Post-approval Changes


Post-approval activities of ANDA are equally important throughout the lifecycle of a generic drug product. After the approval of generic drug application and during the commercialization of the drug product, manufacturers may propose certain changes to an approved ANDA/DMF to optimize the operational cost, or increase productivity, or due to administrative reasons. These post-approval changes are submitted to the USFDA by filing supplements or amendments in accordance with the section 506A of the Federal Food, Drug, and Cosmetic Act and § 314.70 (21 CFR 314.70).

Based on the impact and complexity, changes to an approved ANDA have been categorised as major, moderate, and minor, and the types of submissions, as well as the necessity for prior approval from the USFDA before the implementation of the change are varied.

Timely submission of the respective supplement/amendment/annual report is critical to maintain the lifecycle of the product and to be Regulatory complaint. In case of an inappropriate categorization of the change, preparation of post-approval submission strategy is crucial to avoid rejections from the USFDA.

Freyr’s Regulatory affairs team has extensive knowledge and experience in handling post-approval changes to ANDA and DMF with their submissions to the USFDA in alignment with the requirements and guidelines.

Freyr Expertise

Freyr’s team has experience and expertise in handling the following post-approval changes with submissions to the USFDA.

  • 01

    Change/addition/deletion in the manufacturing site.

  • 02

    ANDA/DMF holder transfers

  • 03

    Optimization of manufacturing process/change in route of synthesis/change in equipment.

  • 04

    Change in formulation/batch size change.

  • 05

    Addition of new supplier for active substance/CEP updates/new CEP.

  • 06

    Inclusion of additional source for starting material for drug substance.

  • 07

    Monograph updates i.e. CMC Regulatory compliance to the US Pharmacopoeia.

  • 08

    Specifications and analytical method changes.

  • 09

    Changes in container closure system and suppliers.

  • 10

    Shelf-life extension/reduction.

  • 11

    Administrative updates/contact details changes.

  • 12

    CMC Regulatory compliance.

Freyr offers the following services to the medicinal products manufacturers:

  • 01

    Change controls/proposed changes evaluation

  • 02

    Provide consulting on submission strategy for proposed changes

  • 03

    Implementation strategy and timelines

  • 04

    Guidance on supporting documents/data

  • 05

    Preparation of supplement/amendment/annual reports

  • 06

    Interaction and follow-ups with Health Authorities for approval and implementation

  • 07

    CMC Regulatory compliance of legacy dossiers/submissions with post-approval supplements

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