On September 5th, the U.S. Food and Drug Administration announced a “Green List” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.
According to the FDA announcement, “the green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards – standards applicable to all APIs manufactured in the U.S. APIs from other sources are subject to detention without physical examination.”
Read the full “Green List” Import Alert HERE.
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Please feel free to reach out to any member of the Pharma Source Team with any questions you may have about the recent FDA guidance or any other regulatory questions you may have. Contact Us >