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