01 1Xellia Pharmaceuticals ApS
01 1N-ACETYL-D-ALANINE
01 1Denmark
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32073
Submission : 2017-09-21
Status : Inactive
Type : IV
A N-Acetyl-D-Alanine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Acetyl-D-Alanine, including repackagers and relabelers. The FDA regulates N-Acetyl-D-Alanine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Acetyl-D-Alanine 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 N-Acetyl-D-Alanine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A N-Acetyl-D-Alanine supplier is an individual or a company that provides N-Acetyl-D-Alanine active pharmaceutical ingredient (API) or N-Acetyl-D-Alanine finished formulations upon request. The N-Acetyl-D-Alanine suppliers may include N-Acetyl-D-Alanine API manufacturers, exporters, distributors and traders.
click here to find a list of N-Acetyl-D-Alanine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-Acetyl-D-Alanine DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Acetyl-D-Alanine active pharmaceutical ingredient (API) in detail. Different forms of N-Acetyl-D-Alanine DMFs exist exist since differing nations have different regulations, such as N-Acetyl-D-Alanine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Acetyl-D-Alanine DMF submitted to regulatory agencies in the US is known as a USDMF. N-Acetyl-D-Alanine USDMF includes data on N-Acetyl-D-Alanine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Acetyl-D-Alanine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-Acetyl-D-Alanine suppliers with USDMF on PharmaCompass.
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