When applying for the listing of generic drugs and the consistency evaluation of the quality and efficacy of generic drugs, under the premise that the production scale of the registered batches meets the requirements, the filing information needs to include at least three registered batch samples of six-month long-term stability test data. Therefore, stability studies play a crucial role in the pharmaceutical industry, especially in the development and evaluation of generic drugs. These studies assess the stability and shelf-life of generic drugs under various conditions, ensuring their quality, efficacy, and safety throughout their intended storage period.
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Focusing on drug quality research and management for many years, Alfa Chemistry provides you with reliable generic stability evaluation services in accordance with FDA guidelines.