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/
Entities that registered with the FDA during the Coronavirus Disease 2019 (COVID-19) pandemic, and whose sole activity with respect to OTC monograph d...
A DUNS Number is now required for all U.S. FDA Registrations: Food Facility, Food Canning Establishment, Cosmetic Establishment, Drug Establishment, M...
Unlike other companies offering FDA Registration and Compliance Services, ITB HOLDINGS LLC does not charge a separate fee for U.S. Agent. ITB HOLDINGS...
If the specified FCE (Food Canning Establishment) number or SID (Submission Identifier) is not on file, it may indicate that the establishment has not...
More Details