01 1Merck KGaA Darmstadt DE
01 1Meglumine
01 1Germany
01 1Valid
Certificate Number : R1-CEP 2007-248 - Rev 02
Status : Valid
Issue Date : 2019-11-18
Type : Chemical
Substance Number : 2055
A Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meglumine, including repackagers and relabelers. The FDA regulates Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meglumine 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 Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meglumine supplier is an individual or a company that provides Meglumine active pharmaceutical ingredient (API) or Meglumine finished formulations upon request. The Meglumine suppliers may include Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meglumine CEP of the European Pharmacopoeia monograph is often referred to as a Meglumine Certificate of Suitability (COS). The purpose of a Meglumine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meglumine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meglumine to their clients by showing that a Meglumine CEP has been issued for it. The manufacturer submits a Meglumine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meglumine CEP holder for the record. Additionally, the data presented in the Meglumine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meglumine DMF.
A Meglumine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meglumine 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 Meglumine suppliers with CEP (COS) on PharmaCompass.
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