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Chemistry

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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]

API SUPPLIERS

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Rusan Pharma

India

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EUROAPI

France

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Sanofi

France

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Deccan Nutraceuticals Pvt. Ltd

India

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Tenatra Exports

India

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Willow Birch Pharma

U.S.A

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Rusan Pharma

India

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Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Mallinckrodt Pharmaceuticals

Ireland

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Mallinckrodt Pharmaceuticals

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Mallinckrodt Pharmaceuticals

Ireland

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Mallinckrodt Pharmaceuticals

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Mallinckrodt Pharmaceuticals

Ireland

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Mallinckrodt Pharmaceuticals

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NDC API

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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NALBUPHINE HYDROCHLORIDE

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

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CPhI India
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NALBUPHINE HYDROCHLORIDE

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...

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SpecGx LLC

Ireland
CPhI India
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SpecGx LLC

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NALBUPHINE HYDROCHLORIDE

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

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SpecGx LLC

Ireland
CPhI India
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SpecGx LLC

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NALBUPHINE HYDROCHLORIDE

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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CPhI India
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NALBUPHINE HYDROCHLORIDE

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...

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FRANCOPIA

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CPhI India
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FRANCOPIA

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NALBUPHINE HYDROCHLORIDE

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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Rusan Pharma

India
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Nalbuphine Hydrochloride

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...

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 & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
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EUROAPI

France
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Nalbuphine Hydrochloride

About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...

EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
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Virtual BoothDeccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

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Nalbuphine Hydrochloride

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...

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 commitment to quality and adherence to Current Good Manufacturing Practices (CGMP) are integral to their operations. The company has been successfully audited by USFDA (5 times) and EDQM (2 times). The company manufactures high quality phytochemicals, semi-synthetic and synthetic APIs. DNPL stands as a responsible pharmaceutical manufacturer, devoted to delivering premium products across all the regions we serve.
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Nalbuphine Hydrochloride

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...

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 opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
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Virtual BoothWillow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.

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Nalbuphine Hydrochloride

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...

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 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide.
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CPhI India
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Nalbuphine Hydrochloride

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...

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 subsidiary companies equipped with knowledgeable specialists and state-of-the-art facilities. To attain it’s determined goals, HAS benefits from technical units such as R&D department, Pharmaceutical Engineering Department, Market Research Department, Kilo Lab Unit and Mini Plant.
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CPhI India
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Nalbuphine Hydrochloride

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...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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Nalbuphine Hydrochloride

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...

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 to the market. Over these years, we have expanded our product portfolio to hormones, narcotics analgesics, steroids and more. We aspire to use our experience of over two decades to continue to provide Micro Orgo Chem’s finest drugs to those in need.
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OmnisMed Pharmaceuticals

United Kingdom
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OmnisMed Pharmaceuticals

United Kingdom
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Nalbuphine

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 ...

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 pharmaceutical products, highly tested and approved controlled drugs, and fully certifiable medical devices. All our suppliers hold several GMPs and certifications which are readily accepted by developed and developing markets. The high daily manufacturing capacity of our facilities and our distribution network allows us to quickly fulfill large orders and ensure our manufacturing process is cost-effective.
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CPhI India
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Nalbuphine Hydrochloride

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...

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 hubs like Vienna, Prague and Budapest. We, at Saneca, carry on the tradition of commitments to quality and customer service level. Everything that we do we approach from the customer perspective.
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API Reference Price

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22-Feb-2022
31-Oct-2025
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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&...

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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
  • 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

BOS Manchester
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BOS Manchester
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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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BOS Manchester
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BOS Manchester
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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...

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BOS Manchester
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BOS Manchester
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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...

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FDF Dossiers

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Rusan Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Regulatory Info :

Registration Country : India

Nalbuphine Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 10mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

02

Rusan Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Regulatory Info :

Registration Country : India

Nalbuphine Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

03

AbbVie Inc

U.S.A

NALBUPHINE HYDROCHLORIDE

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

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04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Regulatory Info : DISCN

Registration Country : USA

NALBUPHINE HYDROCHLORIDE

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

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Regulatory Info : DISCN

Registration Country : USA

NALBUPHINE HYDROCHLORIDE

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

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06

Quad Pharma

South Africa
BOS Manchester
Not Confirmed
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Quad Pharma

South Africa
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BOS Manchester
Not Confirmed

NALBUPHINE HYDROCHLORIDE

Brand Name : NALBUPHINE

Dosage Form : Injectable; Injection

Dosage Strength : 10MG/ML

Packaging :

Approval Date :

Application Number : 70692

Regulatory Info :

Registration Country : USA

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Country
BOS Manchester
Not Confirmed
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Country
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BOS Manchester
Not Confirmed

NALBUPHINE HYDROCHLORIDE

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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08

Country
BOS Manchester
Not Confirmed
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Country
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BOS Manchester
Not Confirmed

NALBUPHINE HYDROCHLORIDE

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

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09

Country
BOS Manchester
Not Confirmed
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Country
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BOS Manchester
Not Confirmed

NALBUPHINE HYDROCHLORIDE

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

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10

Country
BOS Manchester
Not Confirmed
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Country
arrow
BOS Manchester
Not Confirmed

NALBUPHINE HYDROCHLORIDE

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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ABOUT THIS PAGE

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

Nalbuphine Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Nalbuphine Hydrochloride

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 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.

Nalbuphine HCL Manufacturers

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.

Nalbuphine HCL Suppliers

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.

Nalbuphine HCL USDMF

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.

Nalbuphine HCL WC

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.

Nalbuphine HCL 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 HCL as an active pharmaceutical ingredient (API).

Finished drug products

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.

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 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.

Compounded drug products

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 GMP

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.

Nalbuphine HCL CoA

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).

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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