The journey of a pharmaceutical product from discovery to market is a complex and highly regulated process. For generic drug manufacturers, successfully filing an Abbreviated New Drug Application (ANDA) with regulatory bodies like the FDA is a critical milestone. This process requires comprehensive data demonstrating that the generic product is bioequivalent to the reference listed drug and meets all quality standards. Alpha-Hydroxy Flurbiprofen, identified by CAS number 61466-95-3, plays a significant, albeit specific, role in facilitating this crucial step, particularly within the context of ANDA filing support.

As a well-characterized impurity or intermediate related to Flurbiprofen, Alpha-Hydroxy Flurbiprofen is instrumental in demonstrating a thorough understanding of the drug's chemical composition and potential impurities. Regulatory agencies demand rigorous documentation of impurity profiles. By using Alpha-Hydroxy Flurbiprofen as a reference standard in analytical methods, pharmaceutical companies can accurately quantify and control these impurities in their manufacturing processes. This not only satisfies regulatory requirements but also contributes to the overall safety profile of the drug, which is a key component in drug formulation toxicity study.

The importance of reliable chemical intermediates extends to the broader spectrum of drug development processes. Whether a company is developing a new chemical entity or a generic version of an existing drug, having access to high-quality building blocks like Alpha-Hydroxy Flurbiprofen is essential. NINGBO INNO PHARMCHEM CO.,LTD., with its robust capabilities in custom synthesis of pharmaceutical intermediates, provides the necessary materials to support these diverse development needs. Their ability to supply materials with consistent purity and detailed analytical data assures clients that they have a reliable partner in their research and manufacturing endeavors.

Ultimately, the availability of intermediates like Alpha-Hydroxy Flurbiprofen from reputable suppliers such as NINGBO INNO PHARMCHEM CO.,LTD. underpins the integrity of the pharmaceutical supply chain. It enables companies to conduct thorough flurbiprofen impurity profiling, optimize manufacturing processes, and confidently submit applications for market approval, thereby contributing to greater access to essential medications for patients worldwide.