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