01 2Ercros
02 1F.I.S. Fabbrica Italiana Sintetici
03 1HONOUR LAB LTD
04 1Interquim Mexico
05 1Quimica Sintetica
01 1FOSFOMYCIN PHENYLAMMONIUM SALT
02 1FOSFOMYCIN TROMETAMOL
03 1FOSFOMYCIN TROMETAMOL (TROMETHAMINE) PH EUR/USP
04 3FOSFOMYCIN TROMETHAMINE
01 1India
02 1Italy
03 1Mexico
04 3Spain
01 6Active
01 4Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-20
Pay. Date : 2016-12-22
DMF Number : 31195
Submission : 2017-02-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11582
Submission : 1995-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10891
Submission : 1994-04-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-21
Pay. Date : 2024-10-18
DMF Number : 40335
Submission : 2024-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-09-27
DMF Number : 31656
Submission : 2017-04-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-05
Pay. Date : 2018-12-06
DMF Number : 33294
Submission : 2018-11-02
Status : Active
Type : II
A Fosfomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin, including repackagers and relabelers. The FDA regulates Fosfomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin 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 Fosfomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosfomycin supplier is an individual or a company that provides Fosfomycin active pharmaceutical ingredient (API) or Fosfomycin finished formulations upon request. The Fosfomycin suppliers may include Fosfomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Fosfomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosfomycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosfomycin active pharmaceutical ingredient (API) in detail. Different forms of Fosfomycin DMFs exist exist since differing nations have different regulations, such as Fosfomycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosfomycin DMF submitted to regulatory agencies in the US is known as a USDMF. Fosfomycin USDMF includes data on Fosfomycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosfomycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosfomycin suppliers with USDMF on PharmaCompass.
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