Synopsis
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1. Pm 01183
2. Pm-01183
3. Pm01183
1. 497871-47-3
2. Pm01183
3. Tryptamicidin
4. Zepzelca
5. Pm-01183
6. Pm-1183
7. 2cn60tn6zs
8. Pm 01183
9. Pm1183
10. [(1r,2r,3r,11s,12s,14r,26r)-5,12-dihydroxy-6,6'-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1'-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22-yl] Acetate
11. Zepsyre
12. Lurbinectedin [inn]
13. Unii-2cn60tn6zs
14. Lurbinectedin [mi]
15. Lurbinectedin [usan:inn]
16. Lurbinectedin [usan]
17. Lurbinectedin [who-dd]
18. Chembl4297516
19. Schembl16152477
20. Gtpl10681
21. Dtxsid30198065
22. Lurbinectedin [orange Book]
23. Ex-a4316
24. Who 9397
25. Nsc826275
26. S9603
27. At22223
28. Cs-6323
29. Db12674
30. Nsc-826275
31. Hy-16293
32. J3.531.659k
33. J3.652.626b
34. Pm01183;pm-1183;ly-01017;ryptamicidin
35. Q27254568
36. (1'r,6r,6ar,7r,13s,14s,16r)-8,14-dihydroxy-6',9-dimethoxy-4,10,23-trimethyl-19-oxo-2',3',4',6,7,9',12,13,14,16-decahydro-6ahspiro(7,13-azano-6,16-(epithiopropanooxymethano)(1,3)dioxolo(7,8)isoquinolino(3,2-b)(3)benzazocine-20,1'-pyrido(3,4-b)indol)-5-yl Acetate
37. [(1r,2r,3r,11s,12s,14r,26r)-5,12-dihydroxy-6,6'-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1'-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22
38. Spiro(6,16-(epithiopropanoxymethano)-7,13-imino-12h-1,3-dioxolo(7,8)isoquino(3,2-b)(3)benzazocine-20,1'-(1h)pyrido(3,4-b)indol)-19-one, 5-(acetyloxy)-2',3',4',6,6a,7,9',13,14,16-decahydro-8,14-dihydroxy-6',9-dimethoxy-4,10,23-trimethyl-, (1'r,6r,6ar,7r,13s,14s,16r)-
Molecular Weight | 784.9 g/mol |
---|---|
Molecular Formula | C41H44N4O10S |
XLogP3 | 3.9 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 4 |
Exact Mass | 784.27781479 g/mol |
Monoisotopic Mass | 784.27781479 g/mol |
Topological Polar Surface Area | 190 Ų |
Heavy Atom Count | 56 |
Formal Charge | 0 |
Complexity | 1530 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 7 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Lurbinectedin is indicated for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Treatment of small cell lung cancer
Lurbinectedin exerts its chemotherapeutic activity by covalently binding to DNA, resulting in double-strand DNA breaks and subsequent cell death. Lurbinectedin has been associated with myelosuppression, and patients receiving therapy with this agent should be closely monitored for evidence of cytopenias. Prior to beginning therapy, ensure baseline neutrophil counts are >1,500 cells/mm3 and platelet counts are >100,000/mm3. The supplementary use of granulocyte colony-stimulating factor (G-CSF) should be considered if the neutrophil count falls below 500 cells/mm3. Lurbinectedin has also been associated with hepatotoxicity. Monitor liver function tests at baseline and regular intervals throughout therapy, and consider holding, reducing, or permanently discontinuing therapy based on the severity of observed hepatotoxicity.
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XX - Other antineoplastic agents
L01XX69 - Lurbinectedin
Absorption
Following intravenous administration, the Cmax and AUC0-inf were 107 g/L and 551 g*h/L, respectively. No accumulation between dosing intervals (every 3 weeks) has been observed. No significant differences in absorption were found between special populations (e.g. based on age, sex, ethnicity, etc.), but lurbinectedin has not been studied in the setting of severe renal impairment or moderate/severe hepatic impairment.
Route of Elimination
Approximately 89% of a given dose is recovered in the feces (<0.2% unchanged) and 6% in the urine (1% unchanged).
Volume of Distribution
The steady-state volume of distribution of lurbinectedin is 504 L.
Clearance
The total plasma clearance of lurbinectedin is approximately 11 L/h.
Lurbinectedin is metabolized primarily by CYP3A4 _in vitro_, though specific data regarding its biotransformation are lacking. An N-desmethylated metabolite has been identified in canine subjects.
The terminal half-life of lurbinectedin is 51 hours.
Lurbinectedin is a DNA alkylating agent. It covalently binds to guanine residues in the DNA minor groove, forming adducts that bend the DNA helix towards the major groove. This process triggers a cascade of events that affect the activity of transcription factors and impairs DNA repair pathways, ultimately leading to double-strand DNA breaks and eventual cell death. Additional mechanism(s) of action include inhibition of RNA-polymerase-II activity, inactivation of Ewing Sarcoma Oncoprotein (EWS-FL11) via nuclear redistribution, and the inhibition of human monocyte activity and macrophage infiltration into tumor tissue.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-28
Pay. Date : 2024-01-16
DMF Number : 39171
Submission : 2024-01-13
Status : Active
Type : II
NDC Package Code : 42973-353
Start Marketing Date : 2023-05-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-08
Pay. Date : 2024-04-18
DMF Number : 39672
Submission : 2024-03-28
Status : Active
Type : II
NDC Package Code : 54893-0508
Start Marketing Date : 2024-03-28
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 : 39228
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39620
Submission : 2024-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-28
Pay. Date : 2024-01-16
DMF Number : 39171
Submission : 2024-01-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39228
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-08
Pay. Date : 2024-04-18
DMF Number : 39672
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39620
Submission : 2024-09-06
Status : Active
Type : II
NDC Package Code : 42973-353
Start Marketing Date : 2023-05-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 69112-102
Start Marketing Date : 2020-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (4mg/8mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 54893-0508
Start Marketing Date : 2024-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 83703-583
Start Marketing Date : 2020-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (0.5mg/mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...
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About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...
About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special gener...
About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...
About the Company : Haorui, established in 1997, is a manufacturer and supplier of APIs, intermediates, veterinary and food additives. Meanwhile, it is assisting global pharmaceutical companies to get...
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Details:
Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq) is being investigated as a maintenance treatment for adults with extensive-stage small cell lung cancer.
Lead Product(s): Lurbinectedin,Atezolizumab
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Phase IIIProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 15, 2024
Lead Product(s) : Lurbinectedin,Atezolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Jazz Pharma’s Zepzelca® Combo Shows Survival Benefit in Lung Cancer
Details : Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq) is being investigated as a maintenance treatment for adults with extensive-stage small cell lung cancer.
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
October 15, 2024
Details:
Zepzelca (lurbinectedin) is a DNA-negative allosteric modulator. It is approved for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Lead Product(s): Lurbinectedin
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: PharmaMar
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 12, 2023
Lead Product(s) : Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : PharmaMar
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zepzelca (lurbinectedin) is a DNA-negative allosteric modulator. It is approved for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
December 12, 2023
Details:
Zepzelca (lurbinectedin) inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor.
Lead Product(s): Lurbinectedin
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 03, 2023
Lead Product(s) : Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zepzelca (lurbinectedin) inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor.
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
August 03, 2023
Details:
Zepzelca (lurbinectedin), is an alkylating drug that binds guanine residues within DNA, triggers a cascade of events that can affect the activity of DNA binding proteins, and DNA repair pathways, resulting in disruption of cell cycle and eventual cell death.
Lead Product(s): Lurbinectedin
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2022
Lead Product(s) : Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zepzelca (lurbinectedin), is an alkylating drug that binds guanine residues within DNA, triggers a cascade of events that can affect the activity of DNA binding proteins, and DNA repair pathways, resulting in disruption of cell cycle and eventual cell de...
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
December 05, 2022
Details:
Zepzelca (lurbinectedin) is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of cell cycle.
Lead Product(s): Lurbinectedin,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Phase IIIProduct Type: Cytotoxic Drug
Sponsor: PharmaMar
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 26, 2022
Lead Product(s) : Lurbinectedin,Doxorubicin Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : PharmaMar
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zepzelca (lurbinectedin) is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in dis...
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
October 26, 2022
Details:
Cosela (trilaciclib), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
Lead Product(s): Trilaciclib,Lurbinectedin
Therapeutic Area: Oncology Brand Name: Cosela
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 26, 2022
Lead Product(s) : Trilaciclib,Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cosela (trilaciclib), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
Product Name : Cosela
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 26, 2022
Details:
CDK12 inhibitor demonstrates strong anti-tumor activity as single agent and in combination with a DNA damaging agent and a PARP inhibitor in models of breast, lung, and ovarian cancer.
Lead Product(s): SY-5609,Lurbinectedin,Olaparib
Therapeutic Area: Oncology Brand Name: SY-5609
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2022
Lead Product(s) : SY-5609,Lurbinectedin,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CDK12 inhibitor demonstrates strong anti-tumor activity as single agent and in combination with a DNA damaging agent and a PARP inhibitor in models of breast, lung, and ovarian cancer.
Product Name : SY-5609
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 04, 2022
Details:
Zepzelca (lurbinectedin) is a DNA-negative allosteric modulator. It is approved for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Lead Product(s): Lurbinectedin
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: PharmaMar
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 17, 2022
Lead Product(s) : Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : PharmaMar
Deal Size : Inapplicable
Deal Type : Inapplicable
Luye Pharma’s Innovative Drug Lurbinectedin Approved for Urgent Clinical Use in Hainan
Details : Zepzelca (lurbinectedin) is a DNA-negative allosteric modulator. It is approved for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 17, 2022
Details:
Zepzelca (lurbinectedin), is an alkylating drug that binds guanine residues within DNA, triggers a cascade of events that can affect activity of DNA binding proteins, including some transcription factors resulting in disruption of cell cycle and eventual cell death.
Lead Product(s): Lurbinectedin
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 24, 2022
Lead Product(s) : Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zepzelca (lurbinectedin), is an alkylating drug that binds guanine residues within DNA, triggers a cascade of events that can affect activity of DNA binding proteins, including some transcription factors resulting in disruption of cell cycle and eventual...
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
March 24, 2022
Details:
Eczacıbaşı will pursue the marketing authorization in Turkey and will have the right to commercialize the Zepzelca (Lurbinectedin), on an exclusive basis, upon approval. Lurbinectedin was granted accelerated approval by FDA for relapsed metastatic Small Cell Lung Cancer.
Lead Product(s): Lurbinectedin
Therapeutic Area: Oncology Brand Name: Zepzelca
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Eczacıbaşı Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 22, 2021
Lead Product(s) : Lurbinectedin
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eczacıbaşı Group
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Eczacıbaşı will pursue the marketing authorization in Turkey and will have the right to commercialize the Zepzelca (Lurbinectedin), on an exclusive basis, upon approval. Lurbinectedin was granted accelerated approval by FDA for relapsed metastatic Sma...
Product Name : Zepzelca
Product Type : Cytotoxic Drug
Upfront Cash : Undisclosed
December 22, 2021
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEPZELCA
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 4MG/VIAL
Packaging :
Approval Date : 2020-06-15
Application Number : 213702
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ZEPZELCA
Dosage Form : POWDER
Dosage Strength : 4MG/VIAL
Packaging :
Approval Date :
Application Number : 2520834
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Intravenous Powder
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zepzelca
Dosage Form : Dry Sub
Dosage Strength : 4mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
RLD : Yes
TE Code :
Brand Name : ZEPZELCA
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 4MG/VIAL
Approval Date : 2020-06-15
Application Number : 213702
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zepzelca
Dosage Form : Dry Sub
Dosage Strength : 4mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ZEPZELCA
Dosage Form : POWDER
Dosage Strength : 4MG/VIAL
Packaging :
Approval Date :
Application Number : 2520834
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Intravenous Powder
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Intravenous Powder
Dosage Strength : 4MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
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Global Sales Information
Company :
Lurbinectedin
Drug Cost (USD) : 1,637,629
Year : 2022
Prescribers : 40
Prescriptions : 120
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Lurbinectedin
Drug Cost (USD) : 1,211,475
Year : 2021
Prescribers : 29
Prescriptions : 87
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Dosage Form : Dry Sub
Dosage Strength : 4mg
Price Per Pack (Euro) : 5512.5
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 90
2019 Revenue in Millions : 0
Growth (%) : New Launch
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 247
2020 Revenue in Millions : 90
Growth (%) : 173
Main Therapeutic Indication : Oncology
Currency : USD
2022 Revenue in Millions : 270
2021 Revenue in Millions : 247
Growth (%) : 9
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 290
2022 Revenue in Millions : 270
Growth (%) : 7
Market Place
Reply
01 Mar 2025
Reply
29 Dec 2021
Reply
15 Jul 2021
Patents & EXCLUSIVITIES
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-06-15
Application Number : 213702
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-304
Exclusivity Expiration Date : 2027-06-15
Application Number : 213702
Product Number : 1
Exclusivity Details :
ABOUT THIS PAGE
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PharmaCompass offers a list of Lurbinectedin 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 Lurbinectedin manufacturer or Lurbinectedin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lurbinectedin manufacturer or Lurbinectedin supplier.
PharmaCompass also assists you with knowing the Lurbinectedin API Price utilized in the formulation of products. Lurbinectedin API Price is not always fixed or binding as the Lurbinectedin Price is obtained through a variety of data sources. The Lurbinectedin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lurbinectedin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurbinectedin, including repackagers and relabelers. The FDA regulates Lurbinectedin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurbinectedin 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 Lurbinectedin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurbinectedin supplier is an individual or a company that provides Lurbinectedin active pharmaceutical ingredient (API) or Lurbinectedin finished formulations upon request. The Lurbinectedin suppliers may include Lurbinectedin API manufacturers, exporters, distributors and traders.
click here to find a list of Lurbinectedin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lurbinectedin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurbinectedin active pharmaceutical ingredient (API) in detail. Different forms of Lurbinectedin DMFs exist exist since differing nations have different regulations, such as Lurbinectedin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lurbinectedin DMF submitted to regulatory agencies in the US is known as a USDMF. Lurbinectedin USDMF includes data on Lurbinectedin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurbinectedin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lurbinectedin 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 Lurbinectedin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lurbinectedin 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 Lurbinectedin 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 Lurbinectedin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lurbinectedin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lurbinectedin suppliers with NDC on PharmaCompass.
Lurbinectedin 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 Lurbinectedin 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 Lurbinectedin GMP manufacturer or Lurbinectedin GMP API supplier for your needs.
A Lurbinectedin CoA (Certificate of Analysis) is a formal document that attests to Lurbinectedin's compliance with Lurbinectedin specifications and serves as a tool for batch-level quality control.
Lurbinectedin CoA mostly includes findings from lab analyses of a specific batch. For each Lurbinectedin 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.
Lurbinectedin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lurbinectedin EP), Lurbinectedin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lurbinectedin USP).