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About
American Regent

American Regent has a long history in the pharmaceutical community.  Since the launch of our company under the name American Quinine in 1967 to our recent product launch of the first preservative free generic Hydroxyprogesterone Caproate Injection, USP in 2018, you’ll find some highlights of our history illustrated below.

Explore our history

  1. 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.

    Mid 1980s

    Luitpold Pharmaceuticals, Inc. acquires American Quinine and transforms the name to American Regent Laboratories, Inc.
  2. 1991

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

    1996

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

  3. 2000

    Venofer® (iron sucrose injection, USP) is approved. Since its inception in the United States, Venofer® has emerged as a brand leader and is now the #1 selling IV iron in the US.**Source: IMS, NSP Audit Dollars & Units 3 year MAT ending January 2017

    2002

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

    2005

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

    2009

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

  4. 2013

    Injectafer® (ferric carboxymaltose injection) is FDA Approved. It is the first non-dextran iron.*

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

    2016

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

    2018

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

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

  • 28 Aug 2018

    American Regent Announces the Launch and Availability of Fomepizole Injection, AP Rated and Therapeutically Equivalent to Antizol®

    Shirley, NY — American Regent today announced the launch and availability of Fomepizole Injection, AP rated and therapeutically equivalent to Antizol®.

    Read more

  • St. John’s University and American Regent Post-Doctoral Pharmaceutical Industry Fellowship

    The program offers fellowships in both Medical Affairs & Pharmaceutical Marketing and in Clinical Research & Development.

    Read more

Explore Our Company

Our Values

  1. American Regent is committed to providing the ever-changing healthcare marketplace with a growing and diversified portfolio of branded and generic specialty injectable products
  2. The health of patients is our guiding principle
  3. Playing a small, but key, role in advancing healthcare solutions brings us great pride
  4. With this in mind, we want you to not only consider us your specialty injectable company, but also a partner and value-added resource for the services you require

Commercial Capabilities

Our Commercial Capabilities Allow us to Maximize a Diversified Portfolio

  1. Deep Group Purchasing Organization relationships with broad contracts to get products ON the shelf
  2. Effective use of wholesalers and distributors in alternative channels
  3. Integrated Delivery Network and hospital level relationships with Key Account Managers help get products OFF the shelf
  4. Effective engagement with physicians, pharmacists and other hospital stakeholders to drive product awareness and Generic conversion

Manufacturing Capabilities

American Regent’s manufacturing operation is made up of three facilities, situated in New York and Ohio, totaling over 100,000 square feet of manufacturing and packaging space. The operation includes traditional high-speed, high-output fill-finish facilities as well as a state-of-the-art facility that is capable of manufacturing cytotoxic compounds in both liquid and lyophilized formats.

American Regent is capable of manufacturing a broad range of batch sizes with fill volumes from 1 mL to 100 mL in vials sizes from 1 mL to 100 mL, is able to package products in glass vials and ampules, and can manufacture up to 70 million units per year.

Product Development

American Regent in an excellent position for future growth because of our capabilities in the area of pharmaceutical product development.

  1. "Turn Key" Product Development Center with capabilities to take a New Chemical Entity (NCE) or a Generic Drug from from 'lab bench to patients' bedside'
  2. Robust and diversified pipeline of injectables for future growth encompassing multiple disease indications
  3. State of the art formulation and analytical laboratories in New Albany, Ohio
  4. Development capabilities include hormones, controlled substances, cytotoxic molecules, imaging products, antibiotics, nutritional products and complex generics (peptides, microspheres, lipid based nano-carriers drug delivery systems)
  5. People with a proven track record of fast-tracking both NDAs and ANDAs with innovative regulatory strategies
  6. Current Good Manufacturing Practice: Manufacturing facilities capable of handling cytotoxic molecules and controlled substances among others (Liquid/Lyophilization/Suspensions)

Executive Team

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