01 1F. Hoffmann-La Roche
01 1UNISOM CAPS(DOXYLAMINE USP)
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5509
Submission : 1984-08-17
Status : Inactive
Type : II
A Doxylamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doxylamine, including repackagers and relabelers. The FDA regulates Doxylamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doxylamine 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 Doxylamine supplier is an individual or a company that provides Doxylamine active pharmaceutical ingredient (API) or Doxylamine finished formulations upon request. The Doxylamine suppliers may include Doxylamine API manufacturers, exporters, distributors and traders.
click here to find a list of Doxylamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Doxylamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Doxylamine active pharmaceutical ingredient (API) in detail. Different forms of Doxylamine DMFs exist exist since differing nations have different regulations, such as Doxylamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Doxylamine DMF submitted to regulatory agencies in the US is known as a USDMF. Doxylamine USDMF includes data on Doxylamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Doxylamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Doxylamine suppliers with USDMF on PharmaCompass.
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