01 1CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN
02 1F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT
01 2Nitrazepam
01 1India
02 1Italy
01 2Valid
Certificate Number : CEP 2010-219 - Rev 03
Status : Valid
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 415
Certificate Number : R1-CEP 2001-286 - Rev 03
Status : Valid
Issue Date : 2014-02-24
Type : Chemical
Substance Number : 415
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.
A Nitrazepam CEP of the European Pharmacopoeia monograph is often referred to as a Nitrazepam Certificate of Suitability (COS). The purpose of a Nitrazepam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitrazepam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitrazepam to their clients by showing that a Nitrazepam CEP has been issued for it. The manufacturer submits a Nitrazepam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitrazepam CEP holder for the record. Additionally, the data presented in the Nitrazepam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitrazepam DMF.
A Nitrazepam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitrazepam CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Nitrazepam suppliers with CEP (COS) on PharmaCompass.
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