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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

Ropivacaine Hydrochloride
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 Weight 274.4 g/mol
Molecular Formula C17H26N2O
XLogP32.9
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count4
Exact Mass274.204513457 g/mol
Monoisotopic Mass274.204513457 g/mol
Topological Polar Surface Area32.3 Ų
Heavy Atom Count20
Formal Charge0
Complexity308
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameNaropin
PubMed HealthRopivacaine (Injection)
Drug ClassesAnesthetic, Local
Drug LabelNaropin 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 IngredientRopivacaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength2mg/ml; 10mg/ml; 5mg/ml; 7.5mg/ml
Market StatusPrescription
CompanyFresenius Kabi Usa

2 of 2  
Drug NameNaropin
PubMed HealthRopivacaine (Injection)
Drug ClassesAnesthetic, Local
Drug LabelNaropin 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 IngredientRopivacaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength2mg/ml; 10mg/ml; 5mg/ml; 7.5mg/ml
Market StatusPrescription
CompanyFresenius 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.


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Certificate Number : R1-CEP 2012-281 - Rev 00

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Ropivacaine hydrochloride hydrate

Registration Number : 305MF10079

Registrant's Address : No. 29 Huayuan Street Linyi County, Dezhou, Shandong, China

Initial Date of Registration : 2023-07-12

Latest Date of Registration : 2023-07-12

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Ropivacaine Hydrochloride

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

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Ropivacaine Hydrochloride IH/Ropivacaine IH

Date of Issue : 2022-09-30

Valid Till : 2025-09-08

Written Confirmation Number : WC-0369n

Address of the Firm : Plot No 1134, 1135, 1136,1137,11438, RN 1144 A & 8,1138 A & 8, Padra Jambusar Hi...

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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 

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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...

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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...

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Ropivacaine HCl USP

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

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Ropivacaine Hydrochloride USP

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 ...

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Ropivacaine HCl

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

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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...

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BIO Partnering at JPM
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BIO Partnering at JPM
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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...

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LIMITED","customerCountry":"INDIA","quantity":"64.99","actualQuantity":"64.99","unit":"KGS","unitRateFc":"2400","totalValueFC":"157701.4","currency":"USD","unitRateINR":"201960","date":"07-Oct-2023","totalValueINR":"13125380.4","totalValueInUsd":"157701.4","indian_port":"Madras Air","hs_no":"29420090","bill_no":"8194916","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"DUESSELDORF","supplierAddress":"61 SOUTH PARAMUS ROAD SUITE 565PARAMUS NEW JERSEYSDNF US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702233000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2400","totalValueFC":"2430.5","currency":"USD","unitRateINR":"202320","date":"11-Dec-2023","totalValueINR":"202320","totalValueInUsd":"2430.5","indian_port":"Madras Air","hs_no":"29420090","bill_no":"9164814","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD SUITE 565PARAMUS NEW JERSEYSDNF US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702233000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"9.90","actualQuantity":"9.9","unit":"KGS","unitRateFc":"2400","totalValueFC":"24061.7","currency":"USD","unitRateINR":"202320","date":"11-Dec-2023","totalValueINR":"2002968","totalValueInUsd":"24061.7","indian_port":"Madras Air","hs_no":"29420090","bill_no":"9164814","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD SUITE 565PARAMUS NEW JERSEYSDNF US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704911400,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"UNITED STATES","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"2400","totalValueFC":"121643.5","currency":"USD","unitRateINR":"202200","date":"11-Jan-2024","totalValueINR":"10110000","totalValueInUsd":"121643.5","indian_port":"Madras Air","hs_no":"29420090","bill_no":"9620987","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565Paramus, New Jersey 07652USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704997800,"product":"(FOC) - ROPIVACAINE HYDROCHLORIDE MONOHYDRATE - 14","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"INTER CHEM CORPORATION A PHARMASPHERE COMPANY","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"145.40","actualQuantity":"145.4","unit":"KGS","unitRateFc":"1800","totalValueFC":"265304.5","currency":"USD","unitRateINR":"151650","date":"12-Jan-2024","totalValueINR":"22049910","totalValueInUsd":"265304.5","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"9639980","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"223 PERUVIAN AVENUE PALM BEACH FL 33480 USA New York, , United StatesSDNF United States","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706553000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"4.91","actualQuantity":"4.91","unit":"KGS","unitRateFc":"2400","totalValueFC":"11924.1","currency":"USD","unitRateINR":"201840","date":"30-Jan-2024","totalValueINR":"991034.4","totalValueInUsd":"11924.1","indian_port":"Madras Air","hs_no":"29420090","bill_no":"9899383","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565Paramus, New Jersey 07652USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706553000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"7.60","actualQuantity":"7.6","unit":"KGS","unitRateFc":"2400","totalValueFC":"18456.9","currency":"USD","unitRateINR":"201840","date":"30-Jan-2024","totalValueINR":"1533984","totalValueInUsd":"18456.9","indian_port":"Madras Air","hs_no":"29420090","bill_no":"9899383","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565Paramus, New Jersey 07652USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708885800,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"22.95","actualQuantity":"22.95","unit":"KGS","unitRateFc":"2500","totalValueFC":"58015.5","currency":"USD","unitRateINR":"209750","date":"26-Feb-2024","totalValueINR":"4813762.5","totalValueInUsd":"58015.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2305856","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"CO., LTD.29 HUAYUAN STREET LINYI COUNTY, DEZHOU, SHANDONG CHINA","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708972200,"product":"ROPIVACAINE HYDROCHLORIDE USP\/PH EUR - B.NO.RHF3D001GA - QTY800 G - AS PER INVOICE","address":"SURVEY NO. 144\/146,,","city":"TAL: SAVLI","supplier":"ASPEN API","supplierCountry":"SOUTH AFRICA","foreign_port":"CAPE TOWN","customer":"INNOXEL LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"2300","totalValueFC":"1860.5","currency":"USD","unitRateINR":"192970","date":"27-Feb-2024","totalValueINR":"154376","totalValueInUsd":"1860.5","indian_port":"Ahmedabad Air","hs_no":"29333990","bill_no":"2325643","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SOUTH AFRICA","selfForZScoreResived":"Pharma Grade","supplierPort":"CAPE TOWN","supplierAddress":"15 HAWKINS AVENUE EPPING INDUSTRIA1 7460 ZA CAPE TOWNSDNF SOUTH AFRICA","customerAddress":"SURVEY NO. 144\/146,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719426600,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"5.04","actualQuantity":"5.04","unit":"KGS","unitRateFc":"2400","totalValueFC":"12214.9","currency":"USD","unitRateINR":"202320","date":"27-Jun-2024","totalValueINR":"1019692.8","totalValueInUsd":"12214.9","indian_port":"Madras Air","hs_no":"29420090","bill_no":"4206914","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565Paramus, New Jersey 07652USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719426600,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"14.70","actualQuantity":"14.7","unit":"KGS","unitRateFc":"2400","totalValueFC":"35626.8","currency":"USD","unitRateINR":"202320","date":"27-Jun-2024","totalValueINR":"2974104","totalValueInUsd":"35626.8","indian_port":"Madras Air","hs_no":"29420090","bill_no":"4206914","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565Paramus, New Jersey 07652USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719426600,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"20.06","actualQuantity":"20.06","unit":"KGS","unitRateFc":"2400","totalValueFC":"48617.2","currency":"USD","unitRateINR":"202320","date":"27-Jun-2024","totalValueINR":"4058539.2","totalValueInUsd":"48617.2","indian_port":"Madras Air","hs_no":"29420090","bill_no":"4206914","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565Paramus, New Jersey 07652USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"4.97","actualQuantity":"4.97","unit":"KGS","unitRateFc":"2400","totalValueFC":"12056.9","currency":"USD","unitRateINR":"204720","date":"15-Nov-2024","totalValueINR":"1017458.4","totalValueInUsd":"12056.9","indian_port":"Madras Air","hs_no":"29420090","bill_no":"6693562","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565 Paramus, New Jersey 07652 USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"10.62","actualQuantity":"10.62","unit":"KGS","unitRateFc":"2400","totalValueFC":"25763.4","currency":"USD","unitRateINR":"204720","date":"15-Nov-2024","totalValueINR":"2174126.4","totalValueInUsd":"25763.4","indian_port":"Madras Air","hs_no":"29420090","bill_no":"6693562","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565 Paramus, New Jersey 07652 USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"39.38","actualQuantity":"39.38","unit":"KGS","unitRateFc":"2400","totalValueFC":"95533.2","currency":"USD","unitRateINR":"204720","date":"15-Nov-2024","totalValueINR":"8061873.6","totalValueInUsd":"95533.2","indian_port":"Madras Air","hs_no":"29420090","bill_no":"6693562","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565 Paramus, New Jersey 07652 USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"ROPIVACAINE HYDROCHLORIDE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FLAVINE","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"44.10","actualQuantity":"44.1","unit":"KGS","unitRateFc":"2400","totalValueFC":"106983.6","currency":"USD","unitRateINR":"204720","date":"15-Nov-2024","totalValueINR":"9028152","totalValueInUsd":"106983.6","indian_port":"Madras Air","hs_no":"29420090","bill_no":"6693562","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 South Paramus Road, Suite 565 Paramus, New Jersey 07652 USA US","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"}]
18-Feb-2021
30-Nov-2024
KGS
overview
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Average Price (USD/KGS)

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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Europe

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BIO Partnering at JPM
Not Confirmed

ropivakainhydroklorid, vattenfri

Brand Name : Ropivacaine Orion

Dosage Form : INFUSIONSVÄTSKA, LÖSNING

Dosage Strength : 2 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

02

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BIO Partnering at JPM
Not Confirmed

ropivakainhydroklorid, vattenfri

Brand Name : Ropivacaine Orion

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 10 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

03

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BIO Partnering at JPM
Not Confirmed

ropivakainhydroklorid, vattenfri

Brand Name : Ropivacaine Orion

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 2 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

04

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BIO Partnering at JPM
Not Confirmed

ropivakainhydroklorid, vattenfri

Brand Name : Ropivacaine Orion

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 5 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

05

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BIO Partnering at JPM
Not Confirmed

ropivakainhydroklorid, vattenfri

Brand Name : Ropivacaine Orion

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 7,5 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

06

AstraZeneca AB

United Kingdom
BIO Partnering at JPM
Not Confirmed
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AstraZeneca AB

United Kingdom
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BIO Partnering at JPM
Not Confirmed

ropivakainhydrokloridmonohydrat

Brand Name : Narop

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 7.5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

ASTRAZENECA SpA

United Kingdom
BIO Partnering at JPM
Not Confirmed
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ASTRAZENECA SpA

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Ropivacaine Hcl

Brand Name : Naropina

Dosage Form :

Dosage Strength : 5 Pockets 100 Ml 2 Mg/Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

AstraZeneca

United Kingdom
BIO Partnering at JPM
Not Confirmed
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AstraZeneca

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Ropivacaine

Brand Name : Naropin

Dosage Form : Injection fluid, resolution

Dosage Strength : 10 mg/ml

Packaging : Ampoule of plastic in sterile foil gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

AstraZeneca

United Kingdom
BIO Partnering at JPM
Not Confirmed
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AstraZeneca

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Ropivacaine

Brand Name : Naropin

Dosage Form : Injection fluid, resolution

Dosage Strength : 5 mg/ml

Packaging : Ampoule of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

ropivakainhydrokloridmonohydrat

Brand Name : Ropivacaine B. Braun

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 10 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Canada

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01

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Biotech Showcase
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging : 20ML

Approval Date :

Application Number : 2229415

Regulatory Info :

Registration Country : Canada

Aspen API Comapny Banner

02

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BIO Partnering at JPM
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging : 10ML/20ML

Approval Date :

Application Number : 2229418

Regulatory Info :

Registration Country : Canada

Aspen API Comapny Banner

03

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BIO Partnering at JPM
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION

Dosage Strength : 2MG/ML

Packaging : 100ML/20OML

Approval Date :

Application Number : 2229411

Regulatory Info :

Registration Country : Canada

Aspen API Comapny Banner

04

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : ROPIVACAINE HYDROCHLORIDE INJECTION, USP

Dosage Form : SOLUTION

Dosage Strength : 2MG/ML

Packaging : 10/20/100/200ML

Approval Date :

Application Number : 2439379

Regulatory Info :

Registration Country : Canada

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05

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : ROPIVACAINE HYDROCHLORIDE INJECTION, USP

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging : 10ML

Approval Date :

Application Number : 2439387

Regulatory Info :

Registration Country : Canada

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06

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : ROPIVACAINE HYDROCHLORIDE INJECTION, USP

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging :

Approval Date :

Application Number : 2439409

Regulatory Info :

Registration Country : Canada

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South Africa

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01

Adcock Ingram Limited

South Africa
BIO Partnering at JPM
Not Confirmed
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Adcock Ingram Limited

South Africa
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BIO Partnering at JPM
Not Confirmed

Ropivacaine Hydrochloride

Brand Name : Adco Ropivacaine 200mg/100ml

Dosage Form : INF

Dosage Strength : 200mg/100ml

Packaging : 100X5mg/100ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Ropivacaine

Brand Name : Naropin 10Ml Polyampoule

Dosage Form : INJ

Dosage Strength : 5mg/ml

Packaging : 5X1mg/ml

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Regulatory Info : Originator

Registration Country : South Africa

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Ropivacaine Hydrochloride

Brand Name : Naropin 20Mg/Ml Polyamp

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 20X5mg/ml

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ropivacaine Hydrochloride

Brand Name : Naropin 7.5mg/ml Polyamp

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 10X5mg/ml

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ropivacaine Hydrochloride

Brand Name : Naropin 10mg/ml Polyamp

Dosage Form : INJ

Dosage Strength : 10mg/ml

Packaging : 10X5mg/ml

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ropivacaine Hydrochloride

Brand Name : Naropin 2mg/ml Polybag

Dosage Form : INF

Dosage Strength : 2mg/ml

Packaging : 100X5mg/ml

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Regulatory Info : Originator

Registration Country : South Africa

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Ropivacaine Hydrochloride

Brand Name : Naropin 2mg/ml Polybag

Dosage Form : INF

Dosage Strength : 2mg/ml

Packaging : 200X5mg/ml

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Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ethypharm

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Ethypharm

France
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Ropivacaine Hydrochloride

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Pharmathen SA

Greece
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Pharmathen SA

Greece
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Pharmathen SA

Greece
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Regulatory Info : EU Approved

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Pharmathen SA

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Pharmathen SA

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Ropivacaine Hydrochloride

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Pharmathen SA

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Pharmathen SA

Greece
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Ropivacaine Hydrochloride

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Dosage Strength : 7.5MG/ML

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Regulatory Info : EU Approved

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Pharmathen SA

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Pharmathen SA

Greece
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Ropivacaine Hydrochloride

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Dosage Strength : 10MG/ML

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Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

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Pharmathen SA

Greece
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Ropivacaine Hydrochloride

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Demo S.A.

Greece
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Ropivacaine

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Regulatory Info : Generic

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Ropivacaine

Dosage : SOLUTION FOR INJECTION...

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Hanlim Pharmaceutical

South Korea
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South Korea
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Ropivacaine Hcl

Brand Name : ROPIVA

Dosage Form : INJECTION

Dosage Strength : 40MG

Packaging : 5A, 2

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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Hanlim Pharmaceutical

South Korea
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Ropivacaine Hcl

Dosage : INJECTION

Dosage Strength : 40MG

Brand Name : ROPIVA

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Application Number :

Registration Country : South Korea

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Hanlim Pharmaceutical

South Korea
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Ropivacaine Hcl

Brand Name : ROPIVA

Dosage Form : INJECTION

Dosage Strength : 150MG

Packaging : 5A, 2

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Regulatory Info : Generic

Registration Country : South Korea

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Hanlim Pharmaceutical

South Korea
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South Korea
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Ropivacaine Hcl

Dosage : INJECTION

Dosage Strength : 150MG

Brand Name : ROPIVA

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Registration Country : South Korea

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Pluviaendo

Turkey
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Turkey
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Ropivacaine Hydrochloride

Brand Name :

Dosage Form : Ampoule

Dosage Strength : 50MG/10ML

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Registration Country : Turkey

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Pluviaendo

Turkey
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Dosage : Ampoule

Dosage Strength : 50MG/10ML

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Registration Country : Turkey

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

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 100MG/20ML (5MG...DOSAGE - SOLUTION;INJECTION - 100MG/20ML (5MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 150MG/30ML (5MG...DOSAGE - SOLUTION;INJECTION - 150MG/30ML (5MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 150MG/20ML (7.5...DOSAGE - SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 1GM/200ML (5MG/...DOSAGE - SOLUTION;INJECTION - 1GM/200ML (5MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 200MG/20ML (10M...DOSAGE - SOLUTION;INJECTION - 200MG/20ML (10MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 200MG/100ML (2M...DOSAGE - SOLUTION;INJECTION - 200MG/100ML (2MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 20MG/10ML (2MG/...DOSAGE - SOLUTION;INJECTION - 20MG/10ML (2MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 400MG/200ML (2M...DOSAGE - SOLUTION;INJECTION - 400MG/200ML (2MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 40MG/20ML (2MG/...DOSAGE - SOLUTION;INJECTION - 40MG/20ML (2MG/ML)

USFDA APPLICATION NUMBER - 20533

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DOSAGE - SOLUTION;INJECTION - 500MG/100ML (5M...DOSAGE - SOLUTION;INJECTION - 500MG/100ML (5MG/ML)

USFDA APPLICATION NUMBER - 20533

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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

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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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ABOUT THIS PAGE

Ropivacaine Hydrochloride Manufacturers

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.

Ropivacaine Hydrochloride Suppliers

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.

Ropivacaine Hydrochloride USDMF

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.

Ropivacaine Hydrochloride JDMF

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.

Ropivacaine Hydrochloride KDMF

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.

Ropivacaine Hydrochloride CEP

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.

Ropivacaine Hydrochloride WC

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.

Ropivacaine Hydrochloride NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Ropivacaine Hydrochloride CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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