01 1ACS DOBFAR S.P.A. Tribiano IT
02 1AUROBINDO PHARMA LIMITED Hyderabad IN
03 1FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT
04 1NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN
05 1ORCHID PHARMA LIMITED Alathur IN
06 1Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN
07 1SANDOZ GMBH Kundl AT
01 7Cefepime dihydrochloride monohydrate, Sterile
01 1China
02 1Germany
03 3India
04 2Italy
01 5Valid
02 2Withdrawn by Holder
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : R0-CEP 2023-021 - Rev 00
Status : Valid
Issue Date : 2023-07-27
Type : Chemical
Substance Number : 2126
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : R0-CEP 2007-134 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2013-02-07
Type : Chemical
Substance Number : 2126
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : R1-CEP 2007-205 - Rev 06
Status : Valid
Issue Date : 2022-11-07
Type : Chemical
Substance Number : 2126
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : R1-CEP 2012-242 - Rev 00
Status : Valid
Issue Date : 2019-08-16
Type : Chemical
Substance Number : 2126
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : CEP 2008-081 - Rev 03
Status : Valid
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 2126
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : R1-CEP 2011-286 - Rev 01
Status : Valid
Issue Date : 2021-12-21
Type : Chemical
Substance Number : 2126
Cefepime Dihydrochloride Monohydrate, Sterile
Certificate Number : R1-CEP 2008-212 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-02-23
Type : Chemical
Substance Number : 2126
A Cefepime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefepime, including repackagers and relabelers. The FDA regulates Cefepime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefepime 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 Cefepime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefepime supplier is an individual or a company that provides Cefepime active pharmaceutical ingredient (API) or Cefepime finished formulations upon request. The Cefepime suppliers may include Cefepime API manufacturers, exporters, distributors and traders.
click here to find a list of Cefepime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefepime CEP of the European Pharmacopoeia monograph is often referred to as a Cefepime Certificate of Suitability (COS). The purpose of a Cefepime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefepime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefepime to their clients by showing that a Cefepime CEP has been issued for it. The manufacturer submits a Cefepime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefepime CEP holder for the record. Additionally, the data presented in the Cefepime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefepime DMF.
A Cefepime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefepime 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 Cefepime suppliers with CEP (COS) on PharmaCompass.
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