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