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