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