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