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The FY 2018 fee represents a significant drop from FY17's FDF fee of $258,646
August 28, 2017
By: Kristin Brooks
Managing Editor, Contract Pharma
The FDA has announced fiscal year 2018 rates under the Generic Drug User Fee Amendments (GDUFA) for contract manufacturing organization facilities. 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: 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 Click here for the complete announcement.
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