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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.)
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2013-11-15
DMF Number : 21144
Submission : 2007-06-20
Status : Active
Type : II
| Available Reg Filing : ASMF, CN |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
NDC Package Code : 50396-0201
Start Marketing Date : 2018-06-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11421
Submission : 1995-03-31
Status : Active
Type : II
NDC Package Code : 0406-3360
Start Marketing Date : 2010-06-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-23
Pay. Date : 2013-12-24
DMF Number : 23604
Submission : 2010-04-29
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2883
Submission : 1977-03-18
Status : Inactive
Type : II
NDC Package Code : 0406-3310
Start Marketing Date : 2013-11-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
NDC Package Code : 50396-0201
Start Marketing Date : 2018-06-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62991-1546
Start Marketing Date : 2010-11-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 0406-3360
Start Marketing Date : 2010-06-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 0406-3310
Start Marketing Date : 2013-11-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 51927-2140
Start Marketing Date : 2013-06-20
End Marketing Date : 2028-02-28
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 52465-106
Start Marketing Date : 2018-06-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
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Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
About the Company : Hasti Aria Shimi (H.A.S.) is established in 2010 as an R&D center of GPI. This company states (determined) R&D activities for developing API and technical know-how to other subsidi...

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

About the Company : Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs t...

About the Company : OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality ...

About the Company : We are the largest pharmaceutical company in Slovakia with site originally established in the 1940s. Our multi-purpose headquarters is easily reachable from all central European hu...

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|---|
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CAS Number : 5006-22-4
End Use API : Nalbuphine Hydrochloride
About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...
CAS Number : 3721-95-7
End Use API : Nalbuphine Hydrochloride
About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...
CAS Number : 4415-82-1
End Use API : Nalbuphine Hydrochloride
About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...
2,2,2-Trichloroethyl chloroformate
CAS Number : 17341-93-4
End Use API : Nalbuphine Hydrochloride
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
CAS Number : 3721-95-7
End Use API : Nalbuphine Hydrochloride
About The Company : Innovassynth Technologies (I) Ltd. formerly known as Chemicals Division of Indian Organic Chemicals Ltd. came in to existence since 1st August 2002. It is a par...

CAS Number : 2987-17-9
End Use API : Nalbuphine Hydrochloride
About The Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, fr...

CAS Number : 5006-22-4
End Use API : Nalbuphine Hydrochloride
About The Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, fr...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 20mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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 : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 100MG/10ML (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 : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 200MG/10ML (20MG/ML)
Packaging :
Approval Date : 1998-03-19
Application Number : 74471
Regulatory Info : DISCN
Registration Country : USA
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Regulatory Info :
Registration Country : USA
Brand Name : NALBUPHINE
Dosage Form : Injectable; Injection
Dosage Strength : 10MG/ML
Packaging :
Approval Date :
Application Number : 70692
Regulatory Info :
Registration Country : USA

Regulatory Info : DISCN
Registration Country : USA
Brand Name : NUBAIN
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 18024
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : NUBAIN
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-05-27
Application Number : 18024
Regulatory Info : DISCN
Registration Country : USA

Portfolio PDF
Product Web Link
Virtual Booth
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Website
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : NUBAIN
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 18024
Regulatory Info : DISCN
Registration Country : USA

Portfolio PDF
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : NUBAIN
Dosage Form : SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 18024
Regulatory Info : DISCN
Registration Country : USA

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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PharmaCompass offers a list of Nalbuphine 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 Nalbuphine Hydrochloride manufacturer or Nalbuphine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nalbuphine Hydrochloride manufacturer or Nalbuphine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Nalbuphine Hydrochloride API Price utilized in the formulation of products. Nalbuphine Hydrochloride API Price is not always fixed or binding as the Nalbuphine Hydrochloride Price is obtained through a variety of data sources. The Nalbuphine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nalbuphine HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalbuphine HCL, including repackagers and relabelers. The FDA regulates Nalbuphine HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalbuphine 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 Nalbuphine HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalbuphine HCL supplier is an individual or a company that provides Nalbuphine HCL active pharmaceutical ingredient (API) or Nalbuphine HCL finished formulations upon request. The Nalbuphine HCL suppliers may include Nalbuphine HCL API manufacturers, exporters, distributors and traders.
click here to find a list of Nalbuphine HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nalbuphine HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalbuphine HCL active pharmaceutical ingredient (API) in detail. Different forms of Nalbuphine HCL DMFs exist exist since differing nations have different regulations, such as Nalbuphine HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nalbuphine HCL DMF submitted to regulatory agencies in the US is known as a USDMF. Nalbuphine HCL USDMF includes data on Nalbuphine HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalbuphine HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nalbuphine HCL suppliers with USDMF on PharmaCompass.
A Nalbuphine HCL written confirmation (Nalbuphine HCL WC) is an official document issued by a regulatory agency to a Nalbuphine HCL manufacturer, verifying that the manufacturing facility of a Nalbuphine HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nalbuphine HCL APIs or Nalbuphine HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a Nalbuphine HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of Nalbuphine HCL 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 HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nalbuphine 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 Nalbuphine 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 Nalbuphine HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nalbuphine HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nalbuphine HCL suppliers with NDC on PharmaCompass.
Nalbuphine 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 Nalbuphine 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 Nalbuphine HCL GMP manufacturer or Nalbuphine HCL GMP API supplier for your needs.
A Nalbuphine HCL CoA (Certificate of Analysis) is a formal document that attests to Nalbuphine HCL's compliance with Nalbuphine HCL specifications and serves as a tool for batch-level quality control.
Nalbuphine HCL CoA mostly includes findings from lab analyses of a specific batch. For each Nalbuphine 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.
Nalbuphine HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (Nalbuphine HCL EP), Nalbuphine HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nalbuphine HCL USP).