01 1Sekisui Medical Co. Ltd
01 1N-ACETYL-DL-TRYPTOPHAN
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9923
Submission : 1992-10-23
Status : Active
Type : II
A N-ACETYL-DL-TRYPTOPHAN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-ACETYL-DL-TRYPTOPHAN, including repackagers and relabelers. The FDA regulates N-ACETYL-DL-TRYPTOPHAN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-ACETYL-DL-TRYPTOPHAN API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A N-ACETYL-DL-TRYPTOPHAN supplier is an individual or a company that provides N-ACETYL-DL-TRYPTOPHAN active pharmaceutical ingredient (API) or N-ACETYL-DL-TRYPTOPHAN finished formulations upon request. The N-ACETYL-DL-TRYPTOPHAN suppliers may include N-ACETYL-DL-TRYPTOPHAN API manufacturers, exporters, distributors and traders.
click here to find a list of N-ACETYL-DL-TRYPTOPHAN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-ACETYL-DL-TRYPTOPHAN DMF (Drug Master File) is a document detailing the whole manufacturing process of N-ACETYL-DL-TRYPTOPHAN active pharmaceutical ingredient (API) in detail. Different forms of N-ACETYL-DL-TRYPTOPHAN DMFs exist exist since differing nations have different regulations, such as N-ACETYL-DL-TRYPTOPHAN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-ACETYL-DL-TRYPTOPHAN DMF submitted to regulatory agencies in the US is known as a USDMF. N-ACETYL-DL-TRYPTOPHAN USDMF includes data on N-ACETYL-DL-TRYPTOPHAN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-ACETYL-DL-TRYPTOPHAN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-ACETYL-DL-TRYPTOPHAN suppliers with USDMF on PharmaCompass.
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