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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
- Jubilant HollisterStier LLC
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Avenue
Building 71 Room 3103Silver Spring, MD 20993-0002