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
13
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A Zephiran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zephiran, including repackagers and relabelers. The FDA regulates Zephiran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zephiran 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 Zephiran supplier is an individual or a company that provides Zephiran active pharmaceutical ingredient (API) or Zephiran finished formulations upon request. The Zephiran suppliers may include Zephiran API manufacturers, exporters, distributors and traders.
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A Zephiran CEP of the European Pharmacopoeia monograph is often referred to as a Zephiran Certificate of Suitability (COS). The purpose of a Zephiran CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zephiran EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zephiran to their clients by showing that a Zephiran CEP has been issued for it. The manufacturer submits a Zephiran CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zephiran CEP holder for the record. Additionally, the data presented in the Zephiran CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zephiran DMF.
A Zephiran CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zephiran 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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