01 1Eastman Chemical Company
01 1DIETHYL PHTHALATE, NF
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11846
Submission : 1996-02-05
Status : Inactive
Type : II
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A Solvanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solvanol, including repackagers and relabelers. The FDA regulates Solvanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solvanol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Solvanol supplier is an individual or a company that provides Solvanol active pharmaceutical ingredient (API) or Solvanol finished formulations upon request. The Solvanol suppliers may include Solvanol API manufacturers, exporters, distributors and traders.
click here to find a list of Solvanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Solvanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Solvanol active pharmaceutical ingredient (API) in detail. Different forms of Solvanol DMFs exist exist since differing nations have different regulations, such as Solvanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solvanol DMF submitted to regulatory agencies in the US is known as a USDMF. Solvanol USDMF includes data on Solvanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solvanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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