What is Gdufa 3?

The implementation of GDUFA III aims to ensure the continued safety and efficacy of generic drugs by promoting the quality and integrity of the manufacturing processes. By charging fees to facilities that meet these criteria, the program helps to fund the necessary inspections and evaluations conducted by regulatory agencies.

GDUFA III introduces a revised fee structure for facility owners in the pharmaceutical industry. This framework requires facilities to pay a fee if certain conditions are met on the due date of the facility fee.

One of the conditions that must be fulfilled is that the facility must be referenced in an approved generic drug submission. This means that the facility is involved in the production or processing of a generic drug that has been approved by the relevant regulatory authorities.

Additionally, the facility must also be engaged in the manufacturing or processing of an Active Pharmaceutical Ingredient (API) or Finished Dosage Form (FDF). This covers a wide range of activities, from the synthesis of APIs to the formulation and packaging of FDFs.

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