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
A Niaspan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niaspan, including repackagers and relabelers. The FDA regulates Niaspan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niaspan 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 Niaspan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niaspan supplier is an individual or a company that provides Niaspan active pharmaceutical ingredient (API) or Niaspan finished formulations upon request. The Niaspan suppliers may include Niaspan API manufacturers, exporters, distributors and traders.
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A Niaspan CEP of the European Pharmacopoeia monograph is often referred to as a Niaspan Certificate of Suitability (COS). The purpose of a Niaspan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Niaspan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Niaspan to their clients by showing that a Niaspan CEP has been issued for it. The manufacturer submits a Niaspan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Niaspan CEP holder for the record. Additionally, the data presented in the Niaspan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Niaspan DMF.
A Niaspan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Niaspan 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 Niaspan suppliers with CEP (COS) on PharmaCompass.
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