01 1S D Fine Chem Limited
01 1ISOPROPYL ALCOHOL USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28715
Submission : 2014-10-03
Status : Active
Type : IV
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A Isopropenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isopropenol, including repackagers and relabelers. The FDA regulates Isopropenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isopropenol 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 Isopropenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Isopropenol supplier is an individual or a company that provides Isopropenol active pharmaceutical ingredient (API) or Isopropenol finished formulations upon request. The Isopropenol suppliers may include Isopropenol API manufacturers, exporters, distributors and traders.
click here to find a list of Isopropenol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Isopropenol DMF (Drug Master File) is a document detailing the whole manufacturing process of Isopropenol active pharmaceutical ingredient (API) in detail. Different forms of Isopropenol DMFs exist exist since differing nations have different regulations, such as Isopropenol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isopropenol DMF submitted to regulatory agencies in the US is known as a USDMF. Isopropenol USDMF includes data on Isopropenol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isopropenol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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