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