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