Explore our history
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2020-Present
2023
American Regent acquires and then merges with HBT Labs, Inc.
2022
Selenious Acid Injection, USP is launched in a single-dose vial
2021
Multrys® (trace elements injection*, USP) is launched
2020
Tralement® (trace elements injection*, USP), the first FDA-approved trace elements injection is introduced
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2017-2019
July 2019
Launch of the first and only
FDA-approved Selenious Acid Injection, USPJanuary 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, USP2017
American Regent celebrates its 50th Anniversary
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2006-2016
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.
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1996-2005
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 20171996
American Regent Laboratories introduces Dexferrum® (iron dextran injection, USP).
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1960s-1995
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 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.
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 help 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 …
The Latest
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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).
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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.
