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