01 1Akums Lifesciences
02 1Astellas Pharma
03 1Aurobindo Pharma Limited
04 1CSPC Pharmaceutical Group
05 1Covalent Laboratories Private Limited
06 1Kyongbo Pharmaceutical Co., Ltd
07 1Lupin Ltd
08 1Nectar Lifesciences
09 2Orchid Pharma
10 1Pfizer Inc
11 1Qilu Antibiotics Pharmaceutical Co., Ltd.
12 2Sandoz B2B
13 1Unimark Remedies Limited
01 6CEFIXIME
02 1CEFIXIME (PROCESS 2)
03 1CEFIXIME BULK
04 1CEFIXIME NON-STERILE
05 4CEFIXIME USP
06 1CEFIXIME USP (NON-STERILE DRUG SUBSTANCE)
07 1CEFIXIME, USP
01 2China
02 8India
03 1Japan
04 1South Korea
05 2Switzerland
06 1U.S.A
01 9Active
02 6Inactive
01 7Complete
02 8Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-29
Pay. Date : 2014-02-25
DMF Number : 23474
Submission : 2010-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9478
Submission : 1991-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-09-13
DMF Number : 26369
Submission : 2012-09-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-28
Pay. Date : 2016-10-19
DMF Number : 27121
Submission : 2013-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15996
Submission : 2002-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2012-12-17
DMF Number : 19307
Submission : 2006-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19960
Submission : 2006-11-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-11-28
Pay. Date : 2022-08-19
DMF Number : 36694
Submission : 2022-07-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-27
Pay. Date : 2013-09-19
DMF Number : 27527
Submission : 2013-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-09-27
DMF Number : 26047
Submission : 2012-06-08
Status : Active
Type : II
A Cefixime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefixime, including repackagers and relabelers. The FDA regulates Cefixime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefixime 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 Cefixime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefixime supplier is an individual or a company that provides Cefixime active pharmaceutical ingredient (API) or Cefixime finished formulations upon request. The Cefixime suppliers may include Cefixime API manufacturers, exporters, distributors and traders.
click here to find a list of Cefixime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefixime DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefixime active pharmaceutical ingredient (API) in detail. Different forms of Cefixime DMFs exist exist since differing nations have different regulations, such as Cefixime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefixime DMF submitted to regulatory agencies in the US is known as a USDMF. Cefixime USDMF includes data on Cefixime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefixime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefixime suppliers with USDMF on PharmaCompass.
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