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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 39330
Submission : 2024-04-30
Status : Active
Type : IV
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 : 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 Histidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Histidine, including repackagers and relabelers. The FDA regulates Histidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Histidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Histidine supplier is an individual or a company that provides Histidine active pharmaceutical ingredient (API) or Histidine finished formulations upon request. The Histidine suppliers may include Histidine API manufacturers, exporters, distributors and traders.
click here to find a list of Histidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Histidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Histidine active pharmaceutical ingredient (API) in detail. Different forms of Histidine DMFs exist exist since differing nations have different regulations, such as Histidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Histidine DMF submitted to regulatory agencies in the US is known as a USDMF. Histidine USDMF includes data on Histidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Histidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Histidine suppliers with USDMF on PharmaCompass.
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