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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The FY 25 fee show a steep hike of ANDA fee to ₹ 3,21,920 from $ 252,453 for FY 24, an increase of 27.5%. The new fee are effective on October 1, 2024, and will remain in effect through September 30, 2025. There is hike in fee for other categories as well ranging from 5-10%. However the DMF fee has seen only marginal increase to ₹ 95,084 from $ 94,682.
The new Foreign API facility fee is $56,580 (up 2%) and FDF facility fee is $2,46,952 (up 4.9%). Various GDYFA III are tabulated as below with comparative figures for FY 24 and FY 23.
| GDUFA III Fee Schedule for FY 2025 | ||||
| User Fee Type | FY 23 | FY 24 | FY 25 | |
| ANDA | $ 240,582 | $ 252,453 | $3,21,920 | |
| DMF | $ 78,293 | $ 94,682 | $95,084 | |
| Program | Large Size | $ 1,620,556 | $ 1,729,629 | $18,91,664 |
| Medium Size | $ 648,222 | $ 691,852 | $7,56,666 | |
| Small Size | $ 162,056 | $ 172,963 | $1,89,166 | |
| Facility | Domestic API | $ 37,544 | $ 40,464 | $41,580 |
| Foreign API | $ 52,544 | $ 55,464 | $56,580 | |
| Domestic FDF | $ 213,134 | $ 220,427 | $2,31,952 | |
| Foreign FDF | $ 228,134 | $ 235,427 | $2,46,952 | |
| Domestic CMO | $ 51,152 | $ 52,902 | $55,568 | |
| Foreign CMO | $ 66,152 | $ 67,902 | $70,668 | |
Generic Drug User Fee Rates for Fiscal Year 2025
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