01 1Siegfried AG
01 1MEPHENOXALONE- METHODS OF MANUF.
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 424
Submission : 1961-03-01
Status : Inactive
Type : II
A Mephenoxalone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mephenoxalone, including repackagers and relabelers. The FDA regulates Mephenoxalone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mephenoxalone 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 Mephenoxalone supplier is an individual or a company that provides Mephenoxalone active pharmaceutical ingredient (API) or Mephenoxalone finished formulations upon request. The Mephenoxalone suppliers may include Mephenoxalone API manufacturers, exporters, distributors and traders.
click here to find a list of Mephenoxalone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mephenoxalone DMF (Drug Master File) is a document detailing the whole manufacturing process of Mephenoxalone active pharmaceutical ingredient (API) in detail. Different forms of Mephenoxalone DMFs exist exist since differing nations have different regulations, such as Mephenoxalone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mephenoxalone DMF submitted to regulatory agencies in the US is known as a USDMF. Mephenoxalone USDMF includes data on Mephenoxalone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mephenoxalone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mephenoxalone suppliers with USDMF on PharmaCompass.
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