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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.

Adverse Events

  • U.S. Adverse Event Contact for OTC Labels: $500

Outsourcing Facilities

  • 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.