01 1Dynamit Nobel GmbH, Explosivstoff- und Systemtechnik Leverkusen DE
02 1ONY, INC. Amherst US
01 1Calf Lung Surfactant Extract
02 1Glyceryl trinitrate solution
01 1Germany
02 1U.S.A
01 2Valid
Certificate Number : R1-CEP 2003-185 - Rev 01
Status : Valid
Issue Date : 2016-06-27
Type : Chemical
Substance Number : 1331
Certificate Number : R1-CEP 2008-285 - Rev 00
Status : Valid
Issue Date : 2014-05-19
Type : TSE
Substance Number :
A Nitroglycerin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitroglycerin, including repackagers and relabelers. The FDA regulates Nitroglycerin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitroglycerin 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 Nitroglycerin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitroglycerin supplier is an individual or a company that provides Nitroglycerin active pharmaceutical ingredient (API) or Nitroglycerin finished formulations upon request. The Nitroglycerin suppliers may include Nitroglycerin API manufacturers, exporters, distributors and traders.
click here to find a list of Nitroglycerin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitroglycerin CEP of the European Pharmacopoeia monograph is often referred to as a Nitroglycerin Certificate of Suitability (COS). The purpose of a Nitroglycerin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitroglycerin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitroglycerin to their clients by showing that a Nitroglycerin CEP has been issued for it. The manufacturer submits a Nitroglycerin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitroglycerin CEP holder for the record. Additionally, the data presented in the Nitroglycerin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitroglycerin DMF.
A Nitroglycerin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitroglycerin 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 Nitroglycerin suppliers with CEP (COS) on PharmaCompass.
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