01 1ACS DOBFAR SPA
02 3Aurobindo Pharma Limited
03 1Farmastur 2010, S.L.
04 2Istituto Biochimico Italiano Giovanni Lorenzini SpA
05 3Mustafa Nevzat Ilac Sanayi A S
06 1Qilu Tianhe Pharmaceutical Co., Ltd.
07 1Sandoz B2B
08 1Zhejiang Hisun Pharmaceutical
09 1Zhuhai United Laboratories Co ., Ltd.
01 1STERILE SULBACTAM SODIUM
02 1SULBACTAM SODIUM (NON-STERILE API)
03 2SULBACTAM SODIUM (NON-STERILE)
04 1SULBACTAM SODIUM (STERILE)
05 1SULBACTAM SODIUM STERILE
06 1SULBACTAM SODIUM STERILE USP
07 2SULBACTAM SODIUM USP
08 1SULBACTAM SODIUM USP (NON-STERILE BULK)
09 1SULBACTAM SODIUM USP (STERILE BULK)
10 1SULBACTAM SODIUM USP (STERILE) BULK
11 1SULBACTAM SODIUM USP (STERILE) PROCESS-II
12 1SULBACTAM SODIUM USP, NON-STERILE
01 3China
02 3India
03 3Italy
04 1Spain
05 1Switzerland
06 3Turkey
01 7Active
02 7Inactive
01 2Complete
02 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16452
Submission : 2003-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19608
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39513
Submission : 2024-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19805
Submission : 2006-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14974
Submission : 2000-08-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-23
Pay. Date : 2020-05-18
DMF Number : 34192
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17189
Submission : 2004-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16587
Submission : 2003-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-11
Pay. Date : 2015-05-26
DMF Number : 29231
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16532
Submission : 2003-04-01
Status : Inactive
Type : II
A Sulbactam Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulbactam Sodium, including repackagers and relabelers. The FDA regulates Sulbactam Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulbactam Sodium 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 Sulbactam Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulbactam Sodium supplier is an individual or a company that provides Sulbactam Sodium active pharmaceutical ingredient (API) or Sulbactam Sodium finished formulations upon request. The Sulbactam Sodium suppliers may include Sulbactam Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Sulbactam Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulbactam Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulbactam Sodium active pharmaceutical ingredient (API) in detail. Different forms of Sulbactam Sodium DMFs exist exist since differing nations have different regulations, such as Sulbactam Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulbactam Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Sulbactam Sodium USDMF includes data on Sulbactam Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulbactam Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulbactam Sodium suppliers with USDMF on PharmaCompass.
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