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