01 1Chaitanya Group
02 1Pharmacosmos AS
03 1SAFC
04 1West Bengal Chemicals Industries
01 124% IRON ISOMALTOSIDE POWDER
02 1CHO KIT 2 IRON CHELATOR SOLUTION
03 1FERROUS GLYCINE SULPHATE
04 1IRON PROTEIN SUCCINYLATE
01 1Denmark
02 2India
03 1U.S.A
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33718
Submission : 2019-05-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23246
Submission : 2009-11-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20550
Submission : 2007-05-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32618
Submission : 2018-04-06
Status : Active
Type : II
A Iron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iron, including repackagers and relabelers. The FDA regulates Iron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iron 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 Iron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iron supplier is an individual or a company that provides Iron active pharmaceutical ingredient (API) or Iron finished formulations upon request. The Iron suppliers may include Iron API manufacturers, exporters, distributors and traders.
click here to find a list of Iron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iron DMF (Drug Master File) is a document detailing the whole manufacturing process of Iron active pharmaceutical ingredient (API) in detail. Different forms of Iron DMFs exist exist since differing nations have different regulations, such as Iron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iron DMF submitted to regulatory agencies in the US is known as a USDMF. Iron USDMF includes data on Iron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iron suppliers with USDMF on PharmaCompass.
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