A COMPARATIVE REVIEW OF USFDA AND CDSCO DRUG MASTER FILE SUBMISSION STRATEGIES FOR API MANUFACTURERS

The globalization of pharmaceutical manufacturing has significantly increased the need for transparent, efficient, and harmonized regulatory pathways for Drug Master File (DMF) submissions. Active Pharmaceutical Ingredient (API) manufacturers play a critical role in ensuring the quality, safety, and consistency of drug substances supplied to formulation companies worldwide. To safeguard public health, regulatory agencies such as the United States Food and Drug Administration (USFDA) and the Central Drugs Standard Control Organization (CDSCO), India, have established structured DMF submission frameworks that allow manufacturers to confidentially submit detailed information about API development, manufacturing, quality controls, and stability data.