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