01 1Cilag AG
01 1EUDRAGITr E
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3170
Submission : 1978-02-08
Status : Inactive
Type : II
A Eudragit E manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eudragit E, including repackagers and relabelers. The FDA regulates Eudragit E manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eudragit E 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 Eudragit E supplier is an individual or a company that provides Eudragit E active pharmaceutical ingredient (API) or Eudragit E finished formulations upon request. The Eudragit E suppliers may include Eudragit E API manufacturers, exporters, distributors and traders.
click here to find a list of Eudragit E suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eudragit E DMF (Drug Master File) is a document detailing the whole manufacturing process of Eudragit E active pharmaceutical ingredient (API) in detail. Different forms of Eudragit E DMFs exist exist since differing nations have different regulations, such as Eudragit E USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eudragit E DMF submitted to regulatory agencies in the US is known as a USDMF. Eudragit E USDMF includes data on Eudragit E's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eudragit E USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eudragit E suppliers with USDMF on PharmaCompass.
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