01 1NOVO NORDISK PHARMATECH A/S Koege DK
01 1Benzalkonium chloride
01 1Denmark
01 1Valid
Certificate Number : R1-CEP 2001-298 - Rev 02
Status : Valid
Issue Date : 2015-10-16
Type : Chemical
Substance Number : 372
A Benzalkonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzalkonium, including repackagers and relabelers. The FDA regulates Benzalkonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzalkonium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzalkonium supplier is an individual or a company that provides Benzalkonium active pharmaceutical ingredient (API) or Benzalkonium finished formulations upon request. The Benzalkonium suppliers may include Benzalkonium API manufacturers, exporters, distributors and traders.
click here to find a list of Benzalkonium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzalkonium CEP of the European Pharmacopoeia monograph is often referred to as a Benzalkonium Certificate of Suitability (COS). The purpose of a Benzalkonium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benzalkonium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benzalkonium to their clients by showing that a Benzalkonium CEP has been issued for it. The manufacturer submits a Benzalkonium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benzalkonium CEP holder for the record. Additionally, the data presented in the Benzalkonium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benzalkonium DMF.
A Benzalkonium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benzalkonium 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 Benzalkonium suppliers with CEP (COS) on PharmaCompass.
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