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