In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Zantac, AH 19065, Azantac, Ranitidine hydrochloride Drug Master File in Korea (Zantac, AH 19065, Azantac, Ranitidine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zantac, AH 19065, Azantac, Ranitidine hydrochloride. The MFDS reviews the Zantac, AH 19065, Azantac, Ranitidine hydrochloride KDMF as part of the drug registration process and uses the information provided in the Zantac, AH 19065, Azantac, Ranitidine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zantac, AH 19065, Azantac, Ranitidine 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 Zantac, AH 19065, Azantac, Ranitidine hydrochloride API can apply through the Korea Drug Master File (KDMF).
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