01 1SIGMA TAU
01 1ADENYLOSUCCINIC ACID
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3932
Submission : 1980-09-10
Status : Inactive
Type : II
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A adenylosuccinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of adenylosuccinate, including repackagers and relabelers. The FDA regulates adenylosuccinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. adenylosuccinate 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 adenylosuccinate supplier is an individual or a company that provides adenylosuccinate active pharmaceutical ingredient (API) or adenylosuccinate finished formulations upon request. The adenylosuccinate suppliers may include adenylosuccinate API manufacturers, exporters, distributors and traders.
click here to find a list of adenylosuccinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A adenylosuccinate DMF (Drug Master File) is a document detailing the whole manufacturing process of adenylosuccinate active pharmaceutical ingredient (API) in detail. Different forms of adenylosuccinate DMFs exist exist since differing nations have different regulations, such as adenylosuccinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A adenylosuccinate DMF submitted to regulatory agencies in the US is known as a USDMF. adenylosuccinate USDMF includes data on adenylosuccinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The adenylosuccinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of adenylosuccinate suppliers with USDMF on PharmaCompass.
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