In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Aspirin,ACETYLSALICYLIC ACID Drug Master File in Korea (Aspirin,ACETYLSALICYLIC ACID KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aspirin,ACETYLSALICYLIC ACID. The MFDS reviews the Aspirin,ACETYLSALICYLIC ACID KDMF as part of the drug registration process and uses the information provided in the Aspirin,ACETYLSALICYLIC ACID KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aspirin,ACETYLSALICYLIC ACID 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 Aspirin,ACETYLSALICYLIC ACID API can apply through the Korea Drug Master File (KDMF).
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