading manufacturer of generic and branded specialty injectables. Given the dynamics of today’s challenging healthcare marketplace …

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The Latest

  • American Regent Announces the Launch and Availability of Selenious Acid Injection, USP­

    Shirley, NY - American Regent today announced the introduction of Selenious Acid Injection, USP.

    Read more

  • 28 Feb 2019

    American Regent Re-Introduces Aminocaproic Acid Injection, USP; AP Rated and Therapeutically Equivalent to Amicar®

    Shirley, NY - American Regent today announced the re-introduction of Aminocaproic Acid Injection, USP.

    Read more

Executive Team

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