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Also known as: Nubain, Nalbuphine hcl, 23277-43-2, Nalbuphine hydrochloride [usan], En-2234a, Nalbufine hydrochloride
Molecular Formula
C21H28ClNO4
Molecular Weight
393.9  g/mol
InChI Key
YZLZPSJXMWGIFH-BCXQGASESA-N
FDA UNII
ZU4275277R

Nalbuphine Hydrochloride
A narcotic used as a pain medication. It appears to be an agonist at KAPPA RECEPTORS and an antagonist or partial agonist at MU RECEPTORS.
1 2D Structure

Nalbuphine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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
2.1.2 InChI
InChI=1S/C21H27NO4.ClH/c23-14-5-4-13-10-16-21(25)7-6-15(24)19-20(21,17(13)18(14)26-19)8-9-22(16)11-12-2-1-3-12;/h4-5,12,15-16,19,23-25H,1-3,6-11H2;1H/t15-,16+,19-,20-,21+;/m0./s1
2.1.3 InChI Key
YZLZPSJXMWGIFH-BCXQGASESA-N
2.1.4 Canonical SMILES
C1CC(C1)CN2CCC34C5C(CCC3(C2CC6=C4C(=C(C=C6)O)O5)O)O.Cl
2.1.5 Isomeric SMILES
C1CC(C1)CN2CC[C@]34[C@@H]5[C@H](CC[C@]3([C@H]2CC6=C4C(=C(C=C6)O)O5)O)O.Cl
2.2 Other Identifiers
2.2.1 UNII
ZU4275277R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. En 2234a

2. En-2234a

3. En2234a

4. Nalbuphine

5. Nalbuphine Serb

6. Nubain

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 393.9 g/mol
Molecular Formula C21H28ClNO4
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass393.1706861 g/mol
Monoisotopic Mass393.1706861 g/mol
Topological Polar Surface Area73.2 Ų
Heavy Atom Count27
Formal Charge0
Complexity597
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameNalbuphine hydrochloride
Drug LabelAmpulFliptop 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 IngredientNalbuphine hydrochloride
Dosage FormInjectable
RouteInjection
Strength20mg/ml; 10mg/ml
Market StatusPrescription
CompanyHospira

2 of 2  
Drug NameNalbuphine hydrochloride
Drug LabelAmpulFliptop 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 IngredientNalbuphine hydrochloride
Dosage FormInjectable
RouteInjection
Strength20mg/ml; 10mg/ml
Market StatusPrescription
CompanyHospira

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Agonist/Antagonist [EPC]; Partial Opioid Agonists [MoA]; Competitive Opioid Antagonists [MoA]

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STATES","foreign_port":"NA","customer":"NOVARTIS PHARMACEUTICALS CORPORATION","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7500","totalValueFC":"7663.8","currency":"USD","unitRateINR":"629882.1","date":"01-Jul-2023","totalValueINR":"629882.113","totalValueInUsd":"7663.8","indian_port":"HYDERABAD AIR","hs_no":"29391900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"INSPIRE BKC PART OF 601 AND 701,BA NDRAKURLA COMPLEX BANDRA EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694197800,"product":"NALBUPHINE HYDROCHLORIDE (1P)","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"N\/A","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7500","totalValueFC":"7585.1","currency":"USD","unitRateINR":"629625","date":"09-Sep-2023","totalValueINR":"629625","totalValueInUsd":"7585.1","indian_port":"Madras Air","hs_no":"29391900","bill_no":"7746770","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"PERTH HOUSE MILLENNIUM WAY, DUNSTON CHESTERFILED, DERBYSHIRE S41 8ND U NITED STATES Derby, , United States United States","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699986600,"product":"NALBUPHINE HYDROCHLORIDE","address":"NO.18,DR NAIR ROAD, T NAGAR,","city":"CHENNAI","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS","customer":"STERIL-GENE LIFE SCIENCES (P) LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"9156","totalValueFC":"49397","currency":"EUR","unitRateINR":"822666.6","date":"15-Nov-2023","totalValueINR":"4113333","totalValueInUsd":"49397","indian_port":"Madras Air","hs_no":"29420090","bill_no":"8768153","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS","supplierAddress":"REGISTERED OFFICE 15,RUETRAVERSIERE 75012PARIS FRANCE","customerAddress":"NO.18,DR NAIR ROAD, T NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712773800,"product":"NALBUPHINE HYDROCHLORIDE","address":"NO.18,DR NAIR ROAD, T NAGAR,","city":"CHENNAI","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS","customer":"STERIL-GENE LIFE SCIENCES (P) LTD","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"9156","totalValueFC":"40370.6","currency":"EUR","unitRateINR":"842809.8","date":"11-Apr-2024","totalValueINR":"3371239.2","totalValueInUsd":"40370.6","indian_port":"Madras Air","hs_no":"29420090","bill_no":"2972681","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS","supplierAddress":"REGISTERED OFFICE 15,RUETRAVERSIERE 75012PARIS FRANCE","customerAddress":"NO.18,DR NAIR ROAD, T NAGAR,"}]
16-Mar-2021
27-Dec-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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INTERMEDIATE SUPPLIERS

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01

Minakem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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&...

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02

Minakem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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&...

Minakem Comapny Banner

03

Minakem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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&...

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04

PMC Isochem

France
Biotech Digital Meet
Not Confirmed
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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...

PMC Isochem

05

Biotech Digital Meet
Not Confirmed
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothM2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.

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...

m2i group

06

Biotech Digital Meet
Not Confirmed
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothM2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.

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...

m2i group

07

Biotech Digital Meet
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Biotech Digital Meet
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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...

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ABOUT THIS PAGE

Looking for 23277-43-2 / Nalbuphine API manufacturers, exporters & distributors?

Nalbuphine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Nalbuphine 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 manufacturer or Nalbuphine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nalbuphine manufacturer or Nalbuphine supplier.

PharmaCompass also assists you with knowing the Nalbuphine API Price utilized in the formulation of products. Nalbuphine API Price is not always fixed or binding as the Nalbuphine Price is obtained through a variety of data sources. The Nalbuphine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Nalbuphine

Synonyms

Nubain, Nalbuphine hcl, 23277-43-2, Nalbuphine hydrochloride [usan], En-2234a, Nalbufine hydrochloride

Cas Number

23277-43-2

Unique Ingredient Identifier (UNII)

ZU4275277R

About Nalbuphine

A narcotic used as a pain medication. It appears to be an agonist at KAPPA RECEPTORS and an antagonist or partial agonist at MU RECEPTORS.

Nalbuphine Hydrochloride Manufacturers

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.

Nalbuphine Hydrochloride Suppliers

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.

Nalbuphine Hydrochloride USDMF

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.

Nalbuphine Hydrochloride WC

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.

Nalbuphine Hydrochloride NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Nalbuphine Hydrochloride CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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