01 3Lonza AG Basel CH
01 1Nicotinic Acid
02 1Nicotinic Acid, Material number 51339
03 1Nicotinic Acid, Product code 51 337
01 3Switzerland
01 1Expired
02 2Valid
Nicotinic Acid, Material Number 51339
Certificate Number : R1-CEP 2007-268 - Rev 00
Status : Valid
Issue Date : 2014-02-25
Type : Chemical
Substance Number : 459
Nicotinic Acid, Product Code 51 337
Certificate Number : R1-CEP 2006-215 - Rev 00
Status : Valid
Issue Date : 2012-10-08
Type : Chemical
Substance Number : 459
Certificate Number : R0-CEP 2000-154 - Rev 01
Status : Expired
Issue Date : 2004-11-19
Type : Chemical
Substance Number : 459
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PharmaCompass offers a list of Niacin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Niacin manufacturer or Niacin supplier for your needs.
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A [5, 6-3H]-niacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of [5, 6-3H]-niacin, including repackagers and relabelers. The FDA regulates [5, 6-3H]-niacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. [5, 6-3H]-niacin 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 [5, 6-3H]-niacin supplier is an individual or a company that provides [5, 6-3H]-niacin active pharmaceutical ingredient (API) or [5, 6-3H]-niacin finished formulations upon request. The [5, 6-3H]-niacin suppliers may include [5, 6-3H]-niacin API manufacturers, exporters, distributors and traders.
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A [5, 6-3H]-niacin CEP of the European Pharmacopoeia monograph is often referred to as a [5, 6-3H]-niacin Certificate of Suitability (COS). The purpose of a [5, 6-3H]-niacin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of [5, 6-3H]-niacin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of [5, 6-3H]-niacin to their clients by showing that a [5, 6-3H]-niacin CEP has been issued for it. The manufacturer submits a [5, 6-3H]-niacin CEP (COS) as part of the market authorization procedure, and it takes on the role of a [5, 6-3H]-niacin CEP holder for the record. Additionally, the data presented in the [5, 6-3H]-niacin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the [5, 6-3H]-niacin DMF.
A [5, 6-3H]-niacin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. [5, 6-3H]-niacin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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