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