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Product-Specific Guidances for Generic Drug Development
To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD)
Dissolution Methods- FDA
The FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Biopharmaceutics, Office of Pharmaceutical Quality
SRS data base- USFDA
FDA's Global Substance Registration System Home of the Unique Ingredient Identifier (UNII)
Inactive Ingredient Search for Approved Drug Products
The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products
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