01 1Finar
02 1Polymed Therapeutics Inc.
01 1ENCEQUIDAR METHANESULFONATE MONOHYDRATE DRUG SUBSTANCE
02 1METHANE SULPHONIC ACID HP
01 1India
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32834
Submission : 2018-05-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34578
Submission : 2020-03-12
Status : Inactive
Type : II
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PharmaCompass offers a list of Methanesulphonic acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Methanesulphonic acid manufacturer or Methanesulphonic acid supplier for your needs.
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A Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mesylate, including repackagers and relabelers. The FDA regulates Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mesylate 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 Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Mesylate supplier is an individual or a company that provides Mesylate active pharmaceutical ingredient (API) or Mesylate finished formulations upon request. The Mesylate suppliers may include Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Mesylate DMFs exist exist since differing nations have different regulations, such as Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Mesylate USDMF includes data on Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mesylate suppliers with USDMF on PharmaCompass.
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