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Also known as: 3230-94-2, L-ornithine-l-aspartate, L-ornithine l-aspartate salt, Ornithine aspartate, (s)-2,5-diaminopentanoic acid compound with (s)-2-aminosuccinic acid (1:1), Ornithine aseparate
Molecular Formula
C9H19N3O6
Molecular Weight
265.26  g/mol
InChI Key
IXUZXIMQZIMPSQ-ZBRNBAAYSA-N
FDA UNII
JA08T3B97O

L-Ornithine L-aspartate
1 2D Structure

L-Ornithine L-aspartate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-aminobutanedioic acid;(2S)-2,5-diaminopentanoic acid
2.1.2 InChI
InChI=1S/C5H12N2O2.C4H7NO4/c6-3-1-2-4(7)5(8)9;5-2(4(8)9)1-3(6)7/h4H,1-3,6-7H2,(H,8,9);2H,1,5H2,(H,6,7)(H,8,9)/t4-;2-/m00/s1
2.1.3 InChI Key
IXUZXIMQZIMPSQ-ZBRNBAAYSA-N
2.1.4 Canonical SMILES
C(CC(C(=O)O)N)CN.C(C(C(=O)O)N)C(=O)O
2.1.5 Isomeric SMILES
C(C[C@@H](C(=O)O)N)CN.C([C@@H](C(=O)O)N)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
JA08T3B97O
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gepa-merz

2. L-ornithine-l-aspartate

3. Orn-asp

4. Ornithine Aspartate

5. Ornithylaspartate

2.3.2 Depositor-Supplied Synonyms

1. 3230-94-2

2. L-ornithine-l-aspartate

3. L-ornithine L-aspartate Salt

4. Ornithine Aspartate

5. (s)-2,5-diaminopentanoic Acid Compound With (s)-2-aminosuccinic Acid (1:1)

6. Ornithine Aseparate

7. L-aspartic Acid, Compd. With L-ornithine (1:1)

8. (2s)-2-aminobutanedioic Acid;(2s)-2,5-diaminopentanoic Acid

9. Ornithine Aspartate (l-ornithine L-aspartate)

10. Mfcd00058084

11. Hepa-merz (tn)

12. Lola

13. Ruigan

14. Schembl361185

15. Dtxsid30883964

16. Bcp13530

17. Hy-a0282

18. Ornithine Aspartate [who-dd]

19. L-ornithine L-aspartate Salt, Powder

20. Akos015998595

21. L-ornithine-l-aspartate (salt)

22. Ornithine L-form Aspartate [mi]

23. As-12577

24. L-ornithine, L-aspartate (1:1)

25. Aspartic Acid Compd. With Ornithine

26. Cs-0019764

27. O0440

28. Ornithine, L-, L-aspartate (1:1)

29. D08303

30. D70545

31. A821231

32. Q-102756

33. Q27281401

34. (s)-2,5-diaminopentanoic Acid (s)-2-aminosuccinic Acid Salt

35. (s)-2,5-diaminopentanoicacidcompoundwith(s)-2-aminosuccinicacid(1:1)

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 265.26 g/mol
Molecular Formula C9H19N3O6
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass265.12738533 g/mol
Monoisotopic Mass265.12738533 g/mol
Topological Polar Surface Area190 Ų
Heavy Atom Count18
Formal Charge0
Complexity228
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

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GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240850L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"913.60","actualQuantity":"913.6","unit":"KGS","unitRateFc":"106.4","totalValueFC":"98129.2","currency":"EURO","unitRateINR":"9340.8","date":"21-Feb-2025","totalValueINR":"8533718.34","totalValueInUsd":"98129.2","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8487996","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240854L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1031.32","actualQuantity":"1031.32","unit":"KGS","unitRateFc":"106.4","totalValueFC":"110773.5","currency":"EURO","unitRateINR":"9340.8","date":"21-Feb-2025","totalValueINR":"9633312.6","totalValueInUsd":"110773.5","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8487996","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240855L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1025.00","actualQuantity":"1025","unit":"KGS","unitRateFc":"106.4","totalValueFC":"110094.6","currency":"EURO","unitRateINR":"9340.8","date":"21-Feb-2025","totalValueINR":"9574279","totalValueInUsd":"110094.6","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8487996","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241157L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"450.00","actualQuantity":"450","unit":"KGS","unitRateFc":"106.4","totalValueFC":"48334.2","currency":"EURO","unitRateINR":"9340.8","date":"22-Feb-2025","totalValueINR":"4203342","totalValueInUsd":"48334.2","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8511049","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241158L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1017.77","actualQuantity":"1017.77","unit":"KGS","unitRateFc":"106.4","totalValueFC":"109318.1","currency":"EURO","unitRateINR":"9340.8","date":"22-Feb-2025","totalValueINR":"9506745.3","totalValueInUsd":"109318.1","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8511049","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241161L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1085.55","actualQuantity":"1085.55","unit":"KGS","unitRateFc":"106.4","totalValueFC":"116598.3","currency":"EURO","unitRateINR":"9340.8","date":"22-Feb-2025","totalValueINR":"10139862.02","totalValueInUsd":"116598.3","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8511049","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241162L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"986.80","actualQuantity":"986.8","unit":"KGS","unitRateFc":"106.4","totalValueFC":"105991.6","currency":"EURO","unitRateINR":"9340.8","date":"22-Feb-2025","totalValueINR":"9217461.97","totalValueInUsd":"105991.6","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8511593","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241164L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1039.30","actualQuantity":"1039.3","unit":"KGS","unitRateFc":"106.4","totalValueFC":"111630.6","currency":"EURO","unitRateINR":"9340.8","date":"22-Feb-2025","totalValueINR":"9707851.87","totalValueInUsd":"111630.6","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"8511593","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749753000,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240767L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"982.50","actualQuantity":"982.5","unit":"KGS","unitRateFc":"107.7","totalValueFC":"106805.4","currency":"USD","unitRateINR":"9340.8","date":"13-Jun-2025","totalValueINR":"9177296.7","totalValueInUsd":"106805.4","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"2629752","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749753000,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240768L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"450.00","actualQuantity":"450","unit":"KGS","unitRateFc":"107.7","totalValueFC":"48918.5","currency":"USD","unitRateINR":"9340.8","date":"13-Jun-2025","totalValueINR":"4203342","totalValueInUsd":"48918.5","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"2629752","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749753000,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240769L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1083.04","actualQuantity":"1083.04","unit":"KGS","unitRateFc":"107.7","totalValueFC":"117734.9","currency":"USD","unitRateINR":"9340.8","date":"13-Jun-2025","totalValueINR":"10116416.91","totalValueInUsd":"117734.9","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"2629752","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756837800,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241161L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791241","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MODI MUNDIPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1085.55","actualQuantity":"1085.55","unit":"KGS","unitRateFc":"106.3","totalValueFC":"114874.5","currency":"N\/A","unitRateINR":"9340.8","date":"03-Sep-2025","totalValueINR":"10139862.02","totalValueInUsd":"114874.5","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"4277841","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FR ANKFURT AM MAIN Frankfurt am Main, , GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"}]
12-Feb-2022
03-Sep-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Europe

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01

Farmak JSC

Ukraine
VMX
Not Confirmed
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Farmak JSC

Ukraine
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VMX
Not Confirmed

L-Ornithine L-aspartate salt

Brand Name : Larnamin

Dosage Form : Concentrate for Solution for Injection

Dosage Strength : 500MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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02

Farmak JSC

Ukraine
VMX
Not Confirmed
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Farmak JSC

Ukraine
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VMX
Not Confirmed

L-Ornithine L-aspartate salt

Brand Name : Larnamin

Dosage Form : Granules for Oral Solution

Dosage Strength :

Packaging : 3G/5G Sachet

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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03

Farmak Sa

Ukraine
VMX
Not Confirmed
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Farmak Sa

Ukraine
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VMX
Not Confirmed

L-ornithine-L-aspartate

Brand Name : Larnamin

Dosage Form : Granule For Oral Solution

Dosage Strength :

Packaging :

Approval Date : 04-04-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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04

Farmak Sa

Ukraine
VMX
Not Confirmed
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Farmak Sa

Ukraine
arrow
VMX
Not Confirmed

L-ornithine-L-aspartate

Brand Name : Larnamin

Dosage Form : Granule For Oral Solution

Dosage Strength :

Packaging :

Approval Date : 04-04-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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05

Farmak Sa

Ukraine
VMX
Not Confirmed
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Farmak Sa

Ukraine
arrow
VMX
Not Confirmed

L-ornithine-L-aspartate

Brand Name : Larnamin

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength :

Packaging :

Approval Date : 27-06-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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06

Farmak Sa

Ukraine
VMX
Not Confirmed
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Farmak Sa

Ukraine
arrow
VMX
Not Confirmed

L-ornithine-L-aspartate

Brand Name : Larnamin

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength :

Packaging :

Approval Date : 27-06-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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07

VMX
Not Confirmed
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VMX
Not Confirmed

Ornithine Aspartate

Brand Name : Hepa-Merz

Dosage Form : Infusion Concentrate

Dosage Strength : 5g/10ml

Packaging :

Approval Date : 09/06/1982

Application Number : 42592

Regulatory Info : Allowed

Registration Country : Switzerland

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08

VMX
Not Confirmed
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VMX
Not Confirmed

Ornithine Aspartate

Brand Name : Hepa-Merz

Dosage Form : Granules

Dosage Strength : 3g

Packaging :

Approval Date : 10/03/1986

Application Number : 46430

Regulatory Info : Allowed

Registration Country : Switzerland

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

L-Ornithine L-aspartate

Brand Name : L-Ornithine L-aspartat...

Dosage Form : Granules

Dosage Strength : 3G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

L-Ornithine L-aspartate

Dosage : Granules

Dosage Strength : 3G

Brand Name : L-Ornithine L-aspartat...

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

02

VMX
Not Confirmed
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VMX
Not Confirmed

L-Ornithine L-aspartate salt

Brand Name :

Dosage Form : Injection

Dosage Strength : 5MG/10ML

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

VMX
Not Confirmed
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VMX
Not Confirmed

L-Ornithine L-aspartate salt

Dosage : Injection

Dosage Strength : 5MG/10ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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03

VMX
Not Confirmed
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VMX
Not Confirmed

L-Ornithine L-aspartate

Brand Name : L-Ornithine L-Aspartat...

Dosage Form : Liquid Injection

Dosage Strength : 5GM/10ML

Packaging : 10 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

VMX
Not Confirmed
arrow
arrow
VMX
Not Confirmed

L-Ornithine L-aspartate

Dosage : Liquid Injection

Dosage Strength : 5GM/10ML

Brand Name : L-Ornithine L-Aspartat...

Approval Date :

Application Number :

Registration Country : India

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04

Polifarma

Turkey
VMX
Not Confirmed
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Polifarma

Turkey
arrow
VMX
Not Confirmed

L-Ornithine L-aspartate

Brand Name :

Dosage Form : Concentrate for Soluti...

Dosage Strength : 5G/10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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04

Polifarma

Turkey
VMX
Not Confirmed
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Polifarma

Turkey
arrow
VMX
Not Confirmed

L-Ornithine L-aspartate

Dosage : Concentrate for Soluti...

Dosage Strength : 5G/10ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Turkey

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DATA COMPILATION #PharmaFlow

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

Impressions: 3632

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

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Looking for 3230-94-2 / L-Ornithine L-aspartate API manufacturers, exporters & distributors?

L-Ornithine L-aspartate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of L-Ornithine L-aspartate 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 L-Ornithine L-aspartate manufacturer or L-Ornithine L-aspartate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Ornithine L-aspartate manufacturer or L-Ornithine L-aspartate supplier.

PharmaCompass also assists you with knowing the L-Ornithine L-aspartate API Price utilized in the formulation of products. L-Ornithine L-aspartate API Price is not always fixed or binding as the L-Ornithine L-aspartate Price is obtained through a variety of data sources. The L-Ornithine L-aspartate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

L-Ornithine L-aspartate

Synonyms

3230-94-2, L-ornithine-l-aspartate, L-ornithine l-aspartate salt, Ornithine aspartate, (s)-2,5-diaminopentanoic acid compound with (s)-2-aminosuccinic acid (1:1), Ornithine aseparate

Cas Number

3230-94-2

Unique Ingredient Identifier (UNII)

JA08T3B97O

L-Ornithine L-aspartate Manufacturers

A L-Ornithine L-aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Ornithine L-aspartate, including repackagers and relabelers. The FDA regulates L-Ornithine L-aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Ornithine L-aspartate 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-Ornithine L-aspartate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

L-Ornithine L-aspartate Suppliers

A L-Ornithine L-aspartate supplier is an individual or a company that provides L-Ornithine L-aspartate active pharmaceutical ingredient (API) or L-Ornithine L-aspartate finished formulations upon request. The L-Ornithine L-aspartate suppliers may include L-Ornithine L-aspartate API manufacturers, exporters, distributors and traders.

click here to find a list of L-Ornithine L-aspartate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

L-Ornithine L-aspartate USDMF

A L-Ornithine L-aspartate DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Ornithine L-aspartate active pharmaceutical ingredient (API) in detail. Different forms of L-Ornithine L-aspartate DMFs exist exist since differing nations have different regulations, such as L-Ornithine L-aspartate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A L-Ornithine L-aspartate DMF submitted to regulatory agencies in the US is known as a USDMF. L-Ornithine L-aspartate USDMF includes data on L-Ornithine L-aspartate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Ornithine L-aspartate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of L-Ornithine L-aspartate suppliers with USDMF on PharmaCompass.

L-Ornithine L-aspartate GMP

L-Ornithine L-aspartate 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-Ornithine L-aspartate 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-Ornithine L-aspartate GMP manufacturer or L-Ornithine L-aspartate GMP API supplier for your needs.

L-Ornithine L-aspartate CoA

A L-Ornithine L-aspartate CoA (Certificate of Analysis) is a formal document that attests to L-Ornithine L-aspartate's compliance with L-Ornithine L-aspartate specifications and serves as a tool for batch-level quality control.

L-Ornithine L-aspartate CoA mostly includes findings from lab analyses of a specific batch. For each L-Ornithine L-aspartate 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-Ornithine L-aspartate may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Ornithine L-aspartate EP), L-Ornithine L-aspartate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Ornithine L-aspartate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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