The fiscal 2013 fees are as follows:
- U.S. finished dosage form (FDF) facilities - $175,389;
- Non-U.S. FDF facilities - $190,389;
- U.S. active pharmaceutical ingredient (API) manufacturing facilities - $26,458; and
- Non-U.S. API facilities - $41,458.
The FDF fees are higher than originally anticipated, due to the lower-than-expected amount of facilities that self-identified and will now share the costs. The FDA previously predicted the fee for API facilities would be roughly $35,000 and the fee for FDF facilities would be roughly $150,000.
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