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