01 1Merck KGaA Darmstadt DE
01 1Urea
01 1Germany
01 1Valid
Certificate Number : R1-CEP 2011-045 - Rev 01
Status : Valid
Issue Date : 2017-11-09
Type : Chemical
Substance Number : 743
A Urea API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea API, including repackagers and relabelers. The FDA regulates Urea API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea API 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 Urea API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urea API supplier is an individual or a company that provides Urea API active pharmaceutical ingredient (API) or Urea API finished formulations upon request. The Urea API suppliers may include Urea API API manufacturers, exporters, distributors and traders.
click here to find a list of Urea API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Urea API CEP of the European Pharmacopoeia monograph is often referred to as a Urea API Certificate of Suitability (COS). The purpose of a Urea API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Urea API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Urea API to their clients by showing that a Urea API CEP has been issued for it. The manufacturer submits a Urea API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Urea API CEP holder for the record. Additionally, the data presented in the Urea API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Urea API DMF.
A Urea API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Urea API 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 Urea API suppliers with CEP (COS) on PharmaCompass.
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