ANDA Post-approval Changes - Overview
ANDA post-approval changes are important throughout the lifecycle of a generic drug product. After the approval of a generic drug application and during the commercialization of the drug product, manufacturers may propose certain changes to an ANDA/DMF to optimize the operational cost, increase productivity, or due to administrative reasons. These post-approval changes are submitted to the US FDA by filing supplements or amendments per 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 categorized as major, moderate, and minor, and the types of submissions and the necessity for prior approval from the US FDA before the change implementation are varied.
Timely submission of the respective supplement/amendment/annual report is critical to maintain the lifecycle of the product and be compliant. In case of an inappropriate categorization of the change, preparation of a post-approval submission strategy is crucial to avoid rejections from the US FDA.
Freyr’s Regulatory affairs team has extensive knowledge and experience in handling US FDA post-approval changes to ANDA and DMF, with their submissions aligned to the requirements and guidelines of the US FDA.
ANDA Post-approval Changes - Expertise
- Change/addition/deletion in the manufacturing site.
- ANDA/DMF holder transfers.
- Optimization of manufacturing process/change in route of synthesis/change in equipment.
- Change in formulation/batch size.
- Addition of new supplier for active substance/CEP updates/new CEP.
- Inclusion of additional sources for the starting material of the drug substance.
- Monograph updates, i.e., CMC Regulatory compliance to the US Pharmacopoeia.
- Specifications and analytical method changes.
- Changes in container closure systems and suppliers.
- Shelf-life extension/reduction.
- Administrative updates/contact details changes.
- CMC Regulatory Compliance.
