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