01 1ORGAMOL PHARMA SOLUTIONS SA
02 1Blank
01 1AMSACRINE
02 1m-AMSA
01 1Switzerland
02 1Blank
01 2Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7464
Submission : 1988-05-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6295
Submission : 1986-04-18
Status : Inactive
Type : II
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A Amsacrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amsacrine, including repackagers and relabelers. The FDA regulates Amsacrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amsacrine 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 Amsacrine supplier is an individual or a company that provides Amsacrine active pharmaceutical ingredient (API) or Amsacrine finished formulations upon request. The Amsacrine suppliers may include Amsacrine API manufacturers, exporters, distributors and traders.
click here to find a list of Amsacrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amsacrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amsacrine active pharmaceutical ingredient (API) in detail. Different forms of Amsacrine DMFs exist exist since differing nations have different regulations, such as Amsacrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amsacrine DMF submitted to regulatory agencies in the US is known as a USDMF. Amsacrine USDMF includes data on Amsacrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amsacrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amsacrine suppliers with USDMF on PharmaCompass.
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