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