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01 1Siegfried AG
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01 1AMOROLFINE HYDROCHLORIDE
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01 1Switzerland
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01 1Inactive
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16254
Submission : 2002-11-19
Status : Inactive
Type : II
A Amorolfine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amorolfine, including repackagers and relabelers. The FDA regulates Amorolfine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amorolfine 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 Amorolfine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amorolfine supplier is an individual or a company that provides Amorolfine active pharmaceutical ingredient (API) or Amorolfine finished formulations upon request. The Amorolfine suppliers may include Amorolfine API manufacturers, exporters, distributors and traders.
click here to find a list of Amorolfine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amorolfine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amorolfine active pharmaceutical ingredient (API) in detail. Different forms of Amorolfine DMFs exist exist since differing nations have different regulations, such as Amorolfine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amorolfine DMF submitted to regulatory agencies in the US is known as a USDMF. Amorolfine USDMF includes data on Amorolfine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amorolfine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amorolfine suppliers with USDMF on PharmaCompass.
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