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