01 1Novartis Pharmaceuticals Corporation
01 1EUDRAGITr RL/RS
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7810
Submission : 1988-12-20
Status : Inactive
Type : II
A Eudragit Rs manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eudragit Rs, including repackagers and relabelers. The FDA regulates Eudragit Rs manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eudragit Rs 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 Rs supplier is an individual or a company that provides Eudragit Rs active pharmaceutical ingredient (API) or Eudragit Rs finished formulations upon request. The Eudragit Rs suppliers may include Eudragit Rs API manufacturers, exporters, distributors and traders.
click here to find a list of Eudragit Rs suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eudragit Rs DMF (Drug Master File) is a document detailing the whole manufacturing process of Eudragit Rs active pharmaceutical ingredient (API) in detail. Different forms of Eudragit Rs DMFs exist exist since differing nations have different regulations, such as Eudragit Rs USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eudragit Rs DMF submitted to regulatory agencies in the US is known as a USDMF. Eudragit Rs USDMF includes data on Eudragit Rs's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eudragit Rs USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eudragit Rs suppliers with USDMF on PharmaCompass.
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