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Injectable Allergen Extracts- Non-Standardized

Injectable Allergen Extracts

Allergen extracts are currently manufactured in two forms: standardized and non-standardized. For the standardized allergen extracts, manufacturers compare the allergen extract to a U.S. reference standard for potency. CBER maintains these reference standards and distributes them to manufacturers. There are currently 19 standardized allergenic extracts.

Extracts for which there are no U.S. reference standards are called non-standardized extracts.

Non-Standardized Allergen Extracts Licensed for Distribution in the United States

Each manufacturer listed below holds a U.S. license to manufacture and distribute certain non-standardized allergen extracts.

Information Updated DATE

  • ALK Abello
  • Allergy Laboratories
  • Allermed Laboratories
  • Antigen Laboratories
  • Greer
  • Jubilant HollisterStier LLC

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 04/03/2014
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