01 1BASF
01 1BIS-2-ETHYLHEXYL PHTHALATE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7307
Submission : 1988-01-29
Status : Inactive
Type : II
47
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A Diethylhexyl Phthalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diethylhexyl Phthalate, including repackagers and relabelers. The FDA regulates Diethylhexyl Phthalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diethylhexyl 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 Diethylhexyl Phthalate supplier is an individual or a company that provides Diethylhexyl Phthalate active pharmaceutical ingredient (API) or Diethylhexyl Phthalate finished formulations upon request. The Diethylhexyl Phthalate suppliers may include Diethylhexyl Phthalate API manufacturers, exporters, distributors and traders.
click here to find a list of Diethylhexyl Phthalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Diethylhexyl Phthalate DMF (Drug Master File) is a document detailing the whole manufacturing process of Diethylhexyl Phthalate active pharmaceutical ingredient (API) in detail. Different forms of Diethylhexyl Phthalate DMFs exist exist since differing nations have different regulations, such as Diethylhexyl Phthalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diethylhexyl Phthalate DMF submitted to regulatory agencies in the US is known as a USDMF. Diethylhexyl Phthalate USDMF includes data on Diethylhexyl Phthalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diethylhexyl Phthalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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