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