In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a SLO 369 Drug Master File in Korea (SLO 369 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SLO 369. The MFDS reviews the SLO 369 KDMF as part of the drug registration process and uses the information provided in the SLO 369 KDMF to evaluate the safety and efficacy of the drug.
After submitting a SLO 369 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 SLO 369 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SLO 369 suppliers with KDMF on PharmaCompass.