Find Nalbuphine Sebacate manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS Certifications

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JDMF

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EU WC

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NDC API

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Chemistry

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Also known as: Sebacoyldinalbuphine, Dinalbuphine sebacate, Naldebain, 311768-81-7, 464oxx39y6, Bis[(4r,4as,7s,7ar,12bs)-3-(cyclobutylmethyl)-4a,7-dihydroxy-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-9-yl] decanedioate
Molecular Formula
C52H68N2O10
Molecular Weight
881.1  g/mol
InChI Key
ALOIOAGKUOQNID-ITCIXCFHSA-N
FDA UNII
464OXX39Y6

Nalbuphine Sebacate
Dinalbuphine sebacate is under investigation in clinical trial NCT02468128 (A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management).
1 2D Structure

Nalbuphine Sebacate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
bis[(4R,4aS,7S,7aR,12bS)-3-(cyclobutylmethyl)-4a,7-dihydroxy-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-9-yl] decanedioate
2.1.2 InChI
InChI=1S/C52H68N2O10/c55-35-19-21-51(59)39-27-33-15-17-37(45-43(33)49(51,47(35)63-45)23-25-53(39)29-31-9-7-10-31)61-41(57)13-5-3-1-2-4-6-14-42(58)62-38-18-16-34-28-40-52(60)22-20-36(56)48-50(52,44(34)46(38)64-48)24-26-54(40)30-32-11-8-12-32/h15-18,31-32,35-36,39-40,47-48,55-56,59-60H,1-14,19-30H2/t35-,36-,39+,40+,47-,48-,49-,50-,51+,52+/m0/s1
2.1.3 InChI Key
ALOIOAGKUOQNID-ITCIXCFHSA-N
2.1.4 Canonical SMILES
C1CC(C1)CN2CCC34C5C(CCC3(C2CC6=C4C(=C(C=C6)OC(=O)CCCCCCCCC(=O)OC7=C8C9=C(CC1C2(C9(CCN1CC1CCC1)C(O8)C(CC2)O)O)C=C7)O5)O)O
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)OC(=O)CCCCCCCCC(=O)OC7=C8C9=C(C[C@@H]1[C@]2([C@]9(CCN1CC1CCC1)[C@@H](O8)[C@H](CC2)O)O)C=C7)O5)O)O
2.2 Other Identifiers
2.2.1 UNII
464OXX39Y6
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Sebacoyl Dinalbuphine Ester

2.3.2 Depositor-Supplied Synonyms

1. Sebacoyldinalbuphine

2. Dinalbuphine Sebacate

3. Naldebain

4. 311768-81-7

5. 464oxx39y6

6. Bis[(4r,4as,7s,7ar,12bs)-3-(cyclobutylmethyl)-4a,7-dihydroxy-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-9-yl] Decanedioate

7. Sebacoyl Dinalbuphine Ester

8. Nalbuphine Sebacate [inn]

9. Unii-464oxx39y6

10. Chembl1823241

11. Dtxsid601336353

12. Dinalbuphine Sebacate [inn]

13. Nalbuphine Sebacate [who-dd]

14. Db15341

15. Q27258899

16. Bis(17-(cyclobutylmethyl)-4,5alpha-epoxy-6alpha,14-dihydroxymorphinan-3-yl) Decanedioate

17. Bis(17-(cyclobutylmethyl)-4,5.alpha.-epoxy-6.alpha.,14-dihydroxymorphinan-3-yl) Decanedioate

18. Morphinan-3,6,14-triol, 17-(cyclobutylmethyl)-4,5-epoxy-, 3,3'-decanedioate, (5.alpha.,6.alpha.)-(5'.alpha.,6'.alpha.)-

19. Morphinan-3,6,14-triol, 17-(cyclobutylmethyl)-4,5-epoxy-, 3,3'-decanedioate, (5alpha,6alpha)-(5'alpha,6'alpha)-

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 881.1 g/mol
Molecular Formula C52H68N2O10
XLogP35
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count12
Rotatable Bond Count17
Exact Mass880.48739637 g/mol
Monoisotopic Mass880.48739637 g/mol
Topological Polar Surface Area159 Ų
Heavy Atom Count64
Formal Charge0
Complexity1640
Isotope Atom Count0
Defined Atom Stereocenter Count10
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

Rusan Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Rusan Pharma

02

Formosa Laboratories

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Formosa Laboratories

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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03

OmnisMed Pharmaceuticals

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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OmnisMed Pharmaceuticals

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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NDC API

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BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
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DINALBUPHINE SEBACATE

NDC Package Code : 66499-0060

Start Marketing Date : 2018-04-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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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.

Flag India
Digital Content Digital Content

Dinalbuphine Sebacate

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.
Rusan Pharma

02

OmnisMed Pharmaceuticals

United Kingdom
BIO Partnering at JPM
Not Confirmed
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OmnisMed Pharmaceuticals

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Nalbuphine Sebacate

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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Market Place

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ABOUT THIS PAGE

Nalbuphine Sebacate Manufacturers

A Nalbuphine Sebacate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalbuphine Sebacate, including repackagers and relabelers. The FDA regulates Nalbuphine Sebacate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalbuphine Sebacate 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 Sebacate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Nalbuphine Sebacate Suppliers

A Nalbuphine Sebacate supplier is an individual or a company that provides Nalbuphine Sebacate active pharmaceutical ingredient (API) or Nalbuphine Sebacate finished formulations upon request. The Nalbuphine Sebacate suppliers may include Nalbuphine Sebacate API manufacturers, exporters, distributors and traders.

click here to find a list of Nalbuphine Sebacate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Nalbuphine Sebacate USDMF

A Nalbuphine Sebacate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalbuphine Sebacate active pharmaceutical ingredient (API) in detail. Different forms of Nalbuphine Sebacate DMFs exist exist since differing nations have different regulations, such as Nalbuphine Sebacate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Nalbuphine Sebacate DMF submitted to regulatory agencies in the US is known as a USDMF. Nalbuphine Sebacate USDMF includes data on Nalbuphine Sebacate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalbuphine Sebacate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Nalbuphine Sebacate suppliers with USDMF on PharmaCompass.

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

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Nalbuphine Sebacate 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 Sebacate 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 Sebacate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nalbuphine Sebacate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Nalbuphine Sebacate suppliers with NDC on PharmaCompass.

Nalbuphine Sebacate GMP

Nalbuphine Sebacate 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 Sebacate 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 Sebacate GMP manufacturer or Nalbuphine Sebacate GMP API supplier for your needs.

Nalbuphine Sebacate CoA

A Nalbuphine Sebacate CoA (Certificate of Analysis) is a formal document that attests to Nalbuphine Sebacate's compliance with Nalbuphine Sebacate specifications and serves as a tool for batch-level quality control.

Nalbuphine Sebacate CoA mostly includes findings from lab analyses of a specific batch. For each Nalbuphine Sebacate 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 Sebacate may be tested according to a variety of international standards, such as European Pharmacopoeia (Nalbuphine Sebacate EP), Nalbuphine Sebacate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nalbuphine Sebacate 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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