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Chemistry

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Also known as: Vinorelbine tartrate, 125317-39-7, Kw 2307, Navelbine (tn), Vinorelbine ditartrate (jan), Vinorelbine bitartarate
Molecular Formula
C53H66N4O20
Molecular Weight
1079.1  g/mol
InChI Key
CILBMBUYJCWATM-NPJYPKOYSA-N

Vinorelbine Tartrate
A vinca alkaloid related to VINBLASTINE that is used as a first-line treatment for NON-SMALL CELL LUNG CANCER, or for advanced or metastatic BREAST CANCER refractory to treatment with ANTHRACYCLINES.
1 2D Structure

Vinorelbine Tartrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R,3R)-2,3-dihydroxybutanedioic acid;methyl (1R,9R,10S,11R,12R,19R)-11-acetyloxy-12-ethyl-4-[(12S)-16-ethyl-12-methoxycarbonyl-1,10-diazatetracyclo[12.3.1.03,11.04,9]octadeca-3(11),4,6,8,15-pentaen-12-yl]-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca-2,4,6,13-tetraene-10-carboxylate
2.1.2 InChI
InChI=1S/C45H54N4O8.2C4H6O6/c1-8-27-19-28-22-44(40(51)55-6,36-30(25-48(23-27)24-28)29-13-10-11-14-33(29)46-36)32-20-31-34(21-35(32)54-5)47(4)38-43(31)16-18-49-17-12-15-42(9-2,37(43)49)39(57-26(3)50)45(38,53)41(52)56-7;2*5-1(3(7)8)2(6)4(9)10/h10-15,19-21,28,37-39,46,53H,8-9,16-18,22-25H2,1-7H3;2*1-2,5-6H,(H,7,8)(H,9,10)/t28?,37-,38+,39+,42+,43+,44-,45-;2*1-,2-/m011/s1
2.1.3 InChI Key
CILBMBUYJCWATM-NPJYPKOYSA-N
2.1.4 Canonical SMILES
CCC1=CC2CC(C3=C(CN(C2)C1)C4=CC=CC=C4N3)(C5=C(C=C6C(=C5)C78CCN9C7C(C=CC9)(C(C(C8N6C)(C(=O)OC)O)OC(=O)C)CC)OC)C(=O)OC.C(C(C(=O)O)O)(C(=O)O)O.C(C(C(=O)O)O)(C(=O)O)O
2.1.5 Isomeric SMILES
CCC1=CC2C[C@@](C3=C(CN(C2)C1)C4=CC=CC=C4N3)(C5=C(C=C6C(=C5)[C@]78CCN9[C@H]7[C@@](C=CC9)([C@H]([C@@]([C@@H]8N6C)(C(=O)OC)O)OC(=O)C)CC)OC)C(=O)OC.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 5' Nor Anhydrovinblastine

2. 5'-nor-anhydrovinblastine

3. Kw 2307

4. Kw-2307

5. Kw2307

6. Navelbine

7. Vinorelbine

8. Vinorelbine Tartrate

2.2.2 Depositor-Supplied Synonyms

1. Vinorelbine Tartrate

2. 125317-39-7

3. Kw 2307

4. Navelbine (tn)

5. Vinorelbine Ditartrate (jan)

6. Vinorelbine Bitartarate

7. Vinorelbine Tartrate (usp)

8. Schembl4334811

9. Schembl16766511

10. Amy22244

11. S4269

12. Akos037748842

13. Ccg-270632

14. As-75352

15. D01935

16. Bis((2r,3r)-2,3-dihydroxybutanedioic Acid); Methyl (1r,9r,10s,11r,12r,19r)-11-(acetyloxy)-12-ethyl-4-[(12s)-16-ethyl-12-(methoxycarbonyl)-1,10-diazatetracyclo[12.3.1.0(3),(1)(1).0?,?]octadeca-3(11),4,6,8,15-pentaen-12-yl]-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.0(1),?.0(2),?.0(1)?,(1)?]nonadeca-2(7),3,5,13-tetraene-10-carboxylate

2.3 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 1079.1 g/mol
Molecular Formula C53H66N4O20
Hydrogen Bond Donor Count10
Hydrogen Bond Acceptor Count23
Rotatable Bond Count16
Exact Mass1078.42704051 g/mol
Monoisotopic Mass1078.42704051 g/mol
Topological Polar Surface Area364 Ų
Heavy Atom Count77
Formal Charge0
Complexity1820
Isotope Atom Count0
Defined Atom Stereocenter Count11
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameVinorelbine tartrate
Drug LabelVinorelbine Tartrate Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection, USP. No preservatives or other additives are present....
Active IngredientVinorelbine tartrate
Dosage FormInjectable
RouteInjection
Strengtheq 10mg base/ml
Market StatusPrescription
CompanyBedford; Hospira; Jiangsu Hansoh Pharm; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Hikma Maple; Ebewe Pharma; Dr Reddys Labs

2 of 2  
Drug NameVinorelbine tartrate
Drug LabelVinorelbine Tartrate Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection, USP. No preservatives or other additives are present....
Active IngredientVinorelbine tartrate
Dosage FormInjectable
RouteInjection
Strengtheq 10mg base/ml
Market StatusPrescription
CompanyBedford; Hospira; Jiangsu Hansoh Pharm; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Hikma Maple; Ebewe Pharma; Dr Reddys Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Tubulin Modulators

Agents that interact with TUBULIN to inhibit or promote polymerization of MICROTUBULES. (See all compounds classified as Tubulin Modulators.)


Antineoplastic Agents, Phytogenic

Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity. (See all compounds classified as Antineoplastic Agents, Phytogenic.)


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28-Jan-2022
19-Apr-2025
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ABOUT THIS PAGE

Looking for 125317-39-7 / Vinorelbine Tartrate API manufacturers, exporters & distributors?

Vinorelbine Tartrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Vinorelbine Tartrate

Synonyms

125317-39-7, Kw 2307, Navelbine (tn), Vinorelbine ditartrate (jan), Vinorelbine bitartarate, Vinorelbine tartrate (usp)

Cas Number

125317-39-7

About Vinorelbine Tartrate

A vinca alkaloid related to VINBLASTINE that is used as a first-line treatment for NON-SMALL CELL LUNG CANCER, or for advanced or metastatic BREAST CANCER refractory to treatment with ANTHRACYCLINES.

Navelbine, Vinorelbine Manufacturers

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

Navelbine, Vinorelbine Suppliers

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

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

Navelbine, Vinorelbine USDMF

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

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

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Navelbine, Vinorelbine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Navelbine, Vinorelbine Drug Master File in Japan (Navelbine, Vinorelbine JDMF) empowers Navelbine, Vinorelbine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Navelbine, Vinorelbine JDMF during the approval evaluation for pharmaceutical products. At the time of Navelbine, Vinorelbine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Navelbine, Vinorelbine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Navelbine, Vinorelbine Drug Master File in Korea (Navelbine, Vinorelbine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Navelbine, Vinorelbine. The MFDS reviews the Navelbine, Vinorelbine KDMF as part of the drug registration process and uses the information provided in the Navelbine, Vinorelbine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Navelbine, Vinorelbine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Navelbine, Vinorelbine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Navelbine, Vinorelbine suppliers with KDMF on PharmaCompass.

Navelbine, Vinorelbine CEP

A Navelbine, Vinorelbine CEP of the European Pharmacopoeia monograph is often referred to as a Navelbine, Vinorelbine Certificate of Suitability (COS). The purpose of a Navelbine, Vinorelbine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Navelbine, Vinorelbine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Navelbine, Vinorelbine to their clients by showing that a Navelbine, Vinorelbine CEP has been issued for it. The manufacturer submits a Navelbine, Vinorelbine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Navelbine, Vinorelbine CEP holder for the record. Additionally, the data presented in the Navelbine, Vinorelbine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Navelbine, Vinorelbine DMF.

A Navelbine, Vinorelbine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Navelbine, Vinorelbine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Navelbine, Vinorelbine suppliers with CEP (COS) on PharmaCompass.

Navelbine, Vinorelbine 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 Navelbine, Vinorelbine as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Navelbine, Vinorelbine suppliers with NDC on PharmaCompass.

Navelbine, Vinorelbine GMP

Navelbine, Vinorelbine 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 Navelbine, Vinorelbine 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 Navelbine, Vinorelbine GMP manufacturer or Navelbine, Vinorelbine GMP API supplier for your needs.

Navelbine, Vinorelbine CoA

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

Navelbine, Vinorelbine CoA mostly includes findings from lab analyses of a specific batch. For each Navelbine, Vinorelbine 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.

Navelbine, Vinorelbine may be tested according to a variety of international standards, such as European Pharmacopoeia (Navelbine, Vinorelbine EP), Navelbine, Vinorelbine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Navelbine, Vinorelbine 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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