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1. Sebacoyl Dinalbuphine Ester
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)-
Molecular Weight | 881.1 g/mol |
---|---|
Molecular Formula | C52H68N2O10 |
XLogP3 | 5 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 17 |
Exact Mass | 880.48739637 g/mol |
Monoisotopic Mass | 880.48739637 g/mol |
Topological Polar Surface Area | 159 Ų |
Heavy Atom Count | 64 |
Formal Charge | 0 |
Complexity | 1640 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 10 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32476
Submission : 2018-03-26
Status : Active
Type : II
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32476
Submission : 2018-03-26
Status : Active
Type : II
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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ABOUT THIS PAGE
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.
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.
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.
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).
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.
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.
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 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.
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).
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