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Naropin

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ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 16 USDMF, 12 CEP/COS, 1 JDMF, 12 EU WC, 5 KDMF, 12 NDC API, 34 Listed Suppliers, $ API Reference Price

49 API Suppliers
16 USDMF
12 CEP/COS
1 JDMF
12 EU WC
5 KDMF
12 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

INTERMEDIATES

12 Intermediates Suppliers

12 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 75 FDA Orange Book, 48 Europe, 6 Canada, 11 South Africa, 22 Listed Dossiers

162 FDF Dossiers
75 FDA Orange Book
48 Europe
6 Canada
11 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INJECTION - 100MG/10ML (10MG/ML), SOLUTION;INJECTION - 100MG/20ML (5MG/ML), SOLUTION;INJECTION - 150MG/30ML (5MG/ML), SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML), SOLUTION;INJECTION - 1GM/200ML (5MG/ML), SOLUTION;INJECTION - 200MG/20ML (10MG/ML), SOLUTION;INJECTION - 200MG/100ML (2MG/ML), SOLUTION;INJECTION - 20MG/10ML (2MG/ML), SOLUTION;INJECTION - 400MG/200ML (2MG/ML), SOLUTION;INJECTION - 40MG/20ML (2MG/ML), SOLUTION;INJECTION - 500MG/100ML (5MG/ML), SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
SOLUTION;INJECTION - 100MG/10ML (10MG/ML)
SOLUTION;INJECTION - 100MG/20ML (5MG/ML)
SOLUTION;INJECTION - 150MG/30ML (5MG/ML)
SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)
SOLUTION;INJECTION - 1GM/200ML (5MG/ML)
SOLUTION;INJECTION - 200MG/20ML (10MG/ML)
SOLUTION;INJECTION - 200MG/100ML (2MG/ML)
SOLUTION;INJECTION - 20MG/10ML (2MG/ML)
SOLUTION;INJECTION - 400MG/200ML (2MG/ML)
SOLUTION;INJECTION - 40MG/20ML (2MG/ML)
SOLUTION;INJECTION - 500MG/100ML (5MG/ML)
SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Actylis

relatedExcipients
3 Actylis

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 29 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
25 Finished Drug Prices

MARKET PLACE

17 APIs, 2 FDF Dossiers

marketPlace
17 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 14 Health Canada Patents

patents
6 US Patents
14 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 15 Others

otherSolutions
3 EDQM
3 USP
15 Others

Chemwerth Ropivacaine HCl

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,355

MARKET PLACE

API

FDF

12INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

162

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

8DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

4,977

Annual Reports (USD Million)

Finished Drug Prices

3 RELATED EXCIPIENT COMPANIES

3EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: 84057-95-4, (s)-ropivacaine, Naropin, Ropivacaine [inn], Ropivacaine hydrochloride, Ropivacaina

Molecular Formula

C₁₇H₂₆N₂O

Molecular Weight

274.4 g/mol

InChI Key

ZKMNUMMKYBVTFN-HNNXBMFYSA-N

FDA UNII

7IO5LYA57N

An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.

Ropivacaine is an Amide Local Anesthetic. The physiologic effect of ropivacaine is by means of Local Anesthesia.

1 2D Structure

Ropivacaine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide

2.1.2 InChI

InChI=1S/C17H26N2O/c1-4-11-19-12-6-5-10-15(19)17(20)18-16-13(2)8-7-9-14(16)3/h7-9,15H,4-6,10-12H2,1-3H3,(H,18,20)/t15-/m0/s1

2.1.3 InChI Key

ZKMNUMMKYBVTFN-HNNXBMFYSA-N

2.1.4 Canonical SMILES

CCCN1CCCCC1C(=O)NC2=C(C=CC=C2C)C

2.1.5 Isomeric SMILES

CCCN1CCCC[C@H]1C(=O)NC2=C(C=CC=C2C)C

2.2 Other Identifiers

2.2.1 UNII

7IO5LYA57N

2.3 Synonyms

2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₂₆N₂O
Molecular Weight	274.4 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

4.2 Drug Indication

Used in obstetric anesthesia and regional anesthesia for surgery.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

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.

5.2 MeSH Pharmacological Classification

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.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

ROPIVACAINE

5.3.2 FDA UNII

7IO5LYA57N

5.3.3 Pharmacological Classes

Amides [CS]; Local Anesthesia [PE]; Amide Local Anesthetic [EPC]

5.4 ATC Code

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

5.5 Absorption, Distribution and Excretion

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

5.6 Metabolism/Metabolites

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

5.7 Biological Half-Life

Approximately 4.2 hours.

5.8 Mechanism of Action

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

01

ChemWerth Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

Booth #12.1F43

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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U.S.A

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02

Shandong Chenghui Shuangda Pharmac...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI China

Attending

Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

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China

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USDMF CEP/COS

JDMF EU-WC

NDC KDMF VMF Others AUDIT

Shandong Chenghui Shuangda Pharmaceutical

03

Transo-Pharm USA LLC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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04

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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05

Aspen API

Netherlands

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Antibody Engineering

Not Confirmed

Aspen API. More than just an API.

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Netherlands

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USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

06

Moehs Iberica

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

Booth #11.0C6

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Spain

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KDMF VMF Others AUDIT

07

Aspen API

Netherlands

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Aspen API. More than just an API.

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Netherlands

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USDMF

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08

Fareva

Luxembourg

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

09

Recipharm AB

Sweden

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

10

Qilu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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DOSAGE - SOLUTION;INJECTION - 100MG/10ML (10M...DOSAGE - SOLUTION;INJECTION - 100MG/10ML (10MG/ML)