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