Fees for Drug Services
FDA Registration and Listing
- FDA Drug Establishment Registration: $845 (Includes Certificate)
- Registrant Contact and U.S. Agent (for Non-US): $995 (Annual Fee)
- Certificate of Registration: $195
- Drug Listings: $645 per listing
Discounts available for multiple listings.
Labeling and Ingredient Review
- Labeling Review: $1,495 per product
- Label Creation: $1,995 per product
Discounts available for multiple products.
- U.S. Adverse Event Contact for OTC Labels: $500
- Registration and Registrant Contact: $1,995
Self-Identification for Generic Drug Establishments
- Self-Identification Submission: $995
No cost for Registrant Contact and U.S. Agent Clients.
Drug Master File (DMF) Submissions
- DMF Submission (CTD to eCTD): $1,995
For Non-CTD submissions, contact Registrar Corp.
- DMF Agent for FDA Communications: $995 (Annual Fee)
Color Additive Requirements
- Color Additive Report: $395 per color
- Color Batch Certification Filing: $395 per batch
Export Certificate of a Pharmaceutical Product
- Export Certificate: $195
FDA charges a $175 fee for the first certificate, $90 for the second copy, and $40 for subsequent copies of the same certificate.