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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.)

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Details:
Bupivacaine is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Pain, Postoperative.
Lead Product(s): Bupivacaine,Bupivacaine Hydrochloride
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Pacira BioSciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 08, 2025

Lead Product(s) : Bupivacaine,Bupivacaine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Pacira BioSciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy of EXPAREL vs. Bupivacaine
Details : Bupivacaine is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Pain, Postoperative.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 08, 2025

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F14 (celecoxib) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.
Lead Product(s): Celecoxib,Paracetamol,Bupivacaine Hydrochloride
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 30, 2023

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Lead Product(s) : Celecoxib,Paracetamol,Bupivacaine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : F14 (celecoxib) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 30, 2023

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GTX-101 is a novel formulation of bupivacaine hydrochloride for topical administration via a bio-adhesive, film-forming polymer, for relief of pain associated with Postherpetic Neuralgia, a neuropathic pain caused by nerve damage from the varicella zoster virus (shingles).
Lead Product(s): Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 22, 2022

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Lead Product(s) : Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : GTX-101 is a novel formulation of bupivacaine hydrochloride for topical administration via a bio-adhesive, film-forming polymer, for relief of pain associated with Postherpetic Neuralgia, a neuropathic pain caused by nerve damage from the varicella zoste...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 22, 2022

Details:
F14 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pain, Postoperative.
Lead Product(s): F14,Bupivacaine Hydrochloride,Paracetamol,Methocarbamol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Allucent
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 03, 2022

Lead Product(s) : F14,Bupivacaine Hydrochloride,Paracetamol,Methocarbamol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Allucent
Deal Size : Inapplicable
Deal Type : Inapplicable
A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
Details : F14 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pain, Postoperative.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 03, 2022

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Details:
GTX-101 (bupivacaine hydrochloride) topical administration via bio-adhesive, film-forming polymer, for relief of pain associated with PHN, a persistent and often debilitating neuropathic pain caused by nerve damage from shingles, which may persist for months and even years.
Lead Product(s): Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2022

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Lead Product(s) : Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : GTX-101 (bupivacaine hydrochloride) topical administration via bio-adhesive, film-forming polymer, for relief of pain associated with PHN, a persistent and often debilitating neuropathic pain caused by nerve damage from shingles, which may persist for mo...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 27, 2022

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Details:
POSIMIR® (bupivacaine solution) for infiltration use reduced mean pain over 72 hours after arthroscopic subacromial decompression surgery compared with vehicle control and improved several measures of postoperative opioid use.
Lead Product(s): Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area: Neurology Brand Name: Xaracoll
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 06, 2022

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Lead Product(s) : Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : POSIMIR® (bupivacaine solution) for infiltration use reduced mean pain over 72 hours after arthroscopic subacromial decompression surgery compared with vehicle control and improved several measures of postoperative opioid use.
Product Name : Xaracoll
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 06, 2022

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Details:
XARACOLL (Bupivacaine HCl), an innovative collagen drug-device implant, 300mg dose cohort experienced less pain and, was generally well tolerated with an adverse event profile comparable to the current prescribing information.
Lead Product(s): Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area: Neurology Brand Name: Xaracoll
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 02, 2022

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Lead Product(s) : Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : XARACOLL (Bupivacaine HCl), an innovative collagen drug-device implant, 300mg dose cohort experienced less pain and, was generally well tolerated with an adverse event profile comparable to the current prescribing information.
Product Name : Xaracoll
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 02, 2022

Details:
Tylenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pain, Postoperative.
Lead Product(s): Paracetamol,Methocarbamol,Tramadol Hydrochloride,Bupivacaine Hydrochloride,Epinephrine
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: AtriCure
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 03, 2021

Lead Product(s) : Paracetamol,Methocarbamol,Tramadol Hydrochloride,Bupivacaine Hydrochloride,Epinephrine
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : AtriCure
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection
Details : Tylenol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pain, Postoperative.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 03, 2021

Details:
Bupivacaine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pain, Postoperative.
Lead Product(s): Bupivacaine,Bupivacaine Hydrochloride
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: MaineHealth
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 01, 2021

Lead Product(s) : Bupivacaine,Bupivacaine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : MaineHealth
Deal Size : Inapplicable
Deal Type : Inapplicable
Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations
Details : Bupivacaine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pain, Postoperative.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 01, 2021

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Details:
GTX-101, a novel bio-adhesive film forming topical spray formulation of bupivacaine for the treatment of Postherpetic Neuralgia (PHN). GTX-101 could provide significant benefits faster onset of action and longer duration of pain relief over current standard of care.
Lead Product(s): Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 06, 2021

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Lead Product(s) : Bupivacaine Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : GTX-101, a novel bio-adhesive film forming topical spray formulation of bupivacaine for the treatment of Postherpetic Neuralgia (PHN). GTX-101 could provide significant benefits faster onset of action and longer duration of pain relief over current stand...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 06, 2021

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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.
A Bupivacaine HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupivacaine HCL, including repackagers and relabelers. The FDA regulates Bupivacaine HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupivacaine HCL 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 HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bupivacaine HCL supplier is an individual or a company that provides Bupivacaine HCL active pharmaceutical ingredient (API) or Bupivacaine HCL finished formulations upon request. The Bupivacaine HCL suppliers may include Bupivacaine HCL API manufacturers, exporters, distributors and traders.
click here to find a list of Bupivacaine HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bupivacaine HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of Bupivacaine HCL active pharmaceutical ingredient (API) in detail. Different forms of Bupivacaine HCL DMFs exist exist since differing nations have different regulations, such as Bupivacaine HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bupivacaine HCL DMF submitted to regulatory agencies in the US is known as a USDMF. Bupivacaine HCL USDMF includes data on Bupivacaine HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bupivacaine HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bupivacaine HCL 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 HCL Drug Master File in Japan (Bupivacaine HCL JDMF) empowers Bupivacaine HCL 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 HCL JDMF during the approval evaluation for pharmaceutical products. At the time of Bupivacaine HCL 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 HCL 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 HCL Drug Master File in Korea (Bupivacaine HCL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bupivacaine HCL. The MFDS reviews the Bupivacaine HCL KDMF as part of the drug registration process and uses the information provided in the Bupivacaine HCL KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bupivacaine HCL 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 HCL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bupivacaine HCL suppliers with KDMF on PharmaCompass.
A Bupivacaine HCL CEP of the European Pharmacopoeia monograph is often referred to as a Bupivacaine HCL Certificate of Suitability (COS). The purpose of a Bupivacaine HCL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bupivacaine HCL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bupivacaine HCL to their clients by showing that a Bupivacaine HCL CEP has been issued for it. The manufacturer submits a Bupivacaine HCL CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bupivacaine HCL CEP holder for the record. Additionally, the data presented in the Bupivacaine HCL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bupivacaine HCL DMF.
A Bupivacaine HCL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bupivacaine HCL CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Bupivacaine HCL written confirmation (Bupivacaine HCL WC) is an official document issued by a regulatory agency to a Bupivacaine HCL manufacturer, verifying that the manufacturing facility of a Bupivacaine HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bupivacaine HCL APIs or Bupivacaine HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a Bupivacaine HCL WC (written confirmation) as part of the regulatory process.
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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 HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bupivacaine HCL 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 HCL 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 HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bupivacaine HCL NDC to their finished compounded human drug products, they may choose to do so.
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Bupivacaine HCL 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 HCL 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 HCL GMP manufacturer or Bupivacaine HCL GMP API supplier for your needs.
A Bupivacaine HCL CoA (Certificate of Analysis) is a formal document that attests to Bupivacaine HCL's compliance with Bupivacaine HCL specifications and serves as a tool for batch-level quality control.
Bupivacaine HCL CoA mostly includes findings from lab analyses of a specific batch. For each Bupivacaine HCL 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 HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (Bupivacaine HCL EP), Bupivacaine HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bupivacaine HCL USP).