01 1AMINO GmbH
02 1Rexim SA
03 1Sekisui Medical Co. Ltd
01 1N-ACETYL L-TYROSINE
02 2N-ACETYL-L-TYROSINE
01 1Germany
02 1Japan
03 1Poland
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12721
Submission : 1997-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7316
Submission : 1988-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-27
Pay. Date : 2021-01-12
DMF Number : 18133
Submission : 2005-03-01
Status : Active
Type : II
A N-Acetyl-L-Tyrosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Acetyl-L-Tyrosine, including repackagers and relabelers. The FDA regulates N-Acetyl-L-Tyrosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Acetyl-L-Tyrosine 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-L-Tyrosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A N-Acetyl-L-Tyrosine supplier is an individual or a company that provides N-Acetyl-L-Tyrosine active pharmaceutical ingredient (API) or N-Acetyl-L-Tyrosine finished formulations upon request. The N-Acetyl-L-Tyrosine suppliers may include N-Acetyl-L-Tyrosine API manufacturers, exporters, distributors and traders.
click here to find a list of N-Acetyl-L-Tyrosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-Acetyl-L-Tyrosine DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Acetyl-L-Tyrosine active pharmaceutical ingredient (API) in detail. Different forms of N-Acetyl-L-Tyrosine DMFs exist exist since differing nations have different regulations, such as N-Acetyl-L-Tyrosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Acetyl-L-Tyrosine DMF submitted to regulatory agencies in the US is known as a USDMF. N-Acetyl-L-Tyrosine USDMF includes data on N-Acetyl-L-Tyrosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Acetyl-L-Tyrosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-Acetyl-L-Tyrosine suppliers with USDMF on PharmaCompass.
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