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