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