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