To increase supply, FDA issued special guidelines for chloroquine drugs
In anticipation of increasing market demand for chloroquine phosphate and hydroxychloroquine sulfate, the US Food and Drug Administration (FDA) issued product-specific guidelines for such drugs to support the development of generic drugs and ensure adequate supply.
The FDA's product-specific guidelines for chloroquine phosphate indicate that the drug is rated AA in its "Orange Book"-Approved Drug Products with Therapeutic Equivalence Evaluations, so there are no known or possible bioequivalence issues, and there is no need to Carry out in vivo tests.
At the same time, the product-specific guidelines for hydroxychloroquine sulfate suggest that a bioequivalence exemption can be implemented for the drug based on the Biopharmaceutics Classification System.
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2026-08-05
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