Synopsis
Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 1 Propyl 2',6' Pipecoloxylidide
2. 1-propyl-2',6'-pipecoloxylidide
3. Al 381
4. Al-381
5. Al381
6. Lea 103
7. Lea-103
8. Lea103
9. Naropeine
10. Naropin
11. Ropivacaine Hydrochloride
12. Ropivacaine Monohydrochloride
13. Ropivacaine Monohydrochloride, (s)-isomer
1. 84057-95-4
2. (s)-ropivacaine
3. Naropin
4. Ropivacaine [inn]
5. Ropivacaine Hydrochloride
6. Ropivacaina
7. Ropivacainum
8. Ropivacaina [spanish]
9. (s)-n-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide
10. Ropivacainum [inn-latin]
11. Ropivacaina [inn-spanish]
12. (2s)-n-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide
13. Ropivicaine
14. 7io5lya57n
15. (-)-1-propyl-2',6'-pipecoloxylidide
16. Lea 103
17. Chebi:8890
18. Tlc590
19. (2s)-n-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide
20. (2s)-n-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide
21. Tlc-590
22. Ropivacaine (inn)
23. L-n-n-propylpipecolic Acid-2,6-xylidide
24. Lea-103
25. 2-piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-propyl-, (2s)-
26. S-ropivacaine
27. (s)-(-)-1-propyl-2',6'-pipecoloxylidide
28. 1-propyl-2',6'-pipecoloxylidide
29. Noropine
30. Narop
31. Lea-103 Hcl
32. Naropin (tn)
33. Ncgc00164597-01
34. Ropivacaine [inn:ban]
35. 98717-15-8
36. Unii-7io5lya57n
37. Ropivacaine Base
38. Mfcd00864425
39. Al-381
40. Ropivacaine [mi]
41. Ropivacaine [vandf]
42. Schembl33292
43. Ropivacaine [usp-rs]
44. Ropivacaine [who-dd]
45. Bidd:gt0203
46. Narop; Noropine; Lea-103
47. Gtpl7602
48. (-)-1-propyl-2',6'-dimethyl-2-piperidylcarboxyanilid
49. Chembl1077896
50. Dtxsid4040187
51. Zinc897002
52. Hy-b0563
53. Bbl102321
54. S5504
55. Stl556120
56. Akos017343283
57. Ccg-267197
58. Db00296
59. As-35173
60. Cs-0009514
61. R0251
62. C07532
63. D08490
64. Ab00698466-07
65. Ab00698466_10
66. 057r954
67. A840710
68. Q279504
69. (s)-(-)-1-propyl-2',6'-pipecoloxylidine
70. Q-201677
71. (-)-1-propyl-2',6'-dimethyl-2-piperidylcarboxyanilide
72. (s)-n-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide
73. (s)-(-)-1-propylpiperidine-2-carboxylic Acid (2,6-dimethylphenyl)amide
| Molecular Weight | 274.4 g/mol |
|---|---|
| Molecular Formula | C17H26N2O |
| XLogP3 | 2.9 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 4 |
| Exact Mass | 274.204513457 g/mol |
| Monoisotopic Mass | 274.204513457 g/mol |
| Topological Polar Surface Area | 32.3 Ų |
| Heavy Atom Count | 20 |
| Formal Charge | 0 |
| Complexity | 308 |
| 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 | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Naropin |
| PubMed Health | Ropivacaine (Injection) |
| Drug Classes | Anesthetic, Local |
| Drug Label | Naropin Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity an... |
| Active Ingredient | Ropivacaine hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 2mg/ml; 10mg/ml; 5mg/ml; 7.5mg/ml |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa |
| 2 of 2 | |
|---|---|
| Drug Name | Naropin |
| PubMed Health | Ropivacaine (Injection) |
| Drug Classes | Anesthetic, Local |
| Drug Label | Naropin Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity an... |
| Active Ingredient | Ropivacaine hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 2mg/ml; 10mg/ml; 5mg/ml; 7.5mg/ml |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa |
Used in obstetric anesthesia and regional anesthesia for surgery.
FDA Label
Ropivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Anesthetics, Local
Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)
N01BB09
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
N - Nervous system
N01 - Anesthetics
N01B - Anesthetics, local
N01BB - Amides
N01BB09 - Ropivacaine
Absorption
Bioavailability is 87%98% following epidural administration.
Route of Elimination
Ropivacaine is extensively metabolized in the liver, predominantly by aromatic hydroxylation mediated by cytochrome P4501A to 3-hydroxy ropivacaine. After a single IV dose approximately 37% of the total dose is excreted in the urine as both free and conjugated 3-hydroxy ropivacaine. In total, 86% of the ropivacaine dose is excreted in the urine after intravenous administration of which only 1% relates to unchanged drug.
Clearance
387+/- 107 mL/min
unbound plasma clearance=7.2 +/- 1.6 L/min
Hepatic
Ropivacaine has known human metabolites that include 3-hydroxy-ropivacaine and PPX.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
Approximately 4.2 hours.
Local anesthetics such as Ropivacaine block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. Specifically, they block the sodium-channel and decrease chances of depolarization and consequent action potentials. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2013-08-05
DMF Number : 20249
Submission : 2007-02-02
Status : Active
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-19
Pay. Date : 2016-11-18
DMF Number : 20654
Submission : 2007-07-03
Status : Active
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23239
Submission : 2009-11-02
Status : Active
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-22
Pay. Date : 2013-05-01
DMF Number : 18288
Submission : 2005-04-15
Status : Active
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-19
Pay. Date : 2021-04-23
DMF Number : 35568
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19084
Submission : 2005-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-02-25
DMF Number : 25506
Submission : 2011-11-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22023
Submission : 2008-09-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26650
Submission : 2012-12-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-05
Pay. Date : 2013-04-01
DMF Number : 24948
Submission : 2011-10-12
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
Date of Issue : 2023-05-30
Valid Till : 2026-05-29
Written Confirmation Number : SD230036
Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong, PR China
Ropivacaine Hydrochloride IH/Ropivacaine IH
Date of Issue : 2022-09-30
Valid Till : 2025-09-08
Written Confirmation Number : WC-0369
Address of the Firm : Plot No 1134, 1135, 1136,1137,11438,\\r\\n1144 A & 8,1138 A & 8, Padra Jambusar ...
ROPIVACAINE HYDROCHLORIDE BP/EP/USP
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0108
Address of the Firm : Plot No. 1408/1409, GIDC, Ankleshwar-393002, Bharuch Gujarat, India
Ropivacaine HCl Monohydrate EP
Date of Issue : 2019-12-03
Valid Till : 2022-07-21
Written Confirmation Number : WC-0135A
Address of the Firm : Survey No. 47, Paiki Sub Plot No. 1, Village Lodariyal, Taluka Sanand, Dist. Ahm...
Ropivacaine Hydrochloride MonoHydrate Ph.Eur
Date of Issue : 2019-07-22
Valid Till : 2022-07-02
Written Confirmation Number : WC-0135
Address of the Firm : Survey No. 47, Paiki Sub Plot No. 1, Village Lodariyal, Taluka Sanand, Dist. Ahm...
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm : D-24 and D24/1 MIDC Kurkumbh Tal. Daund, Dist Pune 413 802, Maharashtra State
Date of Issue : 2019-04-08
Valid Till : 2021-11-04
Written Confirmation Number : WC-092
Address of the Firm : Plot No. 18, 56, 57& 58, K.I.A.D.B Industrial Area, Nanjangud - 571 302, Mysore ...
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm : N-211/2/10, MIDC, Boisar, Dist-Thane-401506, Mahrashtra
ROPIVACAINE HCI MONOHYDRATE EP/Ropivacaine HCl USP
Date of Issue : 2019-09-12
Valid Till : 2022-09-11
Written Confirmation Number : WC-0174a1
Address of the Firm : Plot No, 6,7,8,20 &24, MIDC Industrial Area Badlapur Post Kulgaon, Dist Thane, 4...
Ropivacaine Hydrochloride Monohydrate (IH)
Date of Issue : 2019-09-12
Valid Till : 2021-09-11
Written Confirmation Number : WC-0174
Address of the Firm : Plot No, 6,7,8,20 &24, MIDC Industrial Area Badlapur Post Kulgaon, Dist Thane, 4...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INJECTION - 100MG/10ML (10M...DOSAGE - SOLUTION;INJECTION - 100MG/10ML (10MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 100MG/20ML (5MG...DOSAGE - SOLUTION;INJECTION - 100MG/20ML (5MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 150MG/30ML (5MG...DOSAGE - SOLUTION;INJECTION - 150MG/30ML (5MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 150MG/20ML (7.5...DOSAGE - SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 1GM/200ML (5MG/...DOSAGE - SOLUTION;INJECTION - 1GM/200ML (5MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 200MG/20ML (10M...DOSAGE - SOLUTION;INJECTION - 200MG/20ML (10MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 200MG/100ML (2M...DOSAGE - SOLUTION;INJECTION - 200MG/100ML (2MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 20MG/10ML (2MG/...DOSAGE - SOLUTION;INJECTION - 20MG/10ML (2MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 400MG/200ML (2M...DOSAGE - SOLUTION;INJECTION - 400MG/200ML (2MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 40MG/20ML (2MG/...DOSAGE - SOLUTION;INJECTION - 40MG/20ML (2MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 500MG/100ML (5M...DOSAGE - SOLUTION;INJECTION - 500MG/100ML (5MG/ML)
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 50MG/10ML (5MG/...DOSAGE - SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20533
DOSAGE - SOLUTION;INJECTION - 75MG/10ML (7.5M...DOSAGE - SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20533
Related Excipient Companies
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
LOOKING FOR A SUPPLIER?
