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