01 1Cambrex Profarmaco Milano S. r. l.
01 1Clorazepate dipotassium
01 1U.S.A
Registration Number : 219MF10063
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2019-08-29
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A Tranxilium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tranxilium, including repackagers and relabelers. The FDA regulates Tranxilium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tranxilium 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 Tranxilium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tranxilium supplier is an individual or a company that provides Tranxilium active pharmaceutical ingredient (API) or Tranxilium finished formulations upon request. The Tranxilium suppliers may include Tranxilium API manufacturers, exporters, distributors and traders.
click here to find a list of Tranxilium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Tranxilium Drug Master File in Japan (Tranxilium JDMF) empowers Tranxilium 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 Tranxilium JDMF during the approval evaluation for pharmaceutical products. At the time of Tranxilium 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 Tranxilium suppliers with JDMF on PharmaCompass.
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