01 1Roche Diagnostics GmbH
02 1Blank
01 1DOXEPIN
02 1DOXEPIN USP XX
01 1Germany
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2410
Submission : 1975-02-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5076
Submission : 1983-05-24
Status : Inactive
Type : II
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A Doxepin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doxepin, including repackagers and relabelers. The FDA regulates Doxepin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doxepin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Doxepin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Doxepin supplier is an individual or a company that provides Doxepin active pharmaceutical ingredient (API) or Doxepin finished formulations upon request. The Doxepin suppliers may include Doxepin API manufacturers, exporters, distributors and traders.
click here to find a list of Doxepin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Doxepin DMF (Drug Master File) is a document detailing the whole manufacturing process of Doxepin active pharmaceutical ingredient (API) in detail. Different forms of Doxepin DMFs exist exist since differing nations have different regulations, such as Doxepin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Doxepin DMF submitted to regulatory agencies in the US is known as a USDMF. Doxepin USDMF includes data on Doxepin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Doxepin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Doxepin suppliers with USDMF on PharmaCompass.
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