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
A Clorazepate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clorazepate, including repackagers and relabelers. The FDA regulates Clorazepate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clorazepate 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 Clorazepate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clorazepate supplier is an individual or a company that provides Clorazepate active pharmaceutical ingredient (API) or Clorazepate finished formulations upon request. The Clorazepate suppliers may include Clorazepate API manufacturers, exporters, distributors and traders.
click here to find a list of Clorazepate 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 Clorazepate Drug Master File in Japan (Clorazepate JDMF) empowers Clorazepate 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 Clorazepate JDMF during the approval evaluation for pharmaceutical products. At the time of Clorazepate 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 Clorazepate suppliers with JDMF on PharmaCompass.
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