04/04/2023 Other Services
On March 24, 2023, FDA announced the rates for over-the-counter (OTC) monograph drug user fees (OMUFA) for fiscal year (FY) 2023.
Facility fee rates increased 8 percent in comparison to the FY 2022.
Monograph Drug Facility (MDF) Facility Fee: $26,153
Contract Manufacturing Organization (CMO) Facility Fee: $17,435
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
https://www.itbhdg.com/otc-drugs/
On March 24, 2023, FDA announced the rates for over-the-counter (OTC) monograph drug user fees (OMUFA) for fiscal year (FY) 2023. Facility fee rates i...
FDA OTC DRUG FACILITY REGISTRATION LIMITED OFFER includes * Company Registration * Product Listing * U.S. Agent Service Domestic and foreign companies...
For FY 2023, the United States FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facil...
An OTC monograph drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manu...
More Details