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