01 1MACCO ORGANIQUES, S.R.O. Bruntál CZ
01 1Potassium sulfate
01 1Czech Republic
01 1Valid
Certificate Number : CEP 2023-390 - Rev 00
Status : Valid
Issue Date : 2024-09-20
Type : Chemical
Substance Number : 1622
A Potassium Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Sulfate, including repackagers and relabelers. The FDA regulates Potassium Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Sulfate 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 Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Sulfate supplier is an individual or a company that provides Potassium Sulfate active pharmaceutical ingredient (API) or Potassium Sulfate finished formulations upon request. The Potassium Sulfate suppliers may include Potassium Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Sulfate Certificate of Suitability (COS). The purpose of a Potassium Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Sulfate to their clients by showing that a Potassium Sulfate CEP has been issued for it. The manufacturer submits a Potassium Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Sulfate CEP holder for the record. Additionally, the data presented in the Potassium Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Sulfate DMF.
A Potassium Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Sulfate 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 Sulfate suppliers with CEP (COS) on PharmaCompass.
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