01 1F. I. S. Fabrica Italiana Sintetici S. p. A.
01 1Clonazepam
01 1Italy
Registration Number : 217MF10543
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2010-03-17
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A 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one, including repackagers and relabelers. The FDA regulates 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one supplier is an individual or a company that provides 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one active pharmaceutical ingredient (API) or 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one finished formulations upon request. The 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one suppliers may include 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one API manufacturers, exporters, distributors and traders.
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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 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one Drug Master File in Japan (7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one JDMF) empowers 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one 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 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one JDMF during the approval evaluation for pharmaceutical products. At the time of 7-Nitro-5-(2-chlorophenyl)-3H-1,4-benzodiazepin-2(1H)-one JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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