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