Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
1. 1069-31-4
2. 2,5-diaminopentanoic Acid Hydrochloride
3. Dl-ornithine Monohydrochloride
4. H-dl-orn-oh.hcl
5. Dl-ornithine Hcl
6. Ornithine, Monohydrochloride
7. Dl-ornithine, Hydrochloride
8. Mfcd00065398
9. 2,5-diaminopentanoic Acid;hydrochloride
10. H-d-orn-oh Hcl
11. Ornithine, Hydrochloride (1:)
12. 22834-83-9
13. (+/-)-2,5-diaminopentanoic Acid Monohydrochloride
14. Ornithine Hcl
15. Nsc118360
16. Ornithine Dl-form Hcl
17. (2s)-2,5-diaminopentanoic Acid Hydrochloride
18. Mfcd00012917
19. Nsc-118360
20. Ornithine, Monohydrochloride, Dl-
21. Ornithine Dl-form Monohydrochloride
22. Einecs 213-956-0
23. Nsc 25163
24. Ai3-26557
25. Dl-ornithinexhydrochloride
26. Dl-ornithine Xhydrochloride
27. Dl-ornithine (hydrochloride)
28. Schembl534810
29. Sgcut00223
30. Wln: Z3yzvq &gh -l
31. Chembl1972294
32. Ornithine, Hydrochloride (1:1)
33. Dtxsid90920541
34. L-ornithine-13c5,15n2 Hcl
35. 1346617-00-2
36. Bcp13629
37. D(+)-2,5-diamino-pentanoic Acid
38. L(+)-2,5-diamino-pentanoic Acid
39. Nsc25163
40. To_000074
41. Ornithine Hydrochloride,(dl)
42. Ac1496
43. Nsc-25163
44. Nsc118361
45. Ornithine--hydrogen Chloride (1/1)
46. Akos008056531
47. Dl-ornithine Monohydrochloride, ~99%
48. Ccg-213889
49. Nsc-118361
50. (4-amino-1-carboxybutyl)azanium;chloride
51. 2,5-diaminovaleric Acid Monohydrochloride
52. As-12881
53. Sy005810
54. Sy007936
55. 2,5-bis(azanyl)pentanoic Acid Hydrochloride
56. 2,5-diaminopentanoic Acid Monohydrochloride
57. Db-040717
58. Db-048118
59. Am20080016
60. Cs-0136494
61. Ft-0625497
62. Ft-0625590
63. Ft-0627979
64. Ft-0673307
65. Ft-0695773
66. O0063
67. Dl-ornithine Monohydrochloride, >=99.0% (at)
68. A801537
69. A821021
70. J-001677
71. Z262221498
Molecular Weight | 168.62 g/mol |
---|---|
Molecular Formula | C5H13ClN2O2 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 4 |
Exact Mass | 168.0665554 g/mol |
Monoisotopic Mass | 168.0665554 g/mol |
Topological Polar Surface Area | 89.3 Ų |
Heavy Atom Count | 10 |
Formal Charge | 0 |
Complexity | 95 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
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 : 35111
Submission : 2021-01-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4729
Submission : 1982-12-02
Status : Inactive
Type : II
Market Place
Reply
11 Dec 2024
Reply
28 Jul 2022
Reply
07 Jul 2022
Reply
18 Nov 2021
Reply
05 Jan 2021
Reply
20 Oct 2020
Reply
16 Mar 2020
Reply
15 Dec 2018
ABOUT THIS PAGE
A DL-Ornithine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DL-Ornithine hydrochloride, including repackagers and relabelers. The FDA regulates DL-Ornithine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DL-Ornithine 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 DL-Ornithine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DL-Ornithine hydrochloride supplier is an individual or a company that provides DL-Ornithine hydrochloride active pharmaceutical ingredient (API) or DL-Ornithine hydrochloride finished formulations upon request. The DL-Ornithine hydrochloride suppliers may include DL-Ornithine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of DL-Ornithine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DL-Ornithine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of DL-Ornithine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of DL-Ornithine hydrochloride DMFs exist exist since differing nations have different regulations, such as DL-Ornithine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DL-Ornithine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. DL-Ornithine hydrochloride USDMF includes data on DL-Ornithine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DL-Ornithine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DL-Ornithine hydrochloride suppliers with USDMF on PharmaCompass.
DL-Ornithine 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 DL-Ornithine 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 DL-Ornithine hydrochloride GMP manufacturer or DL-Ornithine hydrochloride GMP API supplier for your needs.
A DL-Ornithine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to DL-Ornithine hydrochloride's compliance with DL-Ornithine hydrochloride specifications and serves as a tool for batch-level quality control.
DL-Ornithine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each DL-Ornithine 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.
DL-Ornithine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (DL-Ornithine hydrochloride EP), DL-Ornithine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DL-Ornithine hydrochloride USP).
LOOKING FOR A SUPPLIER?