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