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