The CMO finished dosage form (FDF) facility fee for FY18 is $70,362 for a U.S. site, and $85,362 for a non-U.S. site. According to PBOA president Gil Roth, this fee is a significant drop from FY17's FDF fee of $258,646. The non-CMO FDF fee is $211,087 for a U.S. site and $226,087 for a non-U.S. site. According to Mr. Roth, if the PBOA was not at the negotiating table and the GDUFA I fee formula was applied to GDUFA II's fee base of $493,600,000, the FDF fee would have been in excess of $440,000 per facility.
Under GDUFA II, CMO sites are defined as facilities that are not referenced in an approved ANDA held by the owner of that facility or its affiliates. If the parent company owns an approved ANDA and it references the CMO site, that site is not eligible for the reduced fee.
The following includes the GDUFA II fee breakdown beginning October 1:
FDF facility fee, US, non-CMO: $211,087
FDF facility fee, ex-US, non-CMO: $226,087
FDF facility fee, US, CMO: $70,362
FDF facility fee, ex-US, CMO: $85,362
API facility fee, US: $45,367
API facility fee, ex-US: $60,367
ANDA Holder fee, 1-5 approved ANDAs: $159,079
ANDA Holder fee, 6-19 approved ANDAs: $636,317
ANDA Holder fee, 1-5 approved ANDAs: $1,590,792
ANDA filing fee: $171,823
DMF filing fee: $47,829
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