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01 1PharmaZell GmbH Raubling DE
02 1Becton, Dickinson and Company Sparks US
03 1ICROM S.R.L. Concorezzo IT
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01 1Loeffler Medium, Product code: 292946
02 2Methylthioninium chloride hydrate
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01 1Germany
02 1Italy
03 1U.S.A
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01 3Valid
Methylthioninium Chloride Hydrate
Certificate Number : CEP 2023-129 - Rev 00
Status : Valid
Issue Date : 2024-09-27
Type : Chemical
Substance Number : 1132
Loeffler Medium, Product Code: 292946
Certificate Number : R1-CEP 2000-328 - Rev 02
Status : Valid
Issue Date : 2012-07-25
Type : TSE
Substance Number :
Methylthioninium Chloride Hydrate
Certificate Number : CEP 2022-296 - Rev 00
Status : Valid
Issue Date : 2023-12-18
Type : Chemical
Substance Number : 1132
A Methylene Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylene Blue, including repackagers and relabelers. The FDA regulates Methylene Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylene Blue 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 Methylene Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylene Blue supplier is an individual or a company that provides Methylene Blue active pharmaceutical ingredient (API) or Methylene Blue finished formulations upon request. The Methylene Blue suppliers may include Methylene Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Methylene Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylene Blue CEP of the European Pharmacopoeia monograph is often referred to as a Methylene Blue Certificate of Suitability (COS). The purpose of a Methylene Blue CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Methylene Blue EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Methylene Blue to their clients by showing that a Methylene Blue CEP has been issued for it. The manufacturer submits a Methylene Blue CEP (COS) as part of the market authorization procedure, and it takes on the role of a Methylene Blue CEP holder for the record. Additionally, the data presented in the Methylene Blue CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Methylene Blue DMF.
A Methylene Blue CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Methylene Blue 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 Methylene Blue suppliers with CEP (COS) on PharmaCompass.
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