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01 1DIAMOPHINE HYDROCHLORIDE
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6161
Submission : 1985-11-04
Status : Inactive
Type : II
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A Heroin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heroin, including repackagers and relabelers. The FDA regulates Heroin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heroin 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 Heroin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Heroin supplier is an individual or a company that provides Heroin active pharmaceutical ingredient (API) or Heroin finished formulations upon request. The Heroin suppliers may include Heroin API manufacturers, exporters, distributors and traders.
click here to find a list of Heroin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Heroin DMF (Drug Master File) is a document detailing the whole manufacturing process of Heroin active pharmaceutical ingredient (API) in detail. Different forms of Heroin DMFs exist exist since differing nations have different regulations, such as Heroin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heroin DMF submitted to regulatory agencies in the US is known as a USDMF. Heroin USDMF includes data on Heroin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heroin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heroin suppliers with USDMF on PharmaCompass.
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