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Quality of API Supplier Can Lead to Refuse-to-Receive Decision

One year after the implementation of GDUFA, the FDA has met their timeline by providing guidance on enhanced Refusal-to-Receive standards for ANDAs and related submissions. The Guidance for Industry ANDA Submissions – Refuse-to Receive Standards, published October 2013, provides clarification on the Refuse-to-Receive criteria which will improve the quality of ANDA submissions ultimately leading to faster FDA approval time. Full implementation is expected June 20, 2014.

The guidance identifies the types of deficiencies that would prompt a Refuse-to-Receive decision in addition to defining major vs. minor deficiencies, steps to resolve deficiencies and the consequences for each type of deficiency. The areas that deficiencies can occur fall into the following six categories:

  1. Missing Application Form FDA 356h
  2. Organization and Format of ANDA Submission
  3. GDUFA Fee Obligations
  4. Labeling
  5. Type II DMF and API Review
  6. Chemistry, Manufacturing and Control

Type II API DMF Review Deficiencies
How will the quality of your API supplier affect your company’s ability to maintain a fast to market advantage? The FDA’s Refuse-to-Receive guidance specifically identifies the following deficiencies as it relates to API suppliers and manufacturers.

  • ANDA references a Type II API DMF not on Available for Reference list because of non-payment of the GDUFA DMF fee.
  • ANDA references a Type II API DMF submitted to FDA after the ANDA submission date.
  • ANDA references a Type II API DMF that has not received Available for Reference status from the FDA prior to the ANDA review date.**
  • ANDA references a Type II API DMF that initial Completeness Assessment is given “Incomplete” status.
  • ANDA references a manufacturer on the Facility Arrears List for failure to pay the GDUFA facility fee.

** As an added measure, the FDA is recommending Type II API DMFs should be submitted AT LEAST 6 months in advance of an ANDA submission.

The bottom line is, your API supplier matters now more than ever; choosing a company that has a commitment to regulatory compliance, product excellence, an understanding of the constantly changing regulatory guidelines and the financial stability to follow through on GDUFA fee commitments.

Our ‘One World-One Quality’ approach is the back bone of everything we do, every decision we make; making ChemWerth the ‘One Company’ for your API needs.