In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ethyl 4-aminobenzoate Drug Master File in Korea (Ethyl 4-aminobenzoate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ethyl 4-aminobenzoate. The MFDS reviews the Ethyl 4-aminobenzoate KDMF as part of the drug registration process and uses the information provided in the Ethyl 4-aminobenzoate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ethyl 4-aminobenzoate 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 Ethyl 4-aminobenzoate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ethyl 4-aminobenzoate suppliers with KDMF on PharmaCompass.