| Title: | FDA Entry information for finished dosage drug products |
|---|---|
| Date: | 2014-07-11 |
| To: | abi |
| Links: | previous, original, next |
FROM: US FOOD AND DRUG ADMINISTRATION
As part of the normal import screening process for finished dosage drug products, FDA does verify the status of the API manufacturer. While this verification is part of the normal entry review process performed by FDA, brokers are not required to provide the API manufacturer when filing entry for a finished dosage drug product. However, there may be instances when brokers are requested to verify the source of the API used to manufacture the finish dosage product being offered for entry.
If there are any questions please contact FDA's Division of Import Operations at 301-796-0356