01 1Curia
02 1HONOUR LAB LTD
03 1MSN Laboratories
01 3MONOMETHYL FUMARATE
01 2India
02 1U.S.A
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38520
Submission : 2023-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-18
Pay. Date : 2016-02-03
DMF Number : 30153
Submission : 2016-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31594
Submission : 2017-03-31
Status : Active
Type : II
A Monomethyl Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monomethyl Fumarate, including repackagers and relabelers. The FDA regulates Monomethyl Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monomethyl Fumarate 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 Monomethyl Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monomethyl Fumarate supplier is an individual or a company that provides Monomethyl Fumarate active pharmaceutical ingredient (API) or Monomethyl Fumarate finished formulations upon request. The Monomethyl Fumarate suppliers may include Monomethyl Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Monomethyl Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monomethyl Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Monomethyl Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Monomethyl Fumarate DMFs exist exist since differing nations have different regulations, such as Monomethyl Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monomethyl Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Monomethyl Fumarate USDMF includes data on Monomethyl Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monomethyl Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monomethyl Fumarate suppliers with USDMF on PharmaCompass.
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