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