01 1Pharma Mar SA
01 1Berto Korea Limited
01 1Trabectedin
01 1Spain
Registrant Name : Berto Korea Limited
Registration Date : 2009-03-31
Registration Number : Su217-6-ND
Manufacturer Name : Pharma Mar SA
Manufacturer Address : Avda. de los Reyes 1, Pol. Ind. La Mina, 28770-Colmenar Viejo, Madrid
A Trabectedin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trabectedin, including repackagers and relabelers. The FDA regulates Trabectedin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trabectedin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Trabectedin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trabectedin supplier is an individual or a company that provides Trabectedin active pharmaceutical ingredient (API) or Trabectedin finished formulations upon request. The Trabectedin suppliers may include Trabectedin API manufacturers, exporters, distributors and traders.
click here to find a list of Trabectedin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Trabectedin Drug Master File in Korea (Trabectedin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trabectedin. The MFDS reviews the Trabectedin KDMF as part of the drug registration process and uses the information provided in the Trabectedin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trabectedin 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 Trabectedin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trabectedin suppliers with KDMF on PharmaCompass.
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