01 1Laboratori Alchemia Srl Milano IT
02 1OLON S.P.A. Rodano IT
03 1ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN
01 3Ketotifen hydrogen fumarate
01 1China
02 2Italy
01 3Valid
Certificate Number : R1-CEP 2003-034 - Rev 03
Status : Valid
Issue Date : 2020-09-11
Type : Chemical
Substance Number : 1592
Certificate Number : CEP 2012-054 - Rev 04
Status : Valid
Issue Date : 2024-07-29
Type : Chemical
Substance Number : 1592
Certificate Number : R1-CEP 2004-269 - Rev 01
Status : Valid
Issue Date : 2017-05-19
Type : Chemical
Substance Number : 1592
A Ketotifen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketotifen, including repackagers and relabelers. The FDA regulates Ketotifen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketotifen 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 Ketotifen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketotifen supplier is an individual or a company that provides Ketotifen active pharmaceutical ingredient (API) or Ketotifen finished formulations upon request. The Ketotifen suppliers may include Ketotifen API manufacturers, exporters, distributors and traders.
click here to find a list of Ketotifen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketotifen CEP of the European Pharmacopoeia monograph is often referred to as a Ketotifen Certificate of Suitability (COS). The purpose of a Ketotifen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketotifen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketotifen to their clients by showing that a Ketotifen CEP has been issued for it. The manufacturer submits a Ketotifen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketotifen CEP holder for the record. Additionally, the data presented in the Ketotifen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketotifen DMF.
A Ketotifen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketotifen 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 Ketotifen suppliers with CEP (COS) on PharmaCompass.
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