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1. Acetate, Lysine
2. Enisyl
3. L Lysine
4. L-lysine
5. Lysine
6. Lysine Acetate
7. Lysine Hydrochloride
1. 657-27-2
2. L-lysine Monohydrochloride
3. Lysine Hydrochloride
4. L-lysine, Monohydrochloride
5. 10098-89-2
6. H-lys-oh.hcl
7. L-(+)-lysine Monohydrochloride
8. L-lysine Hcl
9. (s)-2,6-diaminohexanoic Acid Hydrochloride
10. Lysine Hcl
11. Lyamine
12. L-lysine Monohydrocholoride
13. L-lysinehydrochloride>99%
14. Lysine Hcl, L-
15. Darvyl
16. Enisyl
17. Lysion
18. (2s)-2,6-diaminohexanoic Acid Hydrochloride
19. L-gen
20. Jnj23q2com
21. Poly(l-lysine) Hydrochloride
22. Lysine, L-, Monohydrochloride
23. Lysine, Monohydrochloride
24. Chebi:53633
25. Nsc-9253
26. Mfcd00064564
27. L-lysine, Hydrochloride
28. (s)-2,6-diaminohexanoic Acid Hydrochloride(1:x)
29. (2s)-2,6-diaminohexanoic Acid;hydrochloride
30. Lysine Hydrochloride (van)
31. 28826-16-6
32. L-lysine Hydrochloride (van)
33. Lysine, Monohydrochloride, L-
34. L-lysine, Hydrochloride (1:?)
35. Nsc 9253
36. Einecs 211-519-9
37. Unii-jnj23q2com
38. L(+)-lysine Monohydrochloride
39. Ai3-52405
40. (s)-2,6-diaminohexanoic Acid Monohydrochloride
41. Einecs 233-234-9
42. Lysine Hydrochloride [usan:usp:jan]
43. L-lysine.hydrochloride
44. H-lys-oh⋅hcl
45. H-lys-oh?cl
46. L-lysine-hydrochloride
47. Lysine Hcl [inci]
48. Ec 211-519-9
49. Lysine Hydrochloride (usp)
50. L-lysine Hydrochloride,(s)
51. Schembl41761
52. L-lysine Hydrochloride Solution
53. L(+)-lysine Monohy-drochloride
54. Chembl2105886
55. Dtxsid9029198
56. L-lysine Hydrochloride (jp17)
57. L-lysine, Hydrochloride (1:1)
58. Lysine Hydrochloride [jan]
59. Pharmakon1600-01301003
60. Lysine Hydrochloride [usan]
61. Hy-n0470
62. Lysine Hydrochloride [vandf]
63. L-lysine Hydrochloride [jan]
64. Lysine Hydrochloride [mart.]
65. Lysine Monohydrochloride [mi]
66. Nsc760110
67. S3953
68. Lysine Hydrochloride [who-dd]
69. Akos015847945
70. Akos015892881
71. Am81901
72. Ccg-214725
73. Cs-7885
74. Nsc-760110
75. L-lysine Hydrochloride [usp-rs]
76. L-lysine Monohydrochloride [fcc]
77. Ac-23978
78. Bs-17408
79. Lysine Hydrochloride [ep Monograph]
80. Db-029969
81. L-lysine Monohydrochloride, P.a., 98.5%
82. Lysine Hydrochloride [usp Monograph]
83. L0071
84. L-lysine Hydrochloride, >=98%, Natural, Fg
85. Lysine Hydrochloride (l-lysine Hydrochloride)
86. D02279
87. D70613
88. M03093
89. 657l272
90. A800311
91. J-521652
92. L-alpha,epsilondiaminocaproic Acid Monohydrochloride
93. Q-100750
94. L-lysine Monohydrochloride, Bioultra, >=99.5% (at)
95. Q27124123
96. Z940713328
97. L-lysine Monohydrochloride, Reagent Grade, >=98% (hplc)
98. L-lysine Monohydrochloride, Saj Special Grade, >=99.0%
99. L-lysine Monohydrochloride, Vetec(tm) Reagent Grade, >=98%
100. H-lys-oh.hcl L-lysine Monohydrochloride (from Non-animal Source)
101. L-lysine Monohydrochloride, Cell Culture Reagent (h-l-lys-oh.hcl)
102. Lysine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
103. L-lysine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
104. L-lysine Monohydrochloride, Certified Reference Material, Tracecert(r)
105. L-lysine Hydrochloride Solution, 100 Mm Amino Acid In 0.1 M Hcl, Analytical Standard
106. L-lysine Monohydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
107. L-lysine Monohydrochloride, From Non-animal Source, Meets Ep, Jp, Usp Testing Specifications, Suitable For Cell Culture, 98.5-101.0%
108. L-lysine Monohydrochloride, Pharmagrade, Ajinomoto, Ep, Jp, Usp, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production, Suitable For Cell Culture
| Molecular Weight | 182.65 g/mol |
|---|---|
| Molecular Formula | C6H15ClN2O2 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 5 |
| Exact Mass | 182.0822054 g/mol |
| Monoisotopic Mass | 182.0822054 g/mol |
| Topological Polar Surface Area | 89.3 Ų |
| Heavy Atom Count | 11 |
| Formal Charge | 0 |
| Complexity | 106 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Certificate Number : R1-CEP 2003-057 - Rev 05
Issue Date : 2022-04-04
Type : Chemical
Substance Number : 930
Status : Valid
Registration Number : 226MF10123
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2014-06-18
Latest Date of Registration :
Registration Number : 225MF10189
Registrant's Address : 33, Rue de Verdun Ham, France
Initial Date of Registration : 2013-10-09
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17233
Submission : 2004-03-12
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-26
Pay. Date : 2021-02-23
DMF Number : 26280
Submission : 2012-08-02
Status : Active
Type : II
Certificate Number : R1-CEP 1998-065 - Rev 02
Issue Date : 2013-12-20
Type : Chemical
Substance Number : 930
Status : Valid
Registration Number : 223MF10042
Registrant's Address : No. 718, Rongle East Road, Songjiang District, Shanghai, People's Republic of China
Initial Date of Registration : 2011-03-10
Latest Date of Registration :
NDC Package Code : 72013-823
Start Marketing Date : 2008-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31651
Submission : 2017-04-20
Status : Active
Type : II
Certificate Number : R1-CEP 2012-249 - Rev 01
Issue Date : 2021-10-22
Type : Chemical
Substance Number : 930
Status : Valid
NDC Package Code : 17333-023
Start Marketing Date : 2002-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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 : 2171
Submission : 1973-10-24
Status : Inactive
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 : 1835
Submission : 1971-12-06
Status : Inactive
Type : II

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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Regulatory Info : Authorized
Registration Country : Spain
L-Lysine Hydrochloride; L-Arginine Hydrochloride
Brand Name : Lysakare
Dosage Form : Solution For Perfusion
Dosage Strength : 25G; 25 G
Packaging :
Approval Date : 2019-12-10
Application Number : 1191381001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Serine; Glucose Monohydrate; Sodium Chloride; Sodium Hydroxide; Phenylalanine; Tryptophane; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Threonine; Methionine; Ornitine Hydrochloride; Proline; Potassium Acetate; Sodium Acetate Trihydrate; Acetylcysteine; Lysine Hydrochloride; Valine; Alanine; Tyrosine; Arginine; Aspartic Acid; Zinc Acetate; Asparagine Monohydrate; Magnesium Chloride Hexahydrate; Sodium Dihydrogenophospate Dihydrate
Brand Name : Isoplasmal G Solution For Infusion
Dosage Form : Solution For Infusion
Dosage Strength :
Packaging :
Approval Date : 1994-03-01
Application Number : 59737
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Serine; Glucose Monohydrate; Sodium Chloride; Sodium Dihydrogen Phosphate; Sodium Hydroxide; Purified Soybean Oil; Phenylalanine; Tryptophan; Glutamic Acid; Glycine; Histidine Hydrochloride; Isoleucine; Leucine; Threonine; Methionine; Calcium Chloride Dihydrate; Proline; Magnesium Acetate Tetrahydrate; Potassium Acetate; Sodium Acetate Trihydrate; Lysine Hydrochloride; Valine; Alanine; Arginine; Aspartic Acid; Medium Chain Triglycerides; Zinc Acetate Dihydrate
Brand Name : Lipoflex Peri Emulsion For Infusion Efg
Dosage Form : Emulsion For Infusion
Dosage Strength :
Packaging :
Approval Date : 2017-09-18
Application Number : 82263
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Serine; Sodium Hydroxide; Disodium Phosphate Dodecahidrate; Phenylalanine; Tryptophan; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Threonine; Methionine; Proline; Potassium Acetate; Sodium Acetate Trihydrate; Lysine Hydrochloride; Valine; Alanine; Tyrosine; Arginine; Aspartic Acid; Magnesium Chloride Hexahydrate
Brand Name : Aminoplasmal B.Braun 10% E Solution For Infusion
Dosage Form : Solution For Infusion
Dosage Strength : 10%
Packaging :
Approval Date : 2005-09-23
Application Number : 67054
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Serine; Glucose Anhydrate; Potassium Phosphate; Sodium Chloride; Phenylalanine; Tryptophane; Glycine; Histidine; Isoleucine; Leucine; Threonine; Methionine; Calcium Chloride Dihydrate; Proline; Sodium Acetate Trihydrate; Lysine Hydrochloride; Valine; Alanine; Tyrosine; Arginine; Magnesium Chloride Hexahydrate
Brand Name : Clinimix N
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 1996-12-01
Application Number : 61218
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Serine; Anhydrous Glucose; Phenylalanine; Tryptophane; Glycine; Histidine; Isoleucine; Leucine; Threonine; Methionine; Proline; Lysine Hydrochloride; Valine; Alanine; Tyrosine; Arginine
Brand Name : Clinimix N
Dosage Form : Solution
Dosage Strength :
Packaging :
Approval Date : 1996-12-01
Application Number : 61212
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Serine; Phenylalanine; Tryptophane; Glycine; Histidine; Isoleucine; Leucine; Threonine; Methionine; Proline; Lysine Hydrochloride; Valine; Alanine; Tyrosine; Arginine
Brand Name : Synthamine
Dosage Form : Electrolyte-Free Infusion Solution
Dosage Strength :
Packaging :
Approval Date : 1989-04-01
Application Number : 58193
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Cancelled
Registration Country : Spain
Serine; Phenylalanine; Tryptophane; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Threonine; Methionine; Proline; Lysine Hydrochloride; Valine; Alanine; Arginine; Aspartic Acid; Cysteine Hydrochloride Hydrated; Taurine; Acetylytyrosine
Brand Name : Tauramin 12.6% Solution For Infusion
Dosage Form : Solution For Infusion
Dosage Strength : 12.6%
Packaging :
Approval Date : 2007-04-18
Application Number : 68639
Regulatory Info : Cancelled
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Carnitine Hydrochloride; Lysine Hydrochloride; Cyproheptadine Hydrochloride
Brand Name : Pranzo
Dosage Form : Oral Solution
Dosage Strength : 62.5MG; 1.25MG; 0.5MG
Packaging :
Approval Date : 1969-05-01
Application Number : 47944
Regulatory Info : Authorized
Registration Country : Spain

Regulatory Info : Allowed
Registration Country : Switzerland
Cholecalciferol; All-Rac-Alpha-Tocopheryl Acetate; Thiamine Hydrochloride; Riboflavin Sodium Phosphate; Pyridoxine Hydrochloride; Nicotinamide; Dexpanthenol; Calcium; Lysine Hydrochloride
Brand Name : Pharmaton Kiddi Vita
Dosage Form : Syrup
Dosage Strength :
Packaging :
Approval Date : 18/08/2004
Application Number : 56687
Regulatory Info : Allowed
Registration Country : Switzerland

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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
68
PharmaCompass offers a list of Lysine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lysine Hydrochloride manufacturer or Lysine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lysine Hydrochloride manufacturer or Lysine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Lysine Hydrochloride API Price utilized in the formulation of products. Lysine Hydrochloride API Price is not always fixed or binding as the Lysine Hydrochloride Price is obtained through a variety of data sources. The Lysine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The L-Lysine-Hydrochloride Drug Master File in Japan (L-Lysine-Hydrochloride JDMF) empowers L-Lysine-Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the L-Lysine-Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Lysine-Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of L-Lysine-Hydrochloride suppliers with JDMF on PharmaCompass.
A L-Lysine-Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a L-Lysine-Hydrochloride Certificate of Suitability (COS). The purpose of a L-Lysine-Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Lysine-Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Lysine-Hydrochloride to their clients by showing that a L-Lysine-Hydrochloride CEP has been issued for it. The manufacturer submits a L-Lysine-Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Lysine-Hydrochloride CEP holder for the record. Additionally, the data presented in the L-Lysine-Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Lysine-Hydrochloride DMF.
A L-Lysine-Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Lysine-Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of L-Lysine-Hydrochloride suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing L-Lysine-Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Lysine-Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture L-Lysine-Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain L-Lysine-Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Lysine-Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Lysine-Hydrochloride suppliers with NDC on PharmaCompass.
L-Lysine-Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of L-Lysine-Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right L-Lysine-Hydrochloride GMP manufacturer or L-Lysine-Hydrochloride GMP API supplier for your needs.
A L-Lysine-Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to L-Lysine-Hydrochloride's compliance with L-Lysine-Hydrochloride specifications and serves as a tool for batch-level quality control.
L-Lysine-Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each L-Lysine-Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
L-Lysine-Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Lysine-Hydrochloride EP), L-Lysine-Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Lysine-Hydrochloride USP).