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