Synopsis
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USP
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JP
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FDA Orange Book
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1. Acupan
2. Ajan
3. Fenazoxine
4. Hydrochloride, Nefopam
5. Nefopam
6. Nefopam, Silentan
7. Silentan Nefopam
1. 23327-57-3
2. Nefopam Hcl
3. Acupan
4. Fenazoxine Hydrochloride
5. 5-methyl-1-phenyl-3,4,5,6-tetrahydro-1h-benzo[f][1,4]oxazocine Hydrochloride
6. Nefopam (hydrochloride)
7. Nefopam Hydrochloride [usan]
8. 5-methyl-1-phenyl-3,4,5,6-tetrahydro-1h-2,5-benzoxazocine Hydrochloride
9. 3,4,5,6-tetrahydro-5-methyl-1-phenyl-1h-2,5-benzoxazocine Hydrochloride
10. 1h-2,5-benzoxazocine, 3,4,5,6-tetrahydro-5-methyl-1-phenyl-, Hydrochloride (1:1)
11. 685j48e13w
12. Nsc-757856
13. 23327-57-3 (hcl)
14. 5-methyl-1-phenyl-1,3,4,6-tetrahydro-2,5-benzoxazocine;hydrochloride
15. 1h-2,5-benzoxazocine, 3,4,5,6-tetrahydro-5-methyl-1-phenyl-, Hydrochloride
16. Dsstox_cid_25441
17. Dsstox_rid_80882
18. Dsstox_gsid_45441
19. Nefopam Hydrochloride (usan)
20. Leoplexamin
21. Pallopikeron
22. Lenipan
23. Sinalgico
24. Oxadol
25. Ajan
26. Smr000514529
27. Sr-01000388442
28. Unii-685j48e13w
29. Prestwick_351
30. Einecs 245-585-5
31. Nefopan Hydrochloride
32. Acupan (tn)
33. 69319-31-9
34. Ncgc00016778-01
35. R 738
36. Cas-23327-57-3
37. Mls001210851
38. Mls001240198
39. Mls002222204
40. Schembl122057
41. Chembl1407915
42. Dtxsid7045441
43. Hms1568n19
44. Nefopam Hydrochloride [mi]
45. Bcp13749
46. Hy-b1057
47. Tox21_110606
48. Mfcd00012750
49. S4180
50. Nefopam Hydrochloride [mart.]
51. 5-methyl-1-phenyl-3,4,5,6-tetrahydro-1h-benzo[f][1,4]oxazocinehydrochloride
52. Akos015845828
53. Nefopam Hydrochloride [who-dd]
54. Tox21_110606_1
55. Ccg-220229
56. Cs-4579
57. Nsc 757856
58. Nefopam Hydrochloride, >=98% (hplc)
59. Ncgc00094906-06
60. Ac-11999
61. As-13286
62. Cas#23327-57-3
63. Db-046129
64. Ft-0630499
65. N1169
66. C74201
67. D05133
68. Sr-01000388442-1
69. Sr-01000388442-4
70. Q27264216
71. Fenazoxine Hydrochloride; Lenipan; Leoplexamin; Nefopam Hcl
72. Nefopam Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
73. 5-benzoxazocine,5-methyl-1-phenyl-3,4,5,6-tetrahydro-1h-hydrochloride
74. 5-methyl-1-phenyl-3,4,5,6-tetrahydro-1h-benzo[f][1,4]oxazocine Hcl
75. 1h-2,5-benzoxazocine, 5-methyl-1-phenyl-3,4,5,6-tetrahydro-, Hydrochloride
| Molecular Weight | 289.8 g/mol |
|---|---|
| Molecular Formula | C17H20ClNO |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 1 |
| Exact Mass | 289.1233420 g/mol |
| Monoisotopic Mass | 289.1233420 g/mol |
| Topological Polar Surface Area | 12.5 Ų |
| Heavy Atom Count | 20 |
| Formal Charge | 0 |
| Complexity | 274 |
| 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 |
Analgesics, Non-Narcotic
A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
Details:
The deal aims to advance Nefopam HCl, a miscellaneous product, targeting dopamine/serotonin/norepinephrine reuptake.
Lead Product(s): Nefopam Hydrochloride,Inapplicable
Therapeutic Area: Neurology Brand Name: Panagesic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Ethypharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 13, 2025
Lead Product(s) : Nefopam Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Ethypharm
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Ethypharm Iberia Adds NEFOPAM to Portfolio
Details : The deal aims to advance Nefopam HCl, a miscellaneous product, targeting dopamine/serotonin/norepinephrine reuptake.
Product Name : Panagesic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
May 13, 2025
Details:
MAX-001 (Nefopam HCl) is a non-opioid, non-NSAID oral therapy, which is currently being evaluated for the treatment of patients with acute and chronic pain.
Lead Product(s): Nefopam 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 March 18, 2025
Lead Product(s) : Nefopam Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Maxona Pharmaceuticals Announces MAX-OO1 Phase 1 Clinical Program Results
Details : MAX-001 (Nefopam HCl) is a non-opioid, non-NSAID oral therapy, which is currently being evaluated for the treatment of patients with acute and chronic pain.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 18, 2025
Details:
The company's initial focus is on advancing MAX-001 as a safe and highly effective non-opioid option for the treatment of acute and chronic pain.
Lead Product(s): Nefopam 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 February 11, 2025
Lead Product(s) : Nefopam Hydrochloride,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Maxona Pharmaceuticals Exits Stealth, Advances MAX-001 First-To-Market Candidate
Details : The company's initial focus is on advancing MAX-001 as a safe and highly effective non-opioid option for the treatment of acute and chronic pain.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 11, 2025
Details:
Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Nefopam Hydrochloride,Paracetamol
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Accutest Research Lab I Pvt. Ltd
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 22, 2021
Lead Product(s) : Nefopam Hydrochloride,Paracetamol
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Accutest Research Lab I Pvt. Ltd
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 22, 2021
Details:
Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acute Pain.
Lead Product(s): Nefopam Hydrochloride,Paracetamol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Excelya
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 10, 2020
Lead Product(s) : Nefopam Hydrochloride,Paracetamol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Excelya
Deal Size : Inapplicable
Deal Type : Inapplicable
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
Details : Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acute Pain.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 10, 2020
Details:
Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Nefopam Hydrochloride,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 16, 2017
Lead Product(s) : Nefopam Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Nefopam Hydrochloride 30mg Tablets vs Acupan® 30mg Tablets in Healthy S...
Details : Nefopam HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 16, 2017
Details:
Nefopam is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of undefined medical condition.
Lead Product(s): Nefopam Hydrochloride,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Pharmbio Korea
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 04, 2015
Lead Product(s) : Nefopam Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Pharmbio Korea
Deal Size : Inapplicable
Deal Type : Inapplicable
Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia
Details : Nefopam is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 04, 2015
Details:
Nefopam is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of undefined medical condition.
Lead Product(s): Nefopam Hydrochloride,Metoclopramide,Ranitidine,Meperidine,Ephedrine,Oxytocin,Tramadol Hydrochloride
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2015
Lead Product(s) : Nefopam Hydrochloride,Metoclopramide,Ranitidine,Meperidine,Ephedrine,Oxytocin,Tramadol Hydrochloride
Therapeutic Area : Undisclosed
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering
Details : Nefopam is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 12, 2015
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Acupan
Dosage Form : Solution For Injection
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 2010-02-22
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Ukraine
Brand Name : Product Under Development
Dosage Form : Solution for Injection
Dosage Strength : 10MG/ML
Packaging : 2ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : South Korea
Brand Name : Nefpam Injection
Dosage Form : Injection
Dosage Strength : 10MG
Packaging : SVP(Ampoule)
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Nuovopan
Dosage Form : Solution For Injection And Infusion
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 2023-02-21
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Regulatory Info :
Registration Country :
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :
Regulatory Info : Suspended
Registration Country : Malta
Brand Name : Nefopam Hydrochloride
Dosage Form : Film Coated Tablet
Dosage Strength : 30MG
Packaging :
Approval Date : 2018-08-06
Application Number :
Regulatory Info : Suspended
Registration Country : Malta
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PharmaCompass offers a list of Nefopam 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 Nefopam Hydrochloride manufacturer or Nefopam Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nefopam Hydrochloride manufacturer or Nefopam Hydrochloride supplier.
PharmaCompass also assists you with knowing the Nefopam Hydrochloride API Price utilized in the formulation of products. Nefopam Hydrochloride API Price is not always fixed or binding as the Nefopam Hydrochloride Price is obtained through a variety of data sources. The Nefopam Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nefopam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nefopam, including repackagers and relabelers. The FDA regulates Nefopam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nefopam 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 Nefopam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nefopam supplier is an individual or a company that provides Nefopam active pharmaceutical ingredient (API) or Nefopam finished formulations upon request. The Nefopam suppliers may include Nefopam API manufacturers, exporters, distributors and traders.
click here to find a list of Nefopam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nefopam DMF (Drug Master File) is a document detailing the whole manufacturing process of Nefopam active pharmaceutical ingredient (API) in detail. Different forms of Nefopam DMFs exist exist since differing nations have different regulations, such as Nefopam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nefopam DMF submitted to regulatory agencies in the US is known as a USDMF. Nefopam USDMF includes data on Nefopam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nefopam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nefopam suppliers with USDMF 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 Nefopam Drug Master File in Korea (Nefopam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nefopam. The MFDS reviews the Nefopam KDMF as part of the drug registration process and uses the information provided in the Nefopam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nefopam 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 Nefopam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nefopam suppliers with KDMF on PharmaCompass.
A Nefopam written confirmation (Nefopam WC) is an official document issued by a regulatory agency to a Nefopam manufacturer, verifying that the manufacturing facility of a Nefopam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nefopam APIs or Nefopam finished pharmaceutical products to another nation, regulatory agencies frequently require a Nefopam WC (written confirmation) as part of the regulatory process.
click here to find a list of Nefopam suppliers with Written Confirmation (WC) on PharmaCompass.
Nefopam 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 Nefopam 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 Nefopam GMP manufacturer or Nefopam GMP API supplier for your needs.
A Nefopam CoA (Certificate of Analysis) is a formal document that attests to Nefopam's compliance with Nefopam specifications and serves as a tool for batch-level quality control.
Nefopam CoA mostly includes findings from lab analyses of a specific batch. For each Nefopam 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.
Nefopam may be tested according to a variety of international standards, such as European Pharmacopoeia (Nefopam EP), Nefopam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nefopam USP).
