01 1MACCO ORGANIQUES, S.R.O. Bruntál CZ
01 1Sodium sulfate, anhydrous
01 1Czech Republic
01 1Valid
Certificate Number : R1-CEP 2015-374 - Rev 00
Status : Valid
Issue Date : 2022-03-18
Type : Chemical
Substance Number : 99
35
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A Glauber's salt (decahydrate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glauber's salt (decahydrate), including repackagers and relabelers. The FDA regulates Glauber's salt (decahydrate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glauber's salt (decahydrate) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Glauber's salt (decahydrate) supplier is an individual or a company that provides Glauber's salt (decahydrate) active pharmaceutical ingredient (API) or Glauber's salt (decahydrate) finished formulations upon request. The Glauber's salt (decahydrate) suppliers may include Glauber's salt (decahydrate) API manufacturers, exporters, distributors and traders.
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A Glauber's salt (decahydrate) CEP of the European Pharmacopoeia monograph is often referred to as a Glauber's salt (decahydrate) Certificate of Suitability (COS). The purpose of a Glauber's salt (decahydrate) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glauber's salt (decahydrate) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glauber's salt (decahydrate) to their clients by showing that a Glauber's salt (decahydrate) CEP has been issued for it. The manufacturer submits a Glauber's salt (decahydrate) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glauber's salt (decahydrate) CEP holder for the record. Additionally, the data presented in the Glauber's salt (decahydrate) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glauber's salt (decahydrate) DMF.
A Glauber's salt (decahydrate) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glauber's salt (decahydrate) 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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