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1. Gepa-merz
2. L-ornithine-l-aspartate
3. Orn-asp
4. Ornithine Aspartate
5. Ornithylaspartate
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)
Molecular Weight | 265.26 g/mol |
---|---|
Molecular Formula | C9H19N3O6 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 7 |
Exact Mass | 265.12738533 g/mol |
Monoisotopic Mass | 265.12738533 g/mol |
Topological Polar Surface Area | 190 Ų |
Heavy Atom Count | 18 |
Formal Charge | 0 |
Complexity | 228 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35044
Submission : 2020-08-19
Status : Active
Type : II
NDC Package Code : 51593-5013
Start Marketing Date : 2021-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41004
Submission : 2024-12-23
Status : Active
Type : II
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : L-Ornithine L-aspartate
Dosage Form : Granules
Dosage Strength : 3G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/10ML
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Ukraine
Brand Name : Larnamin
Dosage Form : Concentrate for Solution for Injection
Dosage Strength : 500MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Ukraine
Brand Name : Larnamin
Dosage Form : Granules for Oral Solution
Dosage Strength :
Packaging : 3G/5G Sachet
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Granules
Dosage Strength : 3G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : L-Ornithine L-Aspartate
Dosage Form : Liquid Injection
Dosage Strength : 5GM/10ML
Packaging : 10 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Concentrate for Solution for Infusion
Dosage Strength : 5G/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Ukraine
Brand Name : Larnamin
Dosage Form : Concentrate for Solution for Injection
Dosage Strength : 500MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Ukraine
Brand Name : Larnamin
Dosage Form : Granules for Oral Solution
Dosage Strength :
Packaging : 3G/5G Sachet
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : L-Ornithine L-aspartat...
Dosage Form : Granules
Dosage Strength : 3G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Granules
Dosage Strength : 3G
Brand Name : L-Ornithine L-aspartat...
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/10ML
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Ampoule
Regulatory Info :
Dosage : Injection
Dosage Strength : 5MG/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Granules
Dosage Strength : 3G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Granules
Dosage Strength : 3G
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
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
Packaging : 10 ML
Regulatory Info :
Dosage : Liquid Injection
Dosage Strength : 5GM/10ML
Brand Name : L-Ornithine L-Aspartat...
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Concentrate for Soluti...
Dosage Strength : 5G/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage : Concentrate for Soluti...
Dosage Strength : 5G/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
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ABOUT THIS PAGE
13
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.
A L-Ornithin-L-aspartat; manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Ornithin-L-aspartat;, including repackagers and relabelers. The FDA regulates L-Ornithin-L-aspartat; manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Ornithin-L-aspartat; 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-Ornithin-L-aspartat; manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Ornithin-L-aspartat; supplier is an individual or a company that provides L-Ornithin-L-aspartat; active pharmaceutical ingredient (API) or L-Ornithin-L-aspartat; finished formulations upon request. The L-Ornithin-L-aspartat; suppliers may include L-Ornithin-L-aspartat; API manufacturers, exporters, distributors and traders.
click here to find a list of L-Ornithin-L-aspartat; suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Ornithin-L-aspartat; DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Ornithin-L-aspartat; active pharmaceutical ingredient (API) in detail. Different forms of L-Ornithin-L-aspartat; DMFs exist exist since differing nations have different regulations, such as L-Ornithin-L-aspartat; USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Ornithin-L-aspartat; DMF submitted to regulatory agencies in the US is known as a USDMF. L-Ornithin-L-aspartat; USDMF includes data on L-Ornithin-L-aspartat;'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Ornithin-L-aspartat; USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Ornithin-L-aspartat; suppliers with USDMF 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-Ornithin-L-aspartat; as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Ornithin-L-aspartat; 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-Ornithin-L-aspartat; 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-Ornithin-L-aspartat; and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Ornithin-L-aspartat; NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Ornithin-L-aspartat; suppliers with NDC on PharmaCompass.
L-Ornithin-L-aspartat; 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-Ornithin-L-aspartat; 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-Ornithin-L-aspartat; GMP manufacturer or L-Ornithin-L-aspartat; GMP API supplier for your needs.
A L-Ornithin-L-aspartat; CoA (Certificate of Analysis) is a formal document that attests to L-Ornithin-L-aspartat;'s compliance with L-Ornithin-L-aspartat; specifications and serves as a tool for batch-level quality control.
L-Ornithin-L-aspartat; CoA mostly includes findings from lab analyses of a specific batch. For each L-Ornithin-L-aspartat; 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-Ornithin-L-aspartat; may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Ornithin-L-aspartat; EP), L-Ornithin-L-aspartat; JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Ornithin-L-aspartat; USP).