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