01 1ICROM S.R.L. Concorezzo IT
01 1Fluorescein Sodium
01 1Italy
01 1Valid
Certificate Number : R1-CEP 2017-121 - Rev 00
Status : Valid
Issue Date : 2023-07-03
Type : Chemical
Substance Number : 1213
A Fluorescein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorescein, including repackagers and relabelers. The FDA regulates Fluorescein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorescein 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 Fluorescein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluorescein supplier is an individual or a company that provides Fluorescein active pharmaceutical ingredient (API) or Fluorescein finished formulations upon request. The Fluorescein suppliers may include Fluorescein API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorescein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorescein CEP of the European Pharmacopoeia monograph is often referred to as a Fluorescein Certificate of Suitability (COS). The purpose of a Fluorescein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluorescein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluorescein to their clients by showing that a Fluorescein CEP has been issued for it. The manufacturer submits a Fluorescein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluorescein CEP holder for the record. Additionally, the data presented in the Fluorescein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluorescein DMF.
A Fluorescein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluorescein 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 Fluorescein suppliers with CEP (COS) on PharmaCompass.
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