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Committed to US-based manufacturing

Over the last several years, we have made significant investments in expanding and modernizing our
US-based manufacturing facilities. This expansion will nearly double our capacity, and allow us to meet demand
well into the future.

Featured image is Chimney Rock State Park, Rutherford County, North Carolina in the United States.

Explore our history

  1. 2023

    American Regent acquires and then merges with HBT Labs, Inc.


    Selenious Acid Injection, USP is launched in a single-dose vial


    Multrys® (trace elements injection*, USP) is launched


    Tralement® (trace elements injection*, USP), the first FDA-approved trace elements injection is introduced

  2. 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.


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


    American Regent celebrates its 50th Anniversary

  3. 2016

    Launch of ProvayBlue® (methylene blue) Injection, 0.5%, USP*

    *ProvayBlue® is a registered trademark of Provepharm Life Solutions, France


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

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


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

  4. 2005

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


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


    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


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

  5. 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.


    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


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. 


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 US 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.



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 help mitigate shortages, or meet changes in market needs. Our short, less complicated supply chain allows us to ensure critical medications reach patients faster.   


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 schedulingensuring more rapid responses to changes in market demand.


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. May 13, 2019.  Accessed July 3, 2019.

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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

  • 26 Aug 2023

    American Regent Announces Results from Phase 3 HEART-FID Trial with INJECTAFER®

    Shirley, NY–August 26, 2023: American Regent, Inc., a Daiichi Sankyo Group company, today announced results from the phase 3 HEART-FID trial of INJECTAFER (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF).

    Read more

  • 5 Jun 2023

    INJECTAFER® Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with Heart Failure

    Basking Ridge, NJ and Shirley, NY – June 5, 2023: Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) approved INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve exercise capacity.

    Read more

Executive Team

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