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