01 1Croda
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
01 1DOTTISOL (ISOSORBIDE DIMETHYL ETHER)
02 1SUPER REFINED ARLASOLVE DMI (DIMETHYL ISOSORBIDE)
01 1Switzerland
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22402
Submission : 2009-01-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23571
Submission : 2010-03-16
Status : Active
Type : IV
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PharmaCompass offers a list of Isosorbide Dimethyl Ether 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 Isosorbide Dimethyl Ether manufacturer or Isosorbide Dimethyl Ether supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide Dimethyl Ether manufacturer or Isosorbide Dimethyl Ether supplier.
A dimethyl isosorbide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of dimethyl isosorbide, including repackagers and relabelers. The FDA regulates dimethyl isosorbide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. dimethyl isosorbide 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 dimethyl isosorbide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A dimethyl isosorbide supplier is an individual or a company that provides dimethyl isosorbide active pharmaceutical ingredient (API) or dimethyl isosorbide finished formulations upon request. The dimethyl isosorbide suppliers may include dimethyl isosorbide API manufacturers, exporters, distributors and traders.
click here to find a list of dimethyl isosorbide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A dimethyl isosorbide DMF (Drug Master File) is a document detailing the whole manufacturing process of dimethyl isosorbide active pharmaceutical ingredient (API) in detail. Different forms of dimethyl isosorbide DMFs exist exist since differing nations have different regulations, such as dimethyl isosorbide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A dimethyl isosorbide DMF submitted to regulatory agencies in the US is known as a USDMF. dimethyl isosorbide USDMF includes data on dimethyl isosorbide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The dimethyl isosorbide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of dimethyl isosorbide suppliers with USDMF on PharmaCompass.
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