01 1Synthelabo Tanabe Chimie
01 1DL-LYSINE ACETYLSALICYLATE
01 1France
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8468
Submission : 1990-03-12
Status : Inactive
Type : II
10
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A Aspisol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aspisol, including repackagers and relabelers. The FDA regulates Aspisol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aspisol 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 Aspisol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Aspisol supplier is an individual or a company that provides Aspisol active pharmaceutical ingredient (API) or Aspisol finished formulations upon request. The Aspisol suppliers may include Aspisol API manufacturers, exporters, distributors and traders.
click here to find a list of Aspisol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Aspisol DMF (Drug Master File) is a document detailing the whole manufacturing process of Aspisol active pharmaceutical ingredient (API) in detail. Different forms of Aspisol DMFs exist exist since differing nations have different regulations, such as Aspisol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aspisol DMF submitted to regulatory agencies in the US is known as a USDMF. Aspisol USDMF includes data on Aspisol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aspisol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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