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01 1EVONIK OPERATIONS GMBH Essen DE
02 2Medichem, S.A. Sant Joan Despí ES
03 1AVA, INC. Willowbrook US
04 1BAJAJ HEALTHCARE LIMITED Thane (West) IN
05 1Bajaj Healthcare Limited Mumbai IN
06 1DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN
07 1R.N. LABORATORIES Mumbai IN
08 1XTTRIUM LABORATORIES, INC. Mount Prospect US
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01 8Chlorhexidine digluconate solution
02 1Chlorhexidine digluconate solution, CDG
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01 1Gabon
02 1Germany
03 3India
04 1Spain
05 1Switzerland
06 2U.S.A
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01 7Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
Chlorhexidine Digluconate Solution
Certificate Number : R1-CEP 2001-343 - Rev 05
Status : Valid
Issue Date : 2020-08-31
Type : Chemical
Substance Number : 658
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Chlorhexidine Digluconate Solution
Certificate Number : R1-CEP 1993-009 - Rev 04
Status : Valid
Issue Date : 2009-02-16
Type : Chemical
Substance Number : 658
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Chlorhexidine Digluconate Solution, CDG
Certificate Number : R1-CEP 2017-128 - Rev 00
Status : Valid
Issue Date : 2022-07-18
Type : Chemical
Substance Number : 658
Chlorhexidine Digluconate Solution
Certificate Number : CEP 2022-038 - Rev 00
Status : Valid
Issue Date : 2024-06-05
Type : Chemical
Substance Number : 658
Chlorhexidine Digluconate Solution
Certificate Number : CEP 2017-074 - Rev 02
Status : Valid
Issue Date : 2024-05-15
Type : Chemical
Substance Number : 658
Chlorhexidine Digluconate Solution
Certificate Number : R0-CEP 2005-076 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-12-20
Type : Chemical
Substance Number : 658
Chlorhexidine Digluconate Solution
Certificate Number : R1-CEP 2003-094 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2019-09-17
Type : Chemical
Substance Number : 658
Chlorhexidine Digluconate Solution
Certificate Number : R1-CEP 2006-171 - Rev 03
Status : Valid
Issue Date : 2022-08-19
Type : Chemical
Substance Number : 658
Chlorhexidine Digluconate Solution
Certificate Number : R0-CEP 2020-179 - Rev 00
Status : Valid
Issue Date : 2021-11-10
Type : Chemical
Substance Number : 658
A Hibitane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hibitane, including repackagers and relabelers. The FDA regulates Hibitane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hibitane 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 Hibitane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hibitane supplier is an individual or a company that provides Hibitane active pharmaceutical ingredient (API) or Hibitane finished formulations upon request. The Hibitane suppliers may include Hibitane API manufacturers, exporters, distributors and traders.
click here to find a list of Hibitane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hibitane CEP of the European Pharmacopoeia monograph is often referred to as a Hibitane Certificate of Suitability (COS). The purpose of a Hibitane CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hibitane EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hibitane to their clients by showing that a Hibitane CEP has been issued for it. The manufacturer submits a Hibitane CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hibitane CEP holder for the record. Additionally, the data presented in the Hibitane CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hibitane DMF.
A Hibitane CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hibitane CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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