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