In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nicosan 3 Drug Master File in Korea (Nicosan 3 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nicosan 3. The MFDS reviews the Nicosan 3 KDMF as part of the drug registration process and uses the information provided in the Nicosan 3 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nicosan 3 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 Nicosan 3 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nicosan 3 suppliers with KDMF on PharmaCompass.