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