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01 1MIDAS PHARMA GMBH Ingelheim am Rhein DE
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01 1Methylaminolevulinate hydrochloride
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01 1Germany
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01 1Valid
Methylaminolevulinate Hydrochloride
Certificate Number : R0-CEP 2022-127 - Rev 01
Status : Valid
Issue Date : 2022-05-06
Type : Chemical
Substance Number : 3073
31
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A Metvixia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metvixia, including repackagers and relabelers. The FDA regulates Metvixia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metvixia 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 Metvixia supplier is an individual or a company that provides Metvixia active pharmaceutical ingredient (API) or Metvixia finished formulations upon request. The Metvixia suppliers may include Metvixia API manufacturers, exporters, distributors and traders.
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A Metvixia CEP of the European Pharmacopoeia monograph is often referred to as a Metvixia Certificate of Suitability (COS). The purpose of a Metvixia CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Metvixia EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Metvixia to their clients by showing that a Metvixia CEP has been issued for it. The manufacturer submits a Metvixia CEP (COS) as part of the market authorization procedure, and it takes on the role of a Metvixia CEP holder for the record. Additionally, the data presented in the Metvixia CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Metvixia DMF.
A Metvixia CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Metvixia 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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