01 1Croda International Plc
01 1CRODAMOL SE (REFINED DIETHYL SEBACATE)
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16694
Submission : 2003-06-30
Status : Inactive
Type : IV
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A Diethyl Sebacate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diethyl Sebacate, including repackagers and relabelers. The FDA regulates Diethyl Sebacate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diethyl Sebacate 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 Sebacate supplier is an individual or a company that provides Diethyl Sebacate active pharmaceutical ingredient (API) or Diethyl Sebacate finished formulations upon request. The Diethyl Sebacate suppliers may include Diethyl Sebacate API manufacturers, exporters, distributors and traders.
click here to find a list of Diethyl Sebacate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Diethyl Sebacate DMF (Drug Master File) is a document detailing the whole manufacturing process of Diethyl Sebacate active pharmaceutical ingredient (API) in detail. Different forms of Diethyl Sebacate DMFs exist exist since differing nations have different regulations, such as Diethyl Sebacate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diethyl Sebacate DMF submitted to regulatory agencies in the US is known as a USDMF. Diethyl Sebacate USDMF includes data on Diethyl Sebacate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diethyl Sebacate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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