01 1F. I. S. Fabrica Italiana Sintetici S. p. A.
01 1Nitrazepam
01 1Italy
Registration Number : 217MF10544
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2018-07-03
A Nitrazepam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrazepam, including repackagers and relabelers. The FDA regulates Nitrazepam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrazepam 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 Nitrazepam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrazepam supplier is an individual or a company that provides Nitrazepam active pharmaceutical ingredient (API) or Nitrazepam finished formulations upon request. The Nitrazepam suppliers may include Nitrazepam API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrazepam 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 Nitrazepam Drug Master File in Japan (Nitrazepam JDMF) empowers Nitrazepam 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 Nitrazepam JDMF during the approval evaluation for pharmaceutical products. At the time of Nitrazepam 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 Nitrazepam suppliers with JDMF on PharmaCompass.
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