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