01 1ACS DOBFAR SPA
02 1Antibioticos do Brasil Ltda
03 1Aurobindo Pharma Limited
04 1Nectar Lifesciences
05 1Qilu Antibiotics Pharmaceutical Co., Ltd.
06 1Sandoz B2B
01 1CEFEPIME FOR INJECTION
02 1CEFEPIME FOR INJECTION (STERILE BULK)
03 2CEFEPIME FOR INJECTION USP (STERILE BULK)
04 1CEFEPIME FOR INJECTION USP (STERILE BULK) DRUG SUBSTANCE
05 1Cefepime, unsterile
01 1Brazil
02 1China
03 2India
04 1Italy
05 1Switzerland
01 4Active
02 2Inactive
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-15
Pay. Date : 2016-07-05
DMF Number : 24395
Submission : 2011-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-14
DMF Number : 19806
Submission : 2006-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19755
Submission : 2006-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25913
Submission : 2012-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-17
Pay. Date : 2013-08-07
DMF Number : 25303
Submission : 2011-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21139
Submission : 2007-12-14
Status : Inactive
Type : II
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 DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefepime active pharmaceutical ingredient (API) in detail. Different forms of Cefepime DMFs exist exist since differing nations have different regulations, such as Cefepime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefepime DMF submitted to regulatory agencies in the US is known as a USDMF. Cefepime USDMF includes data on Cefepime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefepime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefepime suppliers with USDMF on PharmaCompass.
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