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