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