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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
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
Molecular Weight | 324.9 g/mol |
---|---|
Molecular Formula | C18H29ClN2O |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 5 |
Exact Mass | 324.1968412 g/mol |
Monoisotopic Mass | 324.1968412 g/mol |
Topological Polar Surface Area | 32.3 Ų |
Heavy Atom Count | 22 |
Formal Charge | 0 |
Complexity | 321 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 6 | |
---|---|
Drug Name | Bupivacaine hydrochloride |
PubMed Health | Bupivacaine/Epinephrine (Injection) |
Drug Classes | Anesthetic, Amino Amide Combination, Anesthetic, Local |
Drug Label | Sensorcaine (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 Ingredient | Bupivacaine hydrochloride |
Dosage Form | Injectable |
Route | injection; Spinal; Injection |
Strength | 0.5%; 0.75%; 0.25% |
Market Status | Prescription |
Company | Sagent Agila; Hospira |
2 of 6 | |
---|---|
Drug Name | Marcaine |
PubMed Health | Bupivacaine (Injection) |
Drug Classes | Anesthetic, Local |
Drug Label | MarcaineBupivacaine 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 Ingredient | Bupivacaine hydrochloride |
Dosage Form | Injectable |
Route | Spinal |
Strength | 0.75% |
Market Status | Prescription |
Company | Hospira |
3 of 6 | |
---|---|
Drug Name | Sensorcaine |
Drug Label | Sensorcaine (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 Ingredient | Bupivacaine hydrochloride; epinephrine bitartrate |
Dosage Form | Injectable |
Route | Spinal; Injection |
Strength | 0.5%; 0.0091mg/ml; 0.75%; 0.25% |
Market Status | Prescription |
Company | Fresenius Kabi Usa |
4 of 6 | |
---|---|
Drug Name | Bupivacaine hydrochloride |
PubMed Health | Bupivacaine/Epinephrine (Injection) |
Drug Classes | Anesthetic, Amino Amide Combination, Anesthetic, Local |
Drug Label | Sensorcaine (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 Ingredient | Bupivacaine hydrochloride |
Dosage Form | Injectable |
Route | injection; Spinal; Injection |
Strength | 0.5%; 0.75%; 0.25% |
Market Status | Prescription |
Company | Sagent Agila; Hospira |
5 of 6 | |
---|---|
Drug Name | Marcaine |
PubMed Health | Bupivacaine (Injection) |
Drug Classes | Anesthetic, Local |
Drug Label | MarcaineBupivacaine 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 Ingredient | Bupivacaine hydrochloride |
Dosage Form | Injectable |
Route | Spinal |
Strength | 0.75% |
Market Status | Prescription |
Company | Hospira |
6 of 6 | |
---|---|
Drug Name | Sensorcaine |
Drug Label | Sensorcaine (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 Ingredient | Bupivacaine hydrochloride; epinephrine bitartrate |
Dosage Form | Injectable |
Route | Spinal; Injection |
Strength | 0.5%; 0.0091mg/ml; 0.75%; 0.25% |
Market Status | Prescription |
Company | Fresenius Kabi Usa |
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.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-29
Pay. Date : 2013-01-07
DMF Number : 22228
Submission : 2008-11-24
Status : Active
Type : II
Certificate Number : R1-CEP 2010-277 - Rev 03
Issue Date : 2022-01-24
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 52932-0729
Start Marketing Date : 2009-09-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2024-08-02
Valid Till : 2027-08-01
Written Confirmation Number : SD240040
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6495
Submission : 1986-05-23
Status : Active
Type : II
Certificate Number : R1-CEP 2001-013 - Rev 02
Issue Date : 2015-02-09
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 12660-0391
Start Marketing Date : 1979-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 2911
Submission : 1977-04-12
Status : Active
Type : II
Certificate Number : R1-CEP 2004-043 - Rev 04
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 17381-074
Start Marketing Date : 2010-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-01
Pay. Date : 2014-04-25
DMF Number : 20959
Submission : 2007-10-18
Status : Active
Type : II
Date of Issue : 2019-12-03
Valid Till : 2022-07-21
Written Confirmation Number : WC-0135A
Address of the Firm :
NDC Package Code : 61876-0726
Start Marketing Date : 2016-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-18
Pay. Date : 2019-10-15
DMF Number : 5984
Submission : 1985-08-27
Status : Active
Type : II
Certificate Number : R1-CEP 2011-254 - Rev 00
Issue Date : 2019-01-31
Type : Chemical
Substance Number : 541
Status : Valid
Registration Number : 218MF10875
Registrant's Address : SE-691 85 Karlskoga, SWEDEN
Initial Date of Registration : 2006-11-10
Latest Date of Registration : --
NDC Package Code : 12651-111
Start Marketing Date : 2016-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2022-12-15
Registration Number : 20221215-210-J-1423
Manufacturer Name : Cambrex Karlskoga AB
Manufacturer Address : SE-691 85 Karlskoga, Sweden
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-31
Pay. Date : 2016-05-04
DMF Number : 21196
Submission : 2007-12-20
Status : Active
Type : II
Certificate Number : CEP 2003-173 - Rev 04
Issue Date : 2023-10-04
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 46014-1113
Start Marketing Date : 2007-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26649
Submission : 2012-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-29
Pay. Date : 2013-01-07
DMF Number : 22228
Submission : 2008-11-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-18
Pay. Date : 2019-10-15
DMF Number : 5984
Submission : 1985-08-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2014-04-25
DMF Number : 20959
Submission : 2007-10-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-31
Pay. Date : 2016-05-04
DMF Number : 21196
Submission : 2007-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26649
Submission : 2012-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 2911
Submission : 1977-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6495
Submission : 1986-05-23
Status : Active
Type : II
Certificate Number : R1-CEP 2010-277 - Rev 03
Status : Valid
Issue Date : 2022-01-24
Type : Chemical
Substance Number : 541
Certificate Number : R1-CEP 2011-254 - Rev 00
Status : Valid
Issue Date : 2019-01-31
Type : Chemical
Substance Number : 541
Certificate Number : R1-CEP 2009-038 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2017-07-28
Type : Chemical
Substance Number : 541
Certificate Number : CEP 2003-173 - Rev 04
Status : Valid
Issue Date : 2023-10-04
Type : Chemical
Substance Number : 541
Certificate Number : R1-CEP 2007-116 - Rev 02
Status : Valid
Issue Date : 2020-09-25
Type : Chemical
Substance Number : 541
Certificate Number : R1-CEP 2004-043 - Rev 04
Status : Valid
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 541
Certificate Number : R1-CEP 2001-013 - Rev 02
Status : Valid
Issue Date : 2015-02-09
Type : Chemical
Substance Number : 541
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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RLD : No
TE Code :
Brand Name : BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.5%
Approval Date : 2002-01-09
Application Number : 76012
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.75%
Approval Date : 2002-01-09
Application Number : 76012
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code : AP
Brand Name : SENSORCAINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.25%
Approval Date : 1982-01-01
Application Number : 18304
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : SENSORCAINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.5%
Approval Date : 1982-01-01
Application Number : 18304
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code : AP
Brand Name : SENSORCAINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.5%
Approval Date : 1986-05-21
Application Number : 70553
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Brand Name : SENSORCAINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.25%;0.0091MG/ML
Approval Date : 1987-10-13
Application Number : 70966
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Brand Name : SENSORCAINE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.25%;0.0091MG/ML
Approval Date : 1987-10-13
Application Number : 70967
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.25%
Approval Date : 2021-02-11
Application Number : 204842
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.5%
Approval Date : 1982-01-01
Application Number : 16964
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : MARCAINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 0.5%
Approval Date : 1982-01-01
Application Number : 16964
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : Brazil
Bupivacaine Hydrochloride; Anhydrous Dextrose
Brand Name : NEOCAINA
Dosage Form : INJECTION
Dosage Strength :
Packaging : 40 AMPS X 4 ML (Sterile Pack)
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Brazil
Packaging : 40 AMPS X 4 ML (Sterile Pack)
Regulatory Info : Generic
Bupivacaine Hydrochloride; Anhydrous Dextrose
Dosage : INJECTION
Dosage Strength :
Brand Name : NEOCAINA
Approval Date :
Application Number :
Registration Country : Brazil
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 2.5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 2.5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 2.5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 2.5MG; 5MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 2.5MG; 5MCG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : Bupivacaine HCl
Dosage Form : INJECTION
Dosage Strength : 100MG/20ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging :
Regulatory Info : Generic
Dosage : INJECTION
Dosage Strength : 100MG/20ML
Brand Name : Bupivacaine HCl
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : Bupivacaine HCl
Dosage Form : INJECTION
Dosage Strength : 21.2MG/4ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging :
Regulatory Info : Generic
Dosage : INJECTION
Dosage Strength : 21.2MG/4ML
Brand Name : Bupivacaine HCl
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Ampoule
Dosage Strength : 20MG/4ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage : Ampoule
Dosage Strength : 20MG/4ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
DRUG PRODUCT COMPOSITIONS
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Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Bupivacaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupivacaine Hydrochloride, including repackagers and relabelers. The FDA regulates Bupivacaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupivacaine 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 Bupivacaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bupivacaine Hydrochloride supplier is an individual or a company that provides Bupivacaine Hydrochloride active pharmaceutical ingredient (API) or Bupivacaine Hydrochloride finished formulations upon request. The Bupivacaine Hydrochloride suppliers may include Bupivacaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Bupivacaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bupivacaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Bupivacaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Bupivacaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Bupivacaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bupivacaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Bupivacaine Hydrochloride USDMF includes data on Bupivacaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bupivacaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bupivacaine Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Bupivacaine Hydrochloride Drug Master File in Japan (Bupivacaine Hydrochloride JDMF) empowers Bupivacaine 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 Bupivacaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bupivacaine 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 Bupivacaine Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bupivacaine Hydrochloride Drug Master File in Korea (Bupivacaine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bupivacaine Hydrochloride. The MFDS reviews the Bupivacaine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Bupivacaine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bupivacaine 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 Bupivacaine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
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A Bupivacaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Bupivacaine Hydrochloride Certificate of Suitability (COS). The purpose of a Bupivacaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bupivacaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bupivacaine Hydrochloride to their clients by showing that a Bupivacaine Hydrochloride CEP has been issued for it. The manufacturer submits a Bupivacaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bupivacaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Bupivacaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bupivacaine Hydrochloride DMF.
A Bupivacaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bupivacaine 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 Bupivacaine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Bupivacaine Hydrochloride written confirmation (Bupivacaine Hydrochloride WC) is an official document issued by a regulatory agency to a Bupivacaine Hydrochloride manufacturer, verifying that the manufacturing facility of a Bupivacaine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bupivacaine Hydrochloride APIs or Bupivacaine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Bupivacaine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Bupivacaine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Bupivacaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bupivacaine Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Bupivacaine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Bupivacaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bupivacaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bupivacaine Hydrochloride suppliers with NDC on PharmaCompass.
Bupivacaine 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 Bupivacaine 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 Bupivacaine Hydrochloride GMP manufacturer or Bupivacaine Hydrochloride GMP API supplier for your needs.
A Bupivacaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Bupivacaine Hydrochloride's compliance with Bupivacaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Bupivacaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Bupivacaine 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.
Bupivacaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Bupivacaine Hydrochloride EP), Bupivacaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bupivacaine Hydrochloride USP).
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