01 1AMINO GmbH
02 1AVT (Shanghai)
03 2Ajinomoto Company
04 1Mitsubishi Tanabe Pharma
05 1Synthelabo Tanabe Chimie
01 1KETOLEUCINE L-HISTIDINE SALT
02 4L-HISTIDINE
03 1L-HISTIDINE BASE
01 1China
02 1France
03 1Germany
04 3Japan
01 4Active
02 2Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31562
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39330
Submission : 2024-04-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39086
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40314
Submission : 2024-09-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1931
Submission : 1972-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5911
Submission : 1985-07-05
Status : Inactive
Type : II
A L-Histidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Histidine, including repackagers and relabelers. The FDA regulates L-Histidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Histidine 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 L-Histidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Histidine supplier is an individual or a company that provides L-Histidine active pharmaceutical ingredient (API) or L-Histidine finished formulations upon request. The L-Histidine suppliers may include L-Histidine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Histidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Histidine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Histidine active pharmaceutical ingredient (API) in detail. Different forms of L-Histidine DMFs exist exist since differing nations have different regulations, such as L-Histidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Histidine DMF submitted to regulatory agencies in the US is known as a USDMF. L-Histidine USDMF includes data on L-Histidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Histidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Histidine suppliers with USDMF on PharmaCompass.
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