01 1Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE
01 1Epinastine hydrochloride
01 1Germany
01 1Valid
Certificate Number : R1-CEP 2011-311 - Rev 01
Status : Valid
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 2411
A Flurinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flurinol, including repackagers and relabelers. The FDA regulates Flurinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flurinol 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 Flurinol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flurinol supplier is an individual or a company that provides Flurinol active pharmaceutical ingredient (API) or Flurinol finished formulations upon request. The Flurinol suppliers may include Flurinol API manufacturers, exporters, distributors and traders.
click here to find a list of Flurinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flurinol CEP of the European Pharmacopoeia monograph is often referred to as a Flurinol Certificate of Suitability (COS). The purpose of a Flurinol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flurinol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flurinol to their clients by showing that a Flurinol CEP has been issued for it. The manufacturer submits a Flurinol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flurinol CEP holder for the record. Additionally, the data presented in the Flurinol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flurinol DMF.
A Flurinol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flurinol 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 Flurinol suppliers with CEP (COS) on PharmaCompass.
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