In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Benzene-1,4-diol Drug Master File in Korea (Benzene-1,4-diol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benzene-1,4-diol. The MFDS reviews the Benzene-1,4-diol KDMF as part of the drug registration process and uses the information provided in the Benzene-1,4-diol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benzene-1,4-diol 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 Benzene-1,4-diol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benzene-1,4-diol suppliers with KDMF on PharmaCompass.