01 1JANSSEN PHARMACEUTICA NV Beerse BE
02 1Janssen Pharmaceutical Ltd County Cork IE
01 2Cisapride monohydrate
01 1Belgium
02 1U.S.A
01 2Withdrawn by Holder
Certificate Number : R1-CEP 1997-061 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2008-06-20
Type : Chemical
Substance Number : 995
Certificate Number : R1-CEP 1996-100 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2007-03-07
Type : Chemical
Substance Number : 995
A Cisapride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisapride Monohydrate, including repackagers and relabelers. The FDA regulates Cisapride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisapride Monohydrate 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 Cisapride Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisapride Monohydrate supplier is an individual or a company that provides Cisapride Monohydrate active pharmaceutical ingredient (API) or Cisapride Monohydrate finished formulations upon request. The Cisapride Monohydrate suppliers may include Cisapride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Cisapride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cisapride Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Cisapride Monohydrate Certificate of Suitability (COS). The purpose of a Cisapride Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cisapride Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cisapride Monohydrate to their clients by showing that a Cisapride Monohydrate CEP has been issued for it. The manufacturer submits a Cisapride Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cisapride Monohydrate CEP holder for the record. Additionally, the data presented in the Cisapride Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cisapride Monohydrate DMF.
A Cisapride Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cisapride Monohydrate 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 Cisapride Monohydrate suppliers with CEP (COS) on PharmaCompass.
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