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