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Chemistry

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Also known as: Bupivacaine hcl, 18010-40-7, 14252-80-3, Carbostesin, Vivacaine, Sensorcaine
Molecular Formula
C18H29ClN2O
Molecular Weight
324.9  g/mol
InChI Key
SIEYLFHKZGLBNX-UHFFFAOYSA-N
FDA UNII
AKA908P8J1

Bupivacaine Hydrochloride
A widely used local anesthetic agent.
1 2D Structure

Bupivacaine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide;hydrochloride
2.1.2 InChI
InChI=1S/C18H28N2O.ClH/c1-4-5-12-20-13-7-6-11-16(20)18(21)19-17-14(2)9-8-10-15(17)3;/h8-10,16H,4-7,11-13H2,1-3H3,(H,19,21);1H
2.1.3 InChI Key
SIEYLFHKZGLBNX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCN1CCCCC1C(=O)NC2=C(C=CC=C2C)C.Cl
2.2 Other Identifiers
2.2.1 UNII
AKA908P8J1
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-butyl-n-(2,6-dimethylphenyl)-2-piperidinecarboxamide

2. Bupivacain Janapharm

3. Bupivacain Rpr

4. Bupivacain-rpr

5. Bupivacaina Braun

6. Bupivacaine

7. Bupivacaine Anhydrous

8. Bupivacaine Carbonate

9. Bupivacaine Monohydrochloride, Monohydrate

10. Buvacaina

11. Carbostesin

12. Dolanaest

13. Marcain

14. Marcaine

15. Sensorcaine

16. Svedocain Sin Vasoconstr

2.3.2 Depositor-Supplied Synonyms

1. Bupivacaine Hcl

2. 18010-40-7

3. 14252-80-3

4. Carbostesin

5. Vivacaine

6. Sensorcaine

7. Bupivacaine (hydrochloride)

8. 1-butyl-n-(2,6-dimethylphenyl)piperidine-2-carboxamide Hydrochloride

9. Marcain

10. Ah-2250

11. Bupivacaine Hydrochloride Anhydrous

12. Lac-43

13. Nsc-758631

14. 1-butyl-n-(2,6-dimethylphenyl)piperidine-2-carboxamide;hydrochloride

15. 2-piperidinecarboxamide, 1-butyl-n-(2,6-dimethylphenyl)-, Monohydrochloride

16. Win 11,318

17. Aka908p8j1

18. Chebi:31322

19. 1-butyl-n-(2,6-dimethylphenyl)-2-piperidinecarboxamide Monohydrochloride

20. Bloqueina

21. Xaracoll

22. 2-piperidinecarboxamide, 1-butyl-n-(2,6-dimethylphenyl)-, Hydrochloride (1:1)

23. (s)-bupivacaine Hydrochloride

24. Bicain

25. Marcaine Spinal

26. Smr000058218

27. (+-)-bupivacaine Hydrochloride

28. Bupivacaine Hydrochloride [jan]

29. Mnarcaine Hydrochloride

30. Einecs 241-917-8

31. Bupivacaine Hydrochloride Kit

32. Unii-aka908p8j1

33. Lac 43

34. Sr-05000001874

35. 1-butyl-n-(2,6-dimethylphenyl)-2-piperidinecarboxamide

36. Levobupivacaine Hydrochloride (anhydrous)

37. 2',6'-pipecoloxylidide, 1-butyl-, Hydrochloride

38. Sky 0302

39. Prestwick_894

40. 2',6'-pipecoloxylidide, 1-butyl-, Monohydrochloride

41. Ah 2250

42. Marcaine Hydrochloride Preservation Free

43. Bupivacain Hydrochloride

44. Bupivacaine Hydrochloride Preservation Free

45. Bupivacaini Hydrochloridum

46. Bupivacaine Hydrochloride Rs

47. Bupivacaine Monohydrochloride

48. Win 11318 Hcl

49. Schembl34374

50. Mls001361336

51. Mls002154259

52. Spectrum1503818

53. Bupivacaine-[d9] Hydrochloride

54. Chembl1200396

55. Dtxsid0030877

56. Chebi:77441

57. Hy-b0405a

58. Bupivacaine Hydrochloride(marcain)

59. Hms1568n12

60. Hms1922i12

61. Pharmakon1600-01503818

62. Bupivacaine Hydrochloride (marcain)

63. Act04725

64. Bcp22697

65. Bcp22708

66. Bupivacaine Hydrochloride (anhydrous)

67. Ccg-39367

68. Mfcd00078956

69. Nsc119660

70. Nsc758631

71. S2454

72. Bupivacaine Hydrochloride [mi]

73. Akos015889322

74. Bcp9000461

75. Fd-0235

76. Nsc 758631

77. Nsc-119660

78. Ncgc00095072-01

79. Ncgc00095072-02

80. Anhydrous Bupivacaine Hydrochloride

81. Bupivacaine Hydrochloride [who-dd]

82. Bupivacaine Hydrochloride, Anhydrous

83. B3925

84. Ft-0607564

85. Ft-0623287

86. Ft-0658830

87. Ft-0663897

88. Ft-0663899

89. Sw197015-3

90. 52b803

91. Bupivacaine Hydrochloride [usp Impurity]

92. J-011502

93. Q-100158

94. Sr-05000001874-3

95. Q27888209

96. 1-butyl-2-piperidylformo-2',6'-xylidide Hydrochloride

97. 2-piperidinecarboxamide,6-dimethylphenyl)-, Hydrochloride

98. 1-butyl-2-[(2,6-dimethylphenyl)carbamoyl]piperidinium Chloride

99. (+/-)-1-butyl-2',6'-pipecoloxylidide Monohydrochloride

100. Rac-1-butyl-2-[(2,6-dimethylphenyl)carbamoyl]piperidinium Chloride

101. Rac-1-butyl-n-(2,6-dimethylphenyl)piperidine-2-carboxamide Hydrochloride

102. 15233-43-9

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 324.9 g/mol
Molecular Formula C18H29ClN2O
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count5
Exact Mass324.1968412 g/mol
Monoisotopic Mass324.1968412 g/mol
Topological Polar Surface Area32.3 Ų
Heavy Atom Count22
Formal Charge0
Complexity321
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameBupivacaine hydrochloride
PubMed HealthBupivacaine/Epinephrine (Injection)
Drug ClassesAnesthetic, Amino Amide Combination, Anesthetic, Local
Drug LabelSensorcaine (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for spe...
Active IngredientBupivacaine hydrochloride
Dosage FormInjectable
Routeinjection; Spinal; Injection
Strength0.5%; 0.75%; 0.25%
Market StatusPrescription
CompanySagent Agila; Hospira

2 of 6  
Drug NameMarcaine
PubMed HealthBupivacaine (Injection)
Drug ClassesAnesthetic, Local
Drug LabelMarcaineBupivacaine Hydrochloride Injection, USPMarcaineWith Epinephrine 1:200,000 (as bitartrate)Bupivacaine Hydrochloride and Epinephrine Injection, USP Rx onlyBupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylpheny...
Active IngredientBupivacaine hydrochloride
Dosage FormInjectable
RouteSpinal
Strength0.75%
Market StatusPrescription
CompanyHospira

3 of 6  
Drug NameSensorcaine
Drug LabelSensorcaine (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for spe...
Active IngredientBupivacaine hydrochloride; epinephrine bitartrate
Dosage FormInjectable
RouteSpinal; Injection
Strength0.5%; 0.0091mg/ml; 0.75%; 0.25%
Market StatusPrescription
CompanyFresenius Kabi Usa

4 of 6  
Drug NameBupivacaine hydrochloride
PubMed HealthBupivacaine/Epinephrine (Injection)
Drug ClassesAnesthetic, Amino Amide Combination, Anesthetic, Local
Drug LabelSensorcaine (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for spe...
Active IngredientBupivacaine hydrochloride
Dosage FormInjectable
Routeinjection; Spinal; Injection
Strength0.5%; 0.75%; 0.25%
Market StatusPrescription
CompanySagent Agila; Hospira

5 of 6  
Drug NameMarcaine
PubMed HealthBupivacaine (Injection)
Drug ClassesAnesthetic, Local
Drug LabelMarcaineBupivacaine Hydrochloride Injection, USPMarcaineWith Epinephrine 1:200,000 (as bitartrate)Bupivacaine Hydrochloride and Epinephrine Injection, USP Rx onlyBupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylpheny...
Active IngredientBupivacaine hydrochloride
Dosage FormInjectable
RouteSpinal
Strength0.75%
Market StatusPrescription
CompanyHospira

6 of 6  
Drug NameSensorcaine
Drug LabelSensorcaine (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for spe...
Active IngredientBupivacaine hydrochloride; epinephrine bitartrate
Dosage FormInjectable
RouteSpinal; Injection
Strength0.5%; 0.0091mg/ml; 0.75%; 0.25%
Market StatusPrescription
CompanyFresenius Kabi Usa

5 Pharmacology and Biochemistry
5.1 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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Amides [CS]; Local Anesthesia [PE]; Amide Local Anesthetic [EPC]

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CORPORATION","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"535","totalValueFC":"13534.8","currency":"USD","unitRateINR":"45127.2","date":"09-May-2024","totalValueINR":"1128181","totalValueInUsd":"13534.8","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"3403654","productDescription":"API","marketType":"","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"BUPIVACAINE HYDROCHLORIDE - IUPAC NAME 1-BUTYL-N-(2,6-DIMETHYLPHENYL) PIPERDINE-2-CARBOXAMIDE HYDROCHLORIDE CAS NO733","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"CHEMESS DWC LLC","supplierCountry":"ITALY","foreign_port":"FLORENCE","customer":"J.B.CHEMICALS & 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PHARMACEUTICAL","customerCountry":"INDIA","quantity":"27.00","actualQuantity":"27","unit":"KGS","unitRateFc":"920","totalValueFC":"25084.2","currency":"USD","unitRateINR":"77556","date":"18-Jun-2024","totalValueINR":"2094012","totalValueInUsd":"25084.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29333990","bill_no":"1004315","productDescription":"API","marketType":"","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POLIGONO RUBI SUR CESAR MARTINELL I BRUNT, 12A - 08191 RUBI BARCELON A SPAIN","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"BUPIVACAINE HYDROCHLORIDE","address":"SHANKAR TOWERS PLOT NO. A30,A.I.E","city":"HYDERABAD,TELANGANA","supplier":"CAMBREX CORPORATION","supplierCountry":"SWEDEN","foreign_port":"GOTHENBURG","customer":"ANTHEA PHARMA PVT LTD","customerCountry":"INDIA","quantity":"3.10","actualQuantity":"3.1","unit":"KGS","unitRateFc":"750","totalValueFC":"2347.2","currency":"USD","unitRateINR":"63450","date":"24-Sep-2024","totalValueINR":"196695","totalValueInUsd":"2347.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5763824","productDescription":"API","marketType":"","country":"SWEDEN","selfForZScoreResived":"Pharma Grade","supplierPort":"GOTHENBURG","supplierAddress":"SE-691 85 KARLSKOGA SWEDEN SDNF SE","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"BUPIVACAINE HYDROCHLORIDE CODE.NO.75630 NDC: 52932-0729 BATCH NO: 88","address":"CLARIS CORPORATE HEAD QUARTERS,","city":"ELLISBRIDGE,AHMEDABD,GUJARAT,INDIA","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"BAXTER HEALTHCARE CORPORATION","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"535","totalValueFC":"13506.1","currency":"USD","unitRateINR":"45394.8","date":"14-Oct-2024","totalValueINR":"1134868.75","totalValueInUsd":"13506.1","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"6101040","productDescription":"API","marketType":"","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/. CESAR MARTINELI I BRUNET 12A C\/ ROMA, 8-12 08191-RUBI-BCN 08191 RUB I Barcelona, SPAIN SPAIN","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"BUPIVACAINE HYDROCHLORIDE CODE.NO.75630 NDC: 52932-0729 BATCH NO: 89","address":"CLARIS CORPORATE HEAD QUARTERS,","city":"ELLISBRIDGE,AHMEDABD,GUJARAT,INDIA","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"BAXTER HEALTHCARE CORPORATION","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"535","totalValueFC":"40518.2","currency":"USD","unitRateINR":"45394.8","date":"14-Oct-2024","totalValueINR":"3404606.25","totalValueInUsd":"40518.2","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"6102540","productDescription":"API","marketType":"","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/. CESAR MARTINELI I BRUNET 12A C\/ ROMA, 8-12 08191-RUBI-BCN 08191 RUB I Barcelona, SPAIN SPAIN","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"BUPIVACAINE HYDROCHLORIDE USP","address":"HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"CAMBREX CORPORATION","supplierCountry":"SWEDEN","foreign_port":"STOCKHOLM - ARLANDA","customer":"ASPIRO PHARMA","customerCountry":"INDIA","quantity":"65.50","actualQuantity":"65.5","unit":"KGS","unitRateFc":"942","totalValueFC":"62111.8","currency":"USD","unitRateINR":"80022.9","date":"02-Nov-2024","totalValueINR":"5241499.95","totalValueInUsd":"62111.8","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"6462355","productDescription":"API","marketType":"","country":"SWEDEN","selfForZScoreResived":"Pharma Grade","supplierPort":"STOCKHOLM - ARLANDA","supplierAddress":"BJOERKBORNS INDUSTRIOMRADDE KARLSKO GA - 69185, , Sweden SDNF Sweden","customerAddress":"HETERO HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"BUPIVACAINE HYDROCHLORIDE","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"1400","totalValueFC":"3060.9","currency":"EUR","unitRateINR":"129150","date":"14-Nov-2024","totalValueINR":"258300","totalValueInUsd":"3060.9","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"6670655","productDescription":"API","marketType":"","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CESAR MARTINELL I BRUNET 12 A 08191 RUBI SPAIN BARCELONA, , Spain SDNF Spain","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733077800,"product":"BUPIVACAINE HYDROCHLORIDE","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"JIANGXI CHIBANG PHARMACEUTICAL CO.,LTD","supplierCountry":"SWEDEN","foreign_port":"ARLANDA APT\/STOCKHOLM, C","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"612.00","actualQuantity":"612","unit":"KGS","unitRateFc":"800.1","totalValueFC":"491834.6","currency":"USD","unitRateINR":"68285.4","date":"02-Dec-2024","totalValueINR":"41790689","totalValueInUsd":"491834.6","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29333990","bill_no":"6994525","productDescription":"API","marketType":"","country":"SWEDEN","selfForZScoreResived":"Pharma Grade","supplierPort":"ARLANDA APT\/STOCKHOLM, C","supplierAddress":"N\/A","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"}]
22-Jan-2021
18-Feb-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 0.25%

USFDA APPLICATION NUMBER - 16964

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DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091MG/ML

USFDA APPLICATION NUMBER - 16964

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DOSAGE - INJECTABLE;INJECTION - 0.5%

USFDA APPLICATION NUMBER - 16964

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DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML

USFDA APPLICATION NUMBER - 16964

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DOSAGE - INJECTABLE;INJECTION - 0.75%

USFDA APPLICATION NUMBER - 16964

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DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML

USFDA APPLICATION NUMBER - 16964

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DOSAGE - INJECTABLE;INJECTION - 0.25%

USFDA APPLICATION NUMBER - 18304

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DOSAGE - INJECTABLE;INJECTION - 0.5%

USFDA APPLICATION NUMBER - 18304

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DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML

USFDA APPLICATION NUMBER - 18304

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DOSAGE - INJECTABLE;INJECTION - 0.75%

USFDA APPLICATION NUMBER - 18304

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DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML

USFDA APPLICATION NUMBER - 18304

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DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML

USFDA APPLICATION NUMBER - 22046

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ABOUT THIS PAGE

Looking for 14252-80-3 / Bupivacaine Hydrochloride API manufacturers, exporters & distributors?

Bupivacaine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bupivacaine 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 Bupivacaine Hydrochloride manufacturer or Bupivacaine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bupivacaine Hydrochloride manufacturer or Bupivacaine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Bupivacaine Hydrochloride API Price utilized in the formulation of products. Bupivacaine Hydrochloride API Price is not always fixed or binding as the Bupivacaine Hydrochloride Price is obtained through a variety of data sources. The Bupivacaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Bupivacaine Hydrochloride

Synonyms

Bupivacaine hcl, 18010-40-7, 14252-80-3, Carbostesin, Vivacaine, Sensorcaine

Cas Number

14252-80-3

Unique Ingredient Identifier (UNII)

AKA908P8J1

About Bupivacaine Hydrochloride

A widely used local anesthetic agent.

Buvacaina Manufacturers

A Buvacaina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buvacaina, including repackagers and relabelers. The FDA regulates Buvacaina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buvacaina 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 Buvacaina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Buvacaina Suppliers

A Buvacaina supplier is an individual or a company that provides Buvacaina active pharmaceutical ingredient (API) or Buvacaina finished formulations upon request. The Buvacaina suppliers may include Buvacaina API manufacturers, exporters, distributors and traders.

click here to find a list of Buvacaina suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Buvacaina USDMF

A Buvacaina DMF (Drug Master File) is a document detailing the whole manufacturing process of Buvacaina active pharmaceutical ingredient (API) in detail. Different forms of Buvacaina DMFs exist exist since differing nations have different regulations, such as Buvacaina USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Buvacaina DMF submitted to regulatory agencies in the US is known as a USDMF. Buvacaina USDMF includes data on Buvacaina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Buvacaina USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Buvacaina suppliers with USDMF on PharmaCompass.

Buvacaina 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 Buvacaina Drug Master File in Japan (Buvacaina JDMF) empowers Buvacaina 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 Buvacaina JDMF during the approval evaluation for pharmaceutical products. At the time of Buvacaina 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 Buvacaina suppliers with JDMF on PharmaCompass.

Buvacaina KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Buvacaina Drug Master File in Korea (Buvacaina KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Buvacaina. The MFDS reviews the Buvacaina KDMF as part of the drug registration process and uses the information provided in the Buvacaina KDMF to evaluate the safety and efficacy of the drug.

After submitting a Buvacaina 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 Buvacaina API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Buvacaina suppliers with KDMF on PharmaCompass.

Buvacaina CEP

A Buvacaina CEP of the European Pharmacopoeia monograph is often referred to as a Buvacaina Certificate of Suitability (COS). The purpose of a Buvacaina CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buvacaina EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buvacaina to their clients by showing that a Buvacaina CEP has been issued for it. The manufacturer submits a Buvacaina CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buvacaina CEP holder for the record. Additionally, the data presented in the Buvacaina CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buvacaina DMF.

A Buvacaina CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buvacaina 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 Buvacaina suppliers with CEP (COS) on PharmaCompass.

Buvacaina WC

A Buvacaina written confirmation (Buvacaina WC) is an official document issued by a regulatory agency to a Buvacaina manufacturer, verifying that the manufacturing facility of a Buvacaina active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Buvacaina APIs or Buvacaina finished pharmaceutical products to another nation, regulatory agencies frequently require a Buvacaina WC (written confirmation) as part of the regulatory process.

click here to find a list of Buvacaina suppliers with Written Confirmation (WC) on PharmaCompass.

Buvacaina 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 Buvacaina as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Buvacaina 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 Buvacaina 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 Buvacaina and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Buvacaina NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Buvacaina suppliers with NDC on PharmaCompass.

Buvacaina GMP

Buvacaina 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 Buvacaina 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 Buvacaina GMP manufacturer or Buvacaina GMP API supplier for your needs.

Buvacaina CoA

A Buvacaina CoA (Certificate of Analysis) is a formal document that attests to Buvacaina's compliance with Buvacaina specifications and serves as a tool for batch-level quality control.

Buvacaina CoA mostly includes findings from lab analyses of a specific batch. For each Buvacaina 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.

Buvacaina may be tested according to a variety of international standards, such as European Pharmacopoeia (Buvacaina EP), Buvacaina JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Buvacaina 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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