In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Protox 169 Drug Master File in Korea (Protox 169 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Protox 169. The MFDS reviews the Protox 169 KDMF as part of the drug registration process and uses the information provided in the Protox 169 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Protox 169 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 Protox 169 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Protox 169 suppliers with KDMF on PharmaCompass.