01 1Apothecon Pharmaceuticals
02 1Biofer
03 1Cilag AG
04 1Emcure Pharmaceuticals
05 1Opocrin SpA
06 1Viatris
01 2SODIUM FERRIC GLUCONATE
02 3SODIUM FERRIC GLUCONATE COMPLEX
03 1SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
01 2India
02 2Italy
03 1Switzerland
04 1U.S.A
01 3Active
02 3Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18541
Submission : 2005-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17746
Submission : 2004-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17602
Submission : 2004-08-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21983
Submission : 2008-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17645
Submission : 2004-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34228
Submission : 2019-12-03
Status : Active
Type : II
A Sodium ferric gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium ferric gluconate, including repackagers and relabelers. The FDA regulates Sodium ferric gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium ferric gluconate 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 Sodium ferric gluconate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium ferric gluconate supplier is an individual or a company that provides Sodium ferric gluconate active pharmaceutical ingredient (API) or Sodium ferric gluconate finished formulations upon request. The Sodium ferric gluconate suppliers may include Sodium ferric gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium ferric gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium ferric gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium ferric gluconate active pharmaceutical ingredient (API) in detail. Different forms of Sodium ferric gluconate DMFs exist exist since differing nations have different regulations, such as Sodium ferric gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium ferric gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium ferric gluconate USDMF includes data on Sodium ferric gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium ferric gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium ferric gluconate suppliers with USDMF on PharmaCompass.
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