01 1Priti Industries
02 3Tomita Pharmaceutical
01 1MAGALDRATE
02 1MAGALDRATE IP/BP/USP
03 1MAGALDRATE POWDER USP
04 1U.S.P. MAGALDRATE
01 1India
02 3Japan
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39249
Submission : 2023-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30140
Submission : 2015-12-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25272
Submission : 2011-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9016
Submission : 1991-03-12
Status : Inactive
Type : II
A Magaldrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magaldrate, including repackagers and relabelers. The FDA regulates Magaldrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magaldrate 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 Magaldrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magaldrate supplier is an individual or a company that provides Magaldrate active pharmaceutical ingredient (API) or Magaldrate finished formulations upon request. The Magaldrate suppliers may include Magaldrate API manufacturers, exporters, distributors and traders.
click here to find a list of Magaldrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Magaldrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Magaldrate active pharmaceutical ingredient (API) in detail. Different forms of Magaldrate DMFs exist exist since differing nations have different regulations, such as Magaldrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magaldrate DMF submitted to regulatory agencies in the US is known as a USDMF. Magaldrate USDMF includes data on Magaldrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magaldrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Magaldrate suppliers with USDMF on PharmaCompass.
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