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