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