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