01 3ACS DOBFAR SPA
02 1Akums Lifesciences
03 1Aurobindo Pharma Limited
04 2Fresenius Kabi AB Brunna
05 2GSK
06 1Kyongbo Pharmaceutical Co., Ltd
07 1Nectar Lifesciences
08 2Orchid Pharma
09 1Qilu Antibiotics Pharmaceutical Co., Ltd.
10 3Sandoz B2B
11 1Wockhardt
01 1BUFFERED CEFTAZIDIME PENTAHYDRATE, STERILE
02 1CEFTAZIDIME
03 1CEFTAZIDIME (STERILE)
04 1CEFTAZIDIME + AVIBACTAM (STERILE)
05 1CEFTAZIDIME DIHYDROCHLORIDE
06 3CEFTAZIDIME FOR INJECTION
07 1CEFTAZIDIME FOR INJECTION (STERILE BULK)
08 1CEFTAZIDIME FOR INJECTION (USP)
09 3CEFTAZIDIME FOR INJECTION USP (STERILE BULK)
10 1CEFTAZIDIME PENTAHYDRATE BULK DRUG SUBSTANCE
11 1CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM SODIUM STERILE (4:1)
12 1CEFTAZIDIME STERILE, BULK
13 1CTAZ-TBE (CEFTAZIDIME-TERT-BUTYLESTER)
14 1CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE)
01 1China
02 6India
03 3Italy
04 1South Korea
05 2Sweden
06 3Switzerland
07 2United Kingdom
01 14Active
02 4Inactive
01 5Complete
02 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13683
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17628
Submission : 2004-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24787
Submission : 2011-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2014-05-05
DMF Number : 20985
Submission : 2007-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24339
Submission : 2011-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-29
Pay. Date : 2024-02-23
DMF Number : 23294
Submission : 2009-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-10
Pay. Date : 2013-09-06
DMF Number : 20481
Submission : 2006-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13009
Submission : 1998-05-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7115
Submission : 1987-08-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16082
Submission : 2002-08-06
Status : Active
Type : II
A Fortum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fortum, including repackagers and relabelers. The FDA regulates Fortum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fortum 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 Fortum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fortum supplier is an individual or a company that provides Fortum active pharmaceutical ingredient (API) or Fortum finished formulations upon request. The Fortum suppliers may include Fortum API manufacturers, exporters, distributors and traders.
click here to find a list of Fortum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fortum DMF (Drug Master File) is a document detailing the whole manufacturing process of Fortum active pharmaceutical ingredient (API) in detail. Different forms of Fortum DMFs exist exist since differing nations have different regulations, such as Fortum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fortum DMF submitted to regulatory agencies in the US is known as a USDMF. Fortum USDMF includes data on Fortum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fortum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fortum suppliers with USDMF on PharmaCompass.
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