01 1BK Giulini GmbH
02 1Forest Laboratories
03 1TIANJIN YAGUANG HIGH TECH DEVELOPMENT CO
04 1Wendeng Jinye Industrial
05 2Blank
01 1ALBRITESODIUM MONOFLUOROPHOSPHATE
02 1PHOSKADENT NA 211 (SODIUM MONOFLUOROPHOSPHATE)
03 3SODIUM MONOFLUOROPHOSPHATE
04 1SODIUM MONOFLUOROPHOSPHATE 76 MG. C.R. TABLETS
01 2China
02 1Germany
03 1U.S.A
04 2Blank
01 3Active
02 3Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6947
Submission : 1987-04-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7119
Submission : 1987-08-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22894
Submission : 2009-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33354
Submission : 2018-11-22
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5913
Submission : 1985-07-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 545
Submission : 1963-05-06
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Fluorophosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorophosphate, including repackagers and relabelers. The FDA regulates Fluorophosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorophosphate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Fluorophosphate supplier is an individual or a company that provides Fluorophosphate active pharmaceutical ingredient (API) or Fluorophosphate finished formulations upon request. The Fluorophosphate suppliers may include Fluorophosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorophosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorophosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorophosphate active pharmaceutical ingredient (API) in detail. Different forms of Fluorophosphate DMFs exist exist since differing nations have different regulations, such as Fluorophosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorophosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorophosphate USDMF includes data on Fluorophosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorophosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorophosphate suppliers with USDMF on PharmaCompass.
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