In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ACETYLSALICYLIC ACID, ASPIRIN Drug Master File in Korea (ACETYLSALICYLIC ACID, ASPIRIN KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ACETYLSALICYLIC ACID, ASPIRIN. The MFDS reviews the ACETYLSALICYLIC ACID, ASPIRIN KDMF as part of the drug registration process and uses the information provided in the ACETYLSALICYLIC ACID, ASPIRIN KDMF to evaluate the safety and efficacy of the drug.
After submitting a ACETYLSALICYLIC ACID, ASPIRIN KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their ACETYLSALICYLIC ACID, ASPIRIN API can apply through the Korea Drug Master File (KDMF).
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