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