GDUFA & SELF-IDENTIFICATION
API/Drug Product Facilities Contract Re-packager/Testing Lab BA/BE Sites

GENERIC DRUG USER FEE ACT (GDUFA) & SELF-IDENTIFICATION SPL SUBMISSION

Beginning in fiscal year 2013, the U.S.FDA will assess and collect facilities fees in accordance with generic drug user fee act (GDUFA) program. These include facilities manufacturing, or intending to manufacture, active pharmaceutical ingredient (API) of human generic drugs and/or finished dosage form (FDF) human generic drugs. Other sites and organizations must self- identify, but will not be required to pay the annual facility user fee.

Following types of generic industry facilities, sites, and organizations are required to self- identify with U.S.FDA:

  • Human generic drug APIs or Drug Product or both.
  • Sites and organizations that package the human generic drug product into the primary container/closure system and label the primary container/closure system.
  • Contract re-packager of human generic drug product.
  • Bioequivalence (BE)/bioavailability (BA) sites.
  • API/Drug product contract testing laboratory.

Docent Pharma offers following services to help human generic drug facilities, sites, and organizations prepare to meet the GDUFA self-identification requirement.

  • Guidance & Procurement for Data Universal Numbering System (DUNS) numbers.
  • Creating the Self-Identification Submission in SPL Format
  • Electronic Submissions Gateway (ESG) Submission.
  • Consultancy on Generic Drug User Fee Act (GDUFA)