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