01 1Pfizer Inc
01 1AT-125 (U-42,126) ANTI-TUMOR AGENT
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3566
Submission : 1979-07-20
Status : Inactive
Type : II
40
PharmaCompass offers a list of Acivicin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Acivicin manufacturer or Acivicin supplier for your needs.
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A (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid, including repackagers and relabelers. The FDA regulates (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid 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 (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid supplier is an individual or a company that provides (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid active pharmaceutical ingredient (API) or (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid finished formulations upon request. The (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid suppliers may include (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid API manufacturers, exporters, distributors and traders.
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A (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid active pharmaceutical ingredient (API) in detail. Different forms of (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid DMFs exist exist since differing nations have different regulations, such as (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid USDMF includes data on (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (alphaS,5S)-alpha-amino-3-chloro-4,5-dihydro-5-isoxazole acetic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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