FDA Anounces GDUFA Rates for fiscal year 2018

The FDA has released the Generic Drug User Fee Amendments (GDUFA) rates for contract manufacturing organization facilities of fiscal year 2018.

GDUFA is Generic Drug User Fee Amendments of FDA.
 
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.

Below includes the GDUFA II fee breakdown beginning October 1:

Recurring Fees

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
 
One-Time Fees

ANDA filing fee: $171,823

DMF filing fee: $47,829