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