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