01 2AMINO GmbH
02 3Ajinomoto Company
03 1Cambridge Isotope Laboratories
04 1Kyowa Hakko Bio
05 1Mitsubishi Tanabe Pharma
06 1SIGMA TAU
07 1SNJ Labs
08 1Sekisui Medical Co. Ltd
09 1Yoneyama Yakuhin Kogyo
01 1A-KETOANALOGUE TO LEUCINE CALCIUM SALT
02 8L-LEUCINE
03 1L-LEUCINE (U-13C6)
04 1L-LEUCINE DRUG SUBSTANCE
05 1L-LEUCINE FROM FERMENTATION
01 2Germany
02 1India
03 7Japan
04 2U.S.A
01 6Active
02 6Inactive
01 2Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31556
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 21761
Submission : 2008-07-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31258
Submission : 2016-12-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3828
Submission : 1980-06-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21618
Submission : 2008-05-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2622
Submission : 1976-02-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1275
Submission : 1968-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7223
Submission : 1987-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2778
Submission : 1976-10-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38243
Submission : 2023-04-03
Status : Active
Type : II
A L-Leucine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Leucine API, including repackagers and relabelers. The FDA regulates L-Leucine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Leucine API 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-Leucine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Leucine API supplier is an individual or a company that provides L-Leucine API active pharmaceutical ingredient (API) or L-Leucine API finished formulations upon request. The L-Leucine API suppliers may include L-Leucine API API manufacturers, exporters, distributors and traders.
click here to find a list of L-Leucine API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Leucine API DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Leucine API active pharmaceutical ingredient (API) in detail. Different forms of L-Leucine API DMFs exist exist since differing nations have different regulations, such as L-Leucine API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Leucine API DMF submitted to regulatory agencies in the US is known as a USDMF. L-Leucine API USDMF includes data on L-Leucine API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Leucine API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Leucine API suppliers with USDMF on PharmaCompass.
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