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