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