01 1BIOSPECTRA, INC. Bangor US
01 1Potassium bromide
01 1U.S.A
01 1Valid
Certificate Number : CEP 2022-224 - Rev 00
Status : Valid
Issue Date : 2024-05-24
Type : Chemical
Substance Number : 184
A Potassium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Bromide, including repackagers and relabelers. The FDA regulates Potassium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Bromide 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 Potassium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Bromide supplier is an individual or a company that provides Potassium Bromide active pharmaceutical ingredient (API) or Potassium Bromide finished formulations upon request. The Potassium Bromide suppliers may include Potassium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Bromide CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Bromide Certificate of Suitability (COS). The purpose of a Potassium Bromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Bromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Bromide to their clients by showing that a Potassium Bromide CEP has been issued for it. The manufacturer submits a Potassium Bromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Bromide CEP holder for the record. Additionally, the data presented in the Potassium Bromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Bromide DMF.
A Potassium Bromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Bromide 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 Potassium Bromide suppliers with CEP (COS) on PharmaCompass.
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