Typical Fda Comments on Impurity Profiling in Ctd/cep/dmf Submissions
نویسنده
چکیده
Impurity profiling is a highly intelligent, tedious and expensive task in standardizing the drug products for marketing Authorization. This task usually more complex when the proper impurity standards are not available and synthesis of the same require extra ordinary high cost and time. It has been observed that many a time application for ANDA/DMF/CEP is delayed due to extra ordinary delay in compiling impurity profiling. Further, the approval of many of drug product is denied for inadequate impurity profiling.
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