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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.
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Average Price (USD/KGS) |
Number of Transactions |
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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
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PharmaCompass offers a list of Ropivacaine 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 Ropivacaine Hydrochloride manufacturer or Ropivacaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ropivacaine Hydrochloride manufacturer or Ropivacaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ropivacaine Hydrochloride API Price utilized in the formulation of products. Ropivacaine Hydrochloride API Price is not always fixed or binding as the Ropivacaine Hydrochloride Price is obtained through a variety of data sources. The Ropivacaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ropivacaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ropivacaine Hydrochloride, including repackagers and relabelers. The FDA regulates Ropivacaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ropivacaine 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 Ropivacaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ropivacaine Hydrochloride supplier is an individual or a company that provides Ropivacaine Hydrochloride active pharmaceutical ingredient (API) or Ropivacaine Hydrochloride finished formulations upon request. The Ropivacaine Hydrochloride suppliers may include Ropivacaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ropivacaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ropivacaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ropivacaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ropivacaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ropivacaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ropivacaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ropivacaine Hydrochloride USDMF includes data on Ropivacaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ropivacaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ropivacaine 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 Ropivacaine Hydrochloride Drug Master File in Japan (Ropivacaine Hydrochloride JDMF) empowers Ropivacaine 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 Ropivacaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ropivacaine 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 Ropivacaine Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ropivacaine Hydrochloride Drug Master File in Korea (Ropivacaine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ropivacaine Hydrochloride. The MFDS reviews the Ropivacaine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ropivacaine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ropivacaine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ropivacaine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ropivacaine Hydrochloride suppliers with KDMF on PharmaCompass.
A Ropivacaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ropivacaine Hydrochloride Certificate of Suitability (COS). The purpose of a Ropivacaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ropivacaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ropivacaine Hydrochloride to their clients by showing that a Ropivacaine Hydrochloride CEP has been issued for it. The manufacturer submits a Ropivacaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ropivacaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Ropivacaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ropivacaine Hydrochloride DMF.
A Ropivacaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ropivacaine 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 Ropivacaine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Ropivacaine Hydrochloride written confirmation (Ropivacaine Hydrochloride WC) is an official document issued by a regulatory agency to a Ropivacaine Hydrochloride manufacturer, verifying that the manufacturing facility of a Ropivacaine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ropivacaine Hydrochloride APIs or Ropivacaine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ropivacaine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Ropivacaine Hydrochloride suppliers with Written Confirmation (WC) 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 Ropivacaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ropivacaine 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 Ropivacaine 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 Ropivacaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ropivacaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ropivacaine Hydrochloride suppliers with NDC on PharmaCompass.
Ropivacaine 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 Ropivacaine 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 Ropivacaine Hydrochloride GMP manufacturer or Ropivacaine Hydrochloride GMP API supplier for your needs.
A Ropivacaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ropivacaine Hydrochloride's compliance with Ropivacaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Ropivacaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ropivacaine 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.
Ropivacaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ropivacaine Hydrochloride EP), Ropivacaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ropivacaine Hydrochloride USP).
