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