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