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