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