01 2Bayer AG
01 1EDRUL TABS (20,30 & 240MG)
02 1MUZOLIMINE SEMIHYDRATE
01 2Germany
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6172
Submission : 1986-01-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6166
Submission : 1986-01-10
Status : Inactive
Type : II
A Muzolimine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Muzolimine, including repackagers and relabelers. The FDA regulates Muzolimine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Muzolimine 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 Muzolimine supplier is an individual or a company that provides Muzolimine active pharmaceutical ingredient (API) or Muzolimine finished formulations upon request. The Muzolimine suppliers may include Muzolimine API manufacturers, exporters, distributors and traders.
click here to find a list of Muzolimine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Muzolimine DMF (Drug Master File) is a document detailing the whole manufacturing process of Muzolimine active pharmaceutical ingredient (API) in detail. Different forms of Muzolimine DMFs exist exist since differing nations have different regulations, such as Muzolimine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Muzolimine DMF submitted to regulatory agencies in the US is known as a USDMF. Muzolimine USDMF includes data on Muzolimine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Muzolimine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Muzolimine suppliers with USDMF on PharmaCompass.
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