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