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Lanreotide Acetate

bachem lanreotide acetate

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ChemWerth Lanreotide Acetate

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xyz-pharma-m-2024-10-07

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Aspen API Fluphenazine Lanreotide Acetate

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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xyz-pharma-m-2024-10-07

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 8 USDMF, 4 NDC API, 15 Listed Suppliers, $ API Reference Price

20 API Suppliers
8 USDMF
4 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

100 FDF Dossiers, 9 FDA Orange Book, 52 Europe, 3 Canada, 24 Australia, 3 South Africa, 9 Listed Dossiers

100 FDF Dossiers
9 FDA Orange Book
52 Europe
3 Canada
24 Australia
3 South Africa
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML), SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML), SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML), SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML), SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML), SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

drugProductComposition
SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 24 Finished Drug Prices, 10 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
24 Finished Drug Prices
10 Annual Reports

MARKET PLACE

4 APIs, 5 FDF Dossiers

marketPlace
4 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Exclusivities, 6 Health Canada Patents

patents
3 US Exclusivities
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 Others

otherSolutions
3 Others

Bachem Lanreotide Acetate

Synopsis

ACTIVE PHARMA INGREDIENTS

20

API Suppliers

8

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

0

EU WC

0

KDMF

4

NDC API

0

VMF

15

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 439,409

MARKET PLACE

4

API

5

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

100

FDF Dossiers

9

FDA Orange Book

FDA (Orange Book)

52

Europe

3

Canada

24

Australia

3

South Africa

9

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

3

Others

PATENTS & EXCLUSIVITIES

0

US Patents

3

US Exclusivities

6

Health Canada Patents

DIGITAL CONTENT

2

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

18

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

51,305,967

Annual Reports (USD Million)

9,023

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Somatuline lp, Lanreotide (acetate), Bim-23014c, Ipstyl, Somatuline, Somatuline autogel

Molecular Formula

C₅₆H₇₃N₁₁O₁₂S₂

Molecular Weight

1156.4 g/mol

InChI Key

DEXPIBGCLCPUHE-UISHROKMSA-N

Lanreotide Acetate

1 2D Structure

Lanreotide Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

acetic acid;(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-N-[(2S,3R)-1-amino-3-hydroxy-1-oxobutan-2-yl]-19-[[(2R)-2-amino-3-naphthalen-2-ylpropanoyl]amino]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-7-propan-2-yl-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide

2.1.2 InChI

InChI=1S/C54H69N11O10S2.C2H4O2/c1-29(2)45-54(75)63-44(53(74)65-46(30(3)66)47(57)68)28-77-76-27-43(62-48(69)38(56)23-32-15-18-33-10-4-5-11-34(33)22-32)52(73)60-41(24-31-16-19-36(67)20-17-31)50(71)61-42(25-35-26-58-39-13-7-6-12-37(35)39)51(72)59-40(49(70)64-45)14-8-9-21-55;1-2(3)4/h4-7,10-13,15-20,22,26,29-30,38,40-46,58,66-67H,8-9,14,21,23-25,27-28,55-56H2,1-3H3,(H2,57,68)(H,59,72)(H,60,73)(H,61,71)(H,62,69)(H,63,75)(H,64,70)(H,65,74);1H3,(H,3,4)/t30-,38-,40+,41+,42-,43+,44+,45+,46+;/m1./s1

2.1.3 InChI Key

DEXPIBGCLCPUHE-UISHROKMSA-N

2.1.4 Canonical SMILES

CC(C)C1C(=O)NC(CSSCC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N1)CCCCN)CC2=CNC3=CC=CC=C32)CC4=CC=C(C=C4)O)NC(=O)C(CC5=CC6=CC=CC=C6C=C5)N)C(=O)NC(C(C)O)C(=O)N.CC(=O)O

2.1.5 Isomeric SMILES

C[C@H]([C@@H](C(=O)N)NC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)C(C)C)CCCCN)CC2=CNC3=CC=CC=C32)CC4=CC=C(C=C4)O)NC(=O)[C@@H](CC5=CC6=CC=CC=C6C=C5)N)O.CC(=O)O

2.2 Synonyms

2.2.1 MeSH Synonyms

1. 188re-lanreotide

2. 2-naphthylalanyl-cyclo(cysteinyl-tyrosyl-tryptophyl-lysyl-valyl-cysteinyl)-threoninamide

3. 3-(2-naphthyl)-d-ala-cys-tyr-d-trp-lys-val-cys-thr-nh2

4. 3-(2-naphthyl)alanyl-cystinyl-tyrosyl-tryptophyl-lysyl-valyl-cystinyl-threonine Amide

5. Angiopeptin

6. Bim 23014

7. Bim 23014 C

8. Bim 23014c

9. Bim-23014

10. Bim-23014 C

11. D-nal-cys-tyr-trp-lys-val-cys-thr-nh2

12. Dc 13-116

13. Dc-13-116

14. Dc13-116

15. L-threoninamide, 3-(2-naphthalenyl)-d-alanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-valyl-l-cysteinyl-, Cyclic (2-7)-disulfide

16. Lanreotide

17. Lanreotide Acetate

18. Lanreotide-sr

19. Nal-cyclo(cys-tyr-trp-lys-val-cys)-thr-nh2

20. Nal-cyclo(cys-tyr-trp-lys-val-cys)thr-nh2

21. Naphthalenyl-cyclo(cysteinyl-tyrosyl-tryptophyl-lysyl-valyl-cysteinyl)threoninamide

22. Naphthyl-cyclo(cys-tyr-trp-lys-val-cys)thr-nh2

23. Somatulin

24. Somatulina

25. Somatuline

2.2.2 Depositor-Supplied Synonyms

1. Somatuline Lp

2. Lanreotide (acetate)

3. Bim-23014c

4. Ipstyl

5. Somatuline

6. Somatuline Autogel

7. 2378114-72-6

8. Angiopeptin Acetate

9. Somatulina

10. Somatuline La

11. Acetic Acid;(4r,7s,10s,13r,16s,19r)-10-(4-aminobutyl)-n-[(2s,3r)-1-amino-3-hydroxy-1-oxobutan-2-yl]-19-[[(2r)-2-amino-3-naphthalen-2-ylpropanoyl]amino]-16-[(4-hydroxyphenyl)methyl]-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-7-propan-2-yl-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide

12. Chembl1201184

13. Hy-p1959a

14. Itm-014

15. Mfcd00873576

16. Bn-52030

17. Dc13-116

18. Cs-0113779

19. P1088

2.3 Create Date

2006-07-28

3 Chemical and Physical Properties

Molecular Formula	C₅₆H₇₃N₁₁O₁₂S₂
Molecular Weight	1156.4 g/mol
Hydrogen Bond Donor Count	14
Hydrogen Bond Acceptor Count	16
Rotatable Bond Count	17
Exact Mass	1155.48815915 g/mol
Monoisotopic Mass	1155.48815915 g/mol
Topological Polar Surface Area	443 Å²
Heavy Atom Count	81
Formal Charge	0
Complexity	2030
Isotope Atom Count	0
Defined Atom Stereocenter Count	9
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Somatuline depot
PubMed Health	Lanreotide (Subcutaneous)
Drug Classes	Endocrine-Metabolic Agent
Drug Label	Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg is a prolonged-release formulation for deep subcutaneous injection containing the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occ...
Active Ingredient	Lanreotide acetate
Dosage Form	Injectable
Route	Subcutaneous
Strength	eq 90mg base; eq 120mg base; eq 60mg base
Market Status	Prescription
Company	Ipsen Pharma

2 of 2
Drug Name	Somatuline depot
PubMed Health	Lanreotide (Subcutaneous)
Drug Classes	Endocrine-Metabolic Agent
Drug Label	Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg is a prolonged-release formulation for deep subcutaneous injection containing the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occ...
Active Ingredient	Lanreotide acetate
Dosage Form	Injectable
Route	Subcutaneous
Strength	eq 90mg base; eq 120mg base; eq 60mg base
Market Status	Prescription
Company	Ipsen Pharma

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

API SUPPLIERS

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USDMF

01

Bachem Americas Inc

Switzerland

Pharma Manufacturing 2024

Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

Contact Supplier

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Switzerland

Digital Content

Lanreotide Acetate

GDUFA

DMF Review : Complete

Rev. Date : 2020-04-03

Pay. Date : 2019-02-01

DMF Number : 33336

Submission : 2019-02-08

Status : Active

Type : II

Bachem company banner

Product Web Link

Digital Content

02

Dr Reddys Laboratories Ltd

India

CPhI India 2024

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

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Contact Supplier

India

Digital Content

Lanreotide Acetate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39768

Submission : 2024-06-28

Status : Active

Type : II

Dr Reddy Company Banner

Product Web Link

Digital Content

03

Alp Pharm Beijing Co Ltd

China

BioFlorida Conference

Not Confirmed

04

Bcn Peptides Sa

Spain

BioFlorida Conference

Not Confirmed

05

Chengdu Shengnuo Biopharm Co Ltd

China

BioFlorida Conference

Not Confirmed

06

Ipsen Manufacturing Ireland Ltd

France

BioFlorida Conference

Not Confirmed

07

Sinopep-allsino Biopharmaceutical Co...

China

BioFlorida Conference

Not Confirmed

08

Sun Pharmaceutical Industries Ltd

India

BioFlorida Conference

Not Confirmed

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Listed Suppliers

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BAS...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

USFDA APPLICATION NUMBER - 215395

DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

USFDA APPLICATION NUMBER - 215395

DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

USFDA APPLICATION NUMBER - 215395

DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BAS...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

USFDA APPLICATION NUMBER - 22074

DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

USFDA APPLICATION NUMBER - 22074

DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

USFDA APPLICATION NUMBER - 22074

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US Medicaid Prescriptions

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REF. STANDARDS & IMPURITIES

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