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