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1. En 2234a
2. En-2234a
3. En2234a
4. Nalbuphine
5. Nalbuphine Serb
6. Nubain
1. Nubain
2. Nalbuphine Hcl
3. 23277-43-2
4. Nalbuphine Hydrochloride [usan]
5. En-2234a
6. Nalbufine Hydrochloride
7. Nsc-757829
8. Zu4275277r
9. (4r,4as,7s,7ar,12bs)-3-(cyclobutylmethyl)-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,7,9-triol;hydrochloride
10. Nalbuphine Hydrochloride (usan)
11. Chebi:7455
12. Nalbufina Clorhidrato [spanish]
13. En 2234a
14. Einecs 245-549-9
15. Nalbuphinehydrochloride
16. Unii-zu4275277r
17. Prestwick_344
18. Nubain (tn)
19. 17-(cyclobutylmethyl)-4,5alpha-epoxymorphinan-3,6alpha,14-triol Hydrochloride
20. (5alpha,6alpha)-17-(cyclobutylmethyl)-4,5-epoxymorphinan-3,6,14-triol Hydrochloride
21. Morphinan-3,6,14-triol, 17-(cyclobutylmethyl)-4,5-epoxy-, Hydrochloride, (5-alpha,6-alpha)-
22. Schembl41123
23. Mls002154202
24. Chembl1201132
25. Dtxsid20177844
26. Hms1568g18
27. Nalbuphine Hydrochloride [mi]
28. Ccg-220118
29. Nsc 757829
30. Pw-4142
31. Morphinan-3,6,14-triol, 17-(cyclobutylmethyl)-4,5-epoxy-, Hydrochloride, (5alpha,6alpha)-
32. Morphinan-3,6-alpha,14-triol, 17-(cyclobutylmethyl)-4,5-alpha-epoxy-, Hydrochloride
33. Nalbuphine Hydrochloride [mart.]
34. Nalbuphine Hydrochloride [vandf]
35. Nalbuphine Hydrochloride [who-dd]
36. Bn161328
37. Smr001233488
38. Nalbuphine Hydrochloride [orange Book]
39. D00843
40. E98629
41. Q27107499
42. (-)-17-(cyclobutylmethyl)- 4,5a-epoxymorphinan- 3,6a,14-triol Hydrochloride
43. 17-(cyclobutylmethyl)-4,5.alpha.-epoxymorphinan-3,6.alpha.,14-triol Hydrochloride
44. Morphinan-3,6,14-triol, 17-(cyclobutylmethyl)-4,5-epoxy-, Hydrochloride, (5.alpha.,6.alpha.)-
45. Nalbuphine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
| Molecular Weight | 393.9 g/mol |
|---|---|
| Molecular Formula | C21H28ClNO4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 2 |
| Exact Mass | 393.1706861 g/mol |
| Monoisotopic Mass | 393.1706861 g/mol |
| Topological Polar Surface Area | 73.2 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 597 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Nalbuphine hydrochloride |
| Drug Label | AmpulFliptop VialProtect from light.Rx OnlyNalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid ana... |
| Active Ingredient | Nalbuphine hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20mg/ml; 10mg/ml |
| Market Status | Prescription |
| Company | Hospira |
| 2 of 2 | |
|---|---|
| Drug Name | Nalbuphine hydrochloride |
| Drug Label | AmpulFliptop VialProtect from light.Rx OnlyNalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid ana... |
| Active Ingredient | Nalbuphine hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20mg/ml; 10mg/ml |
| Market Status | Prescription |
| Company | Hospira |
Analgesics, Opioid
Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)
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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 20mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1.5MG/ML
Packaging :
Approval Date : 1993-03-12
Application Number : 20200
Regulatory Info : DISCN
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 1998-03-19
Application Number : 74471
Regulatory Info : DISCN
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/ML
Packaging :
Approval Date : 1998-03-19
Application Number : 74471
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/ML
Packaging :
Approval Date : 1989-02-03
Application Number : 70916
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 1989-04-10
Application Number : 72070
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/ML
Packaging :
Approval Date : 1989-04-10
Application Number : 72075
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Generic B.E study
Registration Country : South Korea
Brand Name : Nalpain
Dosage Form : INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic B.E study
Registration Country : South Korea
Regulatory Info : RX
Registration Country : USA
Brand Name : NALBUPHINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML
Packaging :
Approval Date : 2024-09-19
Application Number : 216049
Regulatory Info : RX
Registration Country : USA
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Regulatory Info :
Registration Country : Ukraine
Brand Name : Nalbuk
Dosage Form : Solution for Injection
Dosage Strength : 10MG/ML
Packaging : 1ML, 2ML Ampoule; 1ML Syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Sweden
Brand Name : Nalpain
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 10 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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ABOUT THIS PAGE
A Nalbuphine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalbuphine Hydrochloride, including repackagers and relabelers. The FDA regulates Nalbuphine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalbuphine 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 Nalbuphine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalbuphine Hydrochloride supplier is an individual or a company that provides Nalbuphine Hydrochloride active pharmaceutical ingredient (API) or Nalbuphine Hydrochloride finished formulations upon request. The Nalbuphine Hydrochloride suppliers may include Nalbuphine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Nalbuphine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nalbuphine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalbuphine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Nalbuphine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Nalbuphine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nalbuphine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Nalbuphine Hydrochloride USDMF includes data on Nalbuphine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalbuphine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nalbuphine Hydrochloride suppliers with USDMF on PharmaCompass.
A Nalbuphine Hydrochloride written confirmation (Nalbuphine Hydrochloride WC) is an official document issued by a regulatory agency to a Nalbuphine Hydrochloride manufacturer, verifying that the manufacturing facility of a Nalbuphine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nalbuphine Hydrochloride APIs or Nalbuphine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Nalbuphine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Nalbuphine 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 Nalbuphine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nalbuphine 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 Nalbuphine 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 Nalbuphine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nalbuphine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nalbuphine Hydrochloride suppliers with NDC on PharmaCompass.
Nalbuphine 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 Nalbuphine 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 Nalbuphine Hydrochloride GMP manufacturer or Nalbuphine Hydrochloride GMP API supplier for your needs.
A Nalbuphine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Nalbuphine Hydrochloride's compliance with Nalbuphine Hydrochloride specifications and serves as a tool for batch-level quality control.
Nalbuphine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Nalbuphine 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.
Nalbuphine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Nalbuphine Hydrochloride EP), Nalbuphine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nalbuphine Hydrochloride USP).
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