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