01 1Advanced Accelerator Applications
02 2Ajinomoto Company
03 1Mitsubishi Tanabe Pharma
04 2Pfizer Inc
05 1SAFC
06 1SIGMA TAU
07 1Sigma-Aldrich Corporation
08 1Blank
01 1L'-LYSINE MONOHYDROCHLORIDE
02 1L-LYSINE MONO HCl
03 4L-LYSINE MONOHYDROCHLORIDE
04 1L-LYSINE MONOHYDROCHLORIDE TABLETS
05 1LYSINE HYDROCHLORIDE (HCI)-ARGININE HYDROCHLORIDE (HCI), 2.5%, SOLUTION
06 1POLY-L-LYSINE HYDROCHLORIDE
07 1POLY-L-LYSINE HYDROCHLORIDE, SIGMA PRODUCT NUMBER P6837
01 1France
02 3Japan
03 5U.S.A
04 1Blank
01 3Active
02 7Inactive
01 2Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31023
Submission : 2016-09-26
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31651
Submission : 2017-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-26
Pay. Date : 2021-02-23
DMF Number : 26280
Submission : 2012-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1835
Submission : 1971-12-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2171
Submission : 1973-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 446
Submission : 1961-08-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17233
Submission : 2004-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3323
Submission : 1978-08-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12170
Submission : 1996-10-08
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5095
Submission : 1983-10-12
Status : Inactive
Type : II
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Corporate PDF
A L-Lysine-Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lysine-Hydrochloride, including repackagers and relabelers. The FDA regulates L-Lysine-Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Lysine-Hydrochloride 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-Lysine-Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Lysine-Hydrochloride supplier is an individual or a company that provides L-Lysine-Hydrochloride active pharmaceutical ingredient (API) or L-Lysine-Hydrochloride finished formulations upon request. The L-Lysine-Hydrochloride suppliers may include L-Lysine-Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lysine-Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Lysine-Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Lysine-Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of L-Lysine-Hydrochloride DMFs exist exist since differing nations have different regulations, such as L-Lysine-Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Lysine-Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. L-Lysine-Hydrochloride USDMF includes data on L-Lysine-Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Lysine-Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Lysine-Hydrochloride suppliers with USDMF on PharmaCompass.
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