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
A Isosorbide Dimethyl Ether manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Dimethyl Ether, including repackagers and relabelers. The FDA regulates Isosorbide Dimethyl Ether manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Dimethyl Ether 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 Isosorbide Dimethyl Ether supplier is an individual or a company that provides Isosorbide Dimethyl Ether active pharmaceutical ingredient (API) or Isosorbide Dimethyl Ether finished formulations upon request. The Isosorbide Dimethyl Ether suppliers may include Isosorbide Dimethyl Ether API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Dimethyl Ether suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isosorbide Dimethyl Ether DMF (Drug Master File) is a document detailing the whole manufacturing process of Isosorbide Dimethyl Ether active pharmaceutical ingredient (API) in detail. Different forms of Isosorbide Dimethyl Ether DMFs exist exist since differing nations have different regulations, such as Isosorbide Dimethyl Ether USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isosorbide Dimethyl Ether DMF submitted to regulatory agencies in the US is known as a USDMF. Isosorbide Dimethyl Ether USDMF includes data on Isosorbide Dimethyl Ether's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isosorbide Dimethyl Ether USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isosorbide Dimethyl Ether suppliers with USDMF on PharmaCompass.
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