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01 1Apicore LLC
02 1Lek Pharmaceuticals
03 1MSN Laboratories
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01 3FERUMOXYTOL
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01 2India
02 1Slovenia
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39032
Submission : 2023-10-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-11-21
DMF Number : 27718
Submission : 2013-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-25
Pay. Date : 2022-12-15
DMF Number : 37265
Submission : 2022-07-18
Status : Active
Type : II
A Feraheme manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Feraheme, including repackagers and relabelers. The FDA regulates Feraheme manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Feraheme 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 Feraheme manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Feraheme supplier is an individual or a company that provides Feraheme active pharmaceutical ingredient (API) or Feraheme finished formulations upon request. The Feraheme suppliers may include Feraheme API manufacturers, exporters, distributors and traders.
click here to find a list of Feraheme suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Feraheme DMF (Drug Master File) is a document detailing the whole manufacturing process of Feraheme active pharmaceutical ingredient (API) in detail. Different forms of Feraheme DMFs exist exist since differing nations have different regulations, such as Feraheme USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Feraheme DMF submitted to regulatory agencies in the US is known as a USDMF. Feraheme USDMF includes data on Feraheme's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Feraheme USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Feraheme suppliers with USDMF on PharmaCompass.
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