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