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