01 1Pharma Mar, S. A.
01 1Trabectedin
01 1Spain
Registration Number : 226MF10132
Registrant's Address : Avenida de los Reyes 1, P. I. La Mina 28770 Colmenar Viejo, Madrid, Spain
Initial Date of Registration : 2014-07-02
Latest Date of Registration : 2024-11-27
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Trabectedin Drug Master File in Japan (Trabectedin JDMF) empowers Trabectedin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Trabectedin JDMF during the approval evaluation for pharmaceutical products. At the time of Trabectedin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Trabectedin suppliers with JDMF on PharmaCompass.
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