Do Excipients Need FDA Approval? What Pharmaceutical Manufacturers Need to Know

In pharmaceutical manufacturing, active pharmaceutical ingredients (APIs) often get the spotlight, but excipients play a vital role in drug formulation. Whether you are developing a tablet, capsule, injectable, or inhalable product, excipients influence everything from stability and solubility to bioavailability and dosing accuracy. One common question we hear is:Do excipients need FDA approval? The short […]

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