Explore our history
Launch of the first and only
FDA-approved Selenious Acid Injection, USP
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
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.
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).
Sankyo, a Japanese pharmaceutical company, acquires Luitpold and its subsidiary, American Regent Laboratories, Inc.
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
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.
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 scheduling—ensuring 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. https://www.fda.gov/media/125000/download. May 13, 2019. Accessed July 3, 2019.
American Regent is a leading manufacturer of generic and branded specialty injectables. Given the dynamics of today’s challenging healthcare marketplace …
6 May 2021
Injectafer® (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia
Basking Ridge, N.J. and Shirley, N.Y. (May 6, 2021): Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a single 1000 mg dose option of Injectafer® (ferric carboxymaltose injection), an iron replacement product, for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron, have had unsatisfactory response to oral iron, or have non-dialysis dependent chronic kidney disease (CKD).1
1 Apr 2021
American Regent, Inc. Announces New CEO
Shirley, NY – April 1, 2021: Paul Diolosa assumed the role of President and CEO of American Regent, Inc., a Daiichi Sankyo Group company, effective today.