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Synopsis

Synopsis

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Chemistry

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Also known as: 57773-63-4, Triptoreline, Arvekap, (d-trp6)-gnrh, Decapeptyl, Triptorelina
Molecular Formula
C64H82N18O13
Molecular Weight
1311.4  g/mol
InChI Key
VXKHXGOKWPXYNA-PGBVPBMZSA-N

Triptorelin Pamoate
A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE with D-tryptophan substitution at residue 6.
1 2D Structure

Triptorelin Pamoate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-N-[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2R)-1-[[(2S)-1-[[(2S)-1-[(2S)-2-[(2-amino-2-oxoethyl)carbamoyl]pyrrolidin-1-yl]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]-5-oxopyrrolidine-2-carboxamide
2.1.2 InChI
InChI=1S/C64H82N18O13/c1-34(2)23-46(56(88)75-45(13-7-21-69-64(66)67)63(95)82-22-8-14-52(82)62(94)72-31-53(65)85)76-58(90)48(25-36-28-70-42-11-5-3-9-40(36)42)78-57(89)47(24-35-15-17-39(84)18-16-35)77-61(93)51(32-83)81-59(91)49(26-37-29-71-43-12-6-4-10-41(37)43)79-60(92)50(27-38-30-68-33-73-38)80-55(87)44-19-20-54(86)74-44/h3-6,9-12,15-18,28-30,33-34,44-52,70-71,83-84H,7-8,13-14,19-27,31-32H2,1-2H3,(H2,65,85)(H,68,73)(H,72,94)(H,74,86)(H,75,88)(H,76,90)(H,77,93)(H,78,89)(H,79,92)(H,80,87)(H,81,91)(H4,66,67,69)/t44-,45-,46-,47-,48+,49-,50-,51-,52-/m0/s1
2.1.3 InChI Key
VXKHXGOKWPXYNA-PGBVPBMZSA-N
2.1.4 Canonical SMILES
CC(C)CC(C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NCC(=O)N)NC(=O)C(CC2=CNC3=CC=CC=C32)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CC5=CNC6=CC=CC=C65)NC(=O)C(CC7=CN=CN7)NC(=O)C8CCC(=O)N8
2.1.5 Isomeric SMILES
CC(C)C[C@@H](C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NCC(=O)N)NC(=O)[C@@H](CC2=CNC3=CC=CC=C32)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC5=CNC6=CC=CC=C65)NC(=O)[C@H](CC7=CN=CN7)NC(=O)[C@@H]8CCC(=O)N8
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 6-d-tryptophan-luteinizing Hormone-releasing Factor (pig)

2. Ay 25650

3. Ay-25650

4. Ay25650

5. Cl 118532

6. Cl-118532

7. Cl118532

8. D-trp-6-lh-rh

9. Decapeptyl

10. Decapeptyl Depot

11. Decapeptyl Lp

12. Decapeptyl Trimestral

13. Embonate, Triptorelin

14. Gnrh, Trp(6)-

15. Lhrh, Trp(6)-

16. Lhrh, Tryptophyl(6)-

17. Pamoate, Triptorelin

18. Trelstar

19. Trimestral, Decapeptyl

20. Triptorelin Embonate

21. Triptorelin Pamoate

22. Wy 42462

23. Wy-42462

24. Wy42462

2.2.2 Depositor-Supplied Synonyms

1. 57773-63-4

2. Triptoreline

3. Arvekap

4. (d-trp6)-gnrh

5. Decapeptyl

6. Triptorelina

7. Triptorelinum

8. Trelstar

9. Triptodur

10. Diphereline

11. (6-d-tryptophan)luteinizing Hormone-releasing Hormone

12. Cl 118532

13. Cl-118532

14. Pglu-his-trp-ser-tyr-d-trp-leu-arg-pro-gly-nh2

15. Ay-25650

16. Luteinizing Hormone-releasing Factor (pig), 6-d-tryptophan

17. Cl 118,532

18. Chebi:63633

19. Wy 42462

20. Ay 25650

21. Pamorelin

22. Salvacyl

23. Trelstar Depot

24. 5-oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-tryptophyl-l-leucyl-l-arginyl-l-prolylglycinamide

25. Trelstar La

26. Luteinizing Hormone-releasing Factor (swine), 6-d-tryptophan-

27. Bim 21003

28. Wy 42422

29. Tryptorelin

30. Diferelin

31. D-tryptophan-lh-rh

32. Triptoreline [inn-french]

33. Triptorelinum [inn-latin]

34. Triptorelina [inn-spanish]

35. Trellasar

36. Moapar

37. Triptorelin [usan:inn:ban]

38. Decapeptyl Sr

39. Pamorelin La

40. Unii-9081y98w2v

41. Triptorelin (swine)

42. Wy-42462

43. D-trp6-lhrh

44. Debio-8206

45. Triptorelin (usan/inn)

46. (d-trp6)-lh-rh

47. Gtpl1177

48. Schembl5079698

49. Chembl1201334

50. Dtxsid2048375

51. Schembl22289009

52. Hms2090c17

53. Ex-a3857

54. Bim-21003

55. Akos030213249

56. 9081y98w2v

57. Cs-5745

58. Db06825

59. Ncgc00167301-01

60. Ncgc00167301-02

61. As-71149

62. Bn-52014

63. Hy-12551

64. 73t634

65. C75704

66. D06247

67. [d-trp6]-lh-rh, >=97% (hplc), Powder

68. Ab01275488-01

69. A936467

70. Pglu-his-trp-ser-tyr-d-trp-leu-arg-pro-glynh2

71. Q1992452

72. (s)-1-((3s,6s,9s,12s,15r,18s,21s)-3-((1h-imidazol-5-yl)methyl)-6,15-bis((1h-indol-3-yl)methyl)-21-(3-guanidinopropyl)-12-(4-hydroxybenzyl)-9-(hydroxymethyl)-18-isobutyl-1,4,7,10,13,16,19-heptaoxo-1-((s)-5-oxopyrrolidin-2-yl)-2,5,8,11,14,17,20-heptaazadocosan-22-oyl)-n-(2-amino-2-oxoethyl)pyrrolidine-2-carboxamide

73. Glycinamide, 5-oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-tryptophyl-l-leucyl-l-arginyl-l-prolyl-

2.3 Create Date
2008-12-10
3 Chemical and Physical Properties
Molecular Weight 1311.4 g/mol
Molecular Formula C64H82N18O13
XLogP3-0.3
Hydrogen Bond Donor Count17
Hydrogen Bond Acceptor Count15
Rotatable Bond Count33
Exact Mass1310.63087474 g/mol
Monoisotopic Mass1310.63087474 g/mol
Topological Polar Surface Area490 Ų
Heavy Atom Count95
Formal Charge0
Complexity2710
Isotope Atom Count0
Defined Atom Stereocenter Count9
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameTrelstar
PubMed HealthTriptorelin (Injection)
Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
Drug LabelTRELSTAR is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR has a milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical...
Active IngredientTriptorelin pamoate
Dosage FormInjectable
RouteIntramuscular
Strengtheq 11.25mg base/vial; eq 3.75mg base/vial; eq 22.5mg base/vial
Market StatusPrescription
CompanyWatson Labs

2 of 2  
Drug NameTrelstar
PubMed HealthTriptorelin (Injection)
Drug ClassesAntineoplastic Agent, Endocrine-Metabolic Agent
Drug LabelTRELSTAR is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR has a milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical...
Active IngredientTriptorelin pamoate
Dosage FormInjectable
RouteIntramuscular
Strengtheq 11.25mg base/vial; eq 3.75mg base/vial; eq 22.5mg base/vial
Market StatusPrescription
CompanyWatson Labs

4.2 Drug Indication

Triptorelin is indicated for the palliative treatment of advanced prostate cancer.


FDA Label


For the synchronisation of ovulation in weaned sows to enable a single fixed-time artificial insemination.


5 Pharmacology and Biochemistry
5.1 Pharmacology

The first administration of triptorelin is followed by a transient surge of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol,and testosterone. The time, peak and decline of testosterone in the body varies depending on the dose administered. This initial surge is often responsible for worsening of prostate cancer symptoms such as urethral or bladder outlet obstruction, bone pain, spinal cord injury and hematuria in the early stages. A sustained decrease in FSH and LH, and significant reduction of testicular steroidogenesis is usually seen 2-4 weeks post-initiation of therapy. This result is a reduction of serum testosterone to levels which are typically seen in surgically castrated men. Ultimately, tissues and functions that require these hormones become inactive. The effects of triptorelin can usually be reversed once the drug is discontinued.


5.2 MeSH Pharmacological Classification

Antineoplastic Agents, Hormonal

Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)


Luteolytic Agents

Chemical compounds that cause LUTEOLYSIS or degeneration of the CORPUS LUTEUM. (See all compounds classified as Luteolytic Agents.)


5.3 ATC Code

QH01CA97


L - Antineoplastic and immunomodulating agents

L02 - Endocrine therapy

L02A - Hormones and related agents

L02AE - Gonadotropin releasing hormone analogues

L02AE04 - Triptorelin


5.4 Absorption, Distribution and Excretion

Absorption

Following IV administration of triptorelin, triptorelin is completely absorbed.


Route of Elimination

Elimination of triptorelin involves both the kidneys and the liver.


Volume of Distribution

After a single IV dose of 0.5mg, the volume of distribution of triptorelin peptide in healthy males was 30 - 33L.


Clearance

In healthy male volunteers, total clearance of triptorelin was 211.9 mL/min.


5.5 Metabolism/Metabolites

The metabolism of triptorelin in humans is not well understood; however, metabolism likely does not involve hepatic enzymes such as cytochrome P450. Whether or not triptorelin affects, or how it affects other metabolizing enzymes is also poorly understood. Triptorelin has no identified metabolites.


5.6 Biological Half-Life

The pharmacokinetics of triptorelin follows a 3 compartment model. The half lives are estimated to be 6 minutes, 45 minutes, and 3 hours respectively.


5.7 Mechanism of Action

Triptorelin is a synthetic agonist analog of gonadotropin releasing hormone (GnRH). Animal studies comparing triptorelin to native GnRH found that triptorelin had 13 fold higher releasing activity for luteinizing hormone, and 21-fold higher releasing activity for follicle-stimulating hormone.


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Triptorelin Pamoate

About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...

With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide, providing a wide range of services. Over the years, Bachem has established itself as a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company is headquartered in Switzerland and has offices in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
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Triptorelin Pamoate

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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About the Company : JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao I...

JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao International airport. JIN DUN Medical Research Institute is committed to providing pharmaceutical intermediates and raw materials with the purpose of innovative drug research. Customized R&D and customized production services.
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Triptorelin

About the Company : Smaart Pharmaceutticals consciously strive for innovation through newer technologies, modern equipment available betterment of life and bring newer products for its customer. Smaa...

Smaart Pharmaceutticals consciously strive for innovation through newer technologies, modern equipment available betterment of life and bring newer products for its customer. Smaart has two state of the art manufacturing blocks. Our registered office is located at Jalgaon; which is our manufacturing facility as well. Geographically Jalgaon falls at North of Maharashtra, in the close vicinity of The famous ancient Buddhist cave temples of Ajanta; which were excavated between the 2d century BC and the 5th century AD.
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Triptorelin

About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
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API Reference Price

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07-Jan-2021
07-Jan-2021
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Regulatory Info :

Registration Country : India

Triptorelin Pamoate

Brand Name :

Dosage Form : Depot Injection

Dosage Strength : 3.75MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Regulatory Info :

Registration Country : India

Triptorelin Pamoate

Brand Name :

Dosage Form : Depot Injection

Dosage Strength : 11.25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

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  • fda
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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Regulatory Info :

Registration Country : India

Triptorelin Pamoate

Brand Name :

Dosage Form : Depot Injection

Dosage Strength : 22.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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BioProcess International
Not Confirmed

Triptorelin

Brand Name : Trelstar LA 3,75 mg

Dosage Form : POI

Dosage Strength : 3.75mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

05

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BioProcess International
Not Confirmed

Triptorelin

Brand Name : Trelstar LA 11,25 mg

Dosage Form : POI

Dosage Strength : 11.25mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

06

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BioProcess International
Not Confirmed

Triptorelin

Brand Name : Trelstar LA 22,5 mg

Dosage Form : POI

Dosage Strength : 22.5mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

TRIPTORELIN PAMOATE

Brand Name : TRIPTODUR KIT

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage Strength : EQ 22.5MG BASE/VIAL

Packaging :

Approval Date : 2017-06-29

Application Number : 208956

Regulatory Info : RX

Registration Country : USA

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08

Debiopharm

Switzerland
BioProcess International
Not Confirmed
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Debiopharm

Switzerland
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BioProcess International
Not Confirmed

Triptorelinum

Brand Name : Pamorelin LA

Dosage Form : Trockensub

Dosage Strength : 22.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

triptorelin

Brand Name : Decapeptyl

Dosage Form :

Dosage Strength :

Packaging : 7

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Country
BioProcess International
Not Confirmed
arrow

Country
arrow
BioProcess International
Not Confirmed

triptorelinembonat

Brand Name : Pamorelin

Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Dosage Strength : 22.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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FDA Orange Book

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01

AZURITY

U.S.A
BioProcess International
Not Confirmed
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AZURITY

U.S.A
arrow
BioProcess International
Not Confirmed

TRIPTORELIN PAMOATE

Brand Name : TRIPTODUR KIT

Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage Strength : EQ 22.5MG BASE/VIAL

Approval Date : 2017-06-29

Application Number : 208956

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

VERITY

Canada
BioProcess International
Not Confirmed
arrow

VERITY

Canada
arrow
BioProcess International
Not Confirmed

TRIPTORELIN PAMOATE

Brand Name : TRELSTAR

Dosage Form : INJECTABLE;INTRAMUSCULAR

Dosage Strength : EQ 3.75MG BASE/VIAL

Approval Date : 2000-06-15

Application Number : 20715

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

VERITY

Canada
BioProcess International
Not Confirmed
arrow

VERITY

Canada
arrow
BioProcess International
Not Confirmed

TRIPTORELIN PAMOATE

Brand Name : TRELSTAR

Dosage Form : INJECTABLE;INTRAMUSCULAR

Dosage Strength : EQ 11.25MG BASE/VIAL

Approval Date : 2001-06-29

Application Number : 21288

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

VERITY

Canada
BioProcess International
Not Confirmed
arrow

VERITY

Canada
arrow
BioProcess International
Not Confirmed

TRIPTORELIN PAMOATE

Brand Name : TRELSTAR

Dosage Form : INJECTABLE;INTRAMUSCULAR

Dosage Strength : EQ 22.5MG BASE/VIAL

Approval Date : 2010-03-10

Application Number : 22437

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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01

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Triptorelinum

Brand Name : Pamorelin LA

Dosage Form : Trockensub

Dosage Strength : 11.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Triptorelinum

Brand Name : Pamorelin LA

Dosage Form : Trockensub

Dosage Strength : 3.75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Triptorelinum

Brand Name : Pamorelin LA

Dosage Form : Trockensub

Dosage Strength : 22.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

FERRING SpA

Switzerland
BioProcess International
Not Confirmed
arrow

FERRING SpA

Switzerland
arrow
BioProcess International
Not Confirmed

Triptorelin

Brand Name : Gonapeptyl Depot

Dosage Form : Tryptoreline 3,75Mg 1 Unit Parenteral Use

Dosage Strength : 1 syringe IM SC 3.75 mg + 1 ampoule solv 1 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Triptorelin

Brand Name : Gonapeptyl

Dosage Form : Injection fluid, resolution

Dosage Strength : 0.1 mg/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

Ferring AG

Switzerland
BioProcess International
Not Confirmed
arrow

Ferring AG

Switzerland
arrow
BioProcess International
Not Confirmed

Triptorelini acetas hydricus

Brand Name : Decapeptyl

Dosage Form : Inj L?s

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

Institute Produits Synthèse

Country
BioProcess International
Not Confirmed
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Institute Produits Synthèse

Country
arrow
BioProcess International
Not Confirmed

triptorelinembonat

Brand Name : Pamorelin

Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Dosage Strength : 11.25 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Institute Produits Synthèse

Country
BioProcess International
Not Confirmed
arrow

Institute Produits Synthèse

Country
arrow
BioProcess International
Not Confirmed

triptorelinembonat

Brand Name : Pamorelin

Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Dosage Strength : 22.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

Institute Produits Synthèse

Country
BioProcess International
Not Confirmed
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Institute Produits Synthèse

Country
arrow
BioProcess International
Not Confirmed

triptorelinembonat

Brand Name : Pamorelin

Dosage Form : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Dosage Strength : 3.75 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Institut Produits Synthèse (IPSEN) AB

Country
BioProcess International
Not Confirmed
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Institut Produits Synthèse (IPSEN) AB

Country
arrow
BioProcess International
Not Confirmed

Triptorelin

Brand Name : Pamorelin

Dosage Form : Powder and liquid to depot injection fluid, suspension

Dosage Strength : 11.25 mg

Packaging : Set

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Listed Dossiers

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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Triptorelin Pamoate

Brand Name :

Dosage Form : Depot Injection

Dosage Strength : 3.75MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Triptorelin Pamoate

Dosage : Depot Injection

Dosage Strength : 3.75MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Omgene Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Triptorelin Pamoate

Brand Name :

Dosage Form : Depot Injection

Dosage Strength : 11.25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Triptorelin Pamoate

Dosage : Depot Injection

Dosage Strength : 11.25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Omgene Company Banner

03

  • fda
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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Triptorelin Pamoate

Brand Name :

Dosage Form : Depot Injection

Dosage Strength : 22.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

03

  • fda
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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Triptorelin Pamoate

Dosage : Depot Injection

Dosage Strength : 22.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Omgene Company Banner

04

Pluviaendo

Turkey
BioProcess International
Not Confirmed
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Pluviaendo

Turkey
arrow
BioProcess International
Not Confirmed

Triptorelin Pamoate

Brand Name :

Dosage Form : Pre-Filled Syringe

Dosage Strength : 11.25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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04

Pluviaendo

Turkey
BioProcess International
Not Confirmed
arrow

Pluviaendo

Turkey
arrow
BioProcess International
Not Confirmed

Triptorelin Pamoate

Dosage : Pre-Filled Syringe

Dosage Strength : 11.25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Turkey

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Triptorelin

Brand Name : Microrelin

Dosage Form : Injection

Dosage Strength : 3.75MG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Iran

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Triptorelin

Dosage : Injection

Dosage Strength : 3.75MG/2ML

Brand Name : Microrelin

Approval Date :

Application Number :

Registration Country : Iran

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06

BioProcess International
Not Confirmed
arrow
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BioProcess International
Not Confirmed

Triptorelin

Brand Name :

Dosage Form : Injection

Dosage Strength : 11.25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Iran

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06

BioProcess International
Not Confirmed
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arrow
BioProcess International
Not Confirmed

Triptorelin

Dosage : Injection

Dosage Strength : 11.25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Iran

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07

BioProcess International
Not Confirmed
arrow
arrow
BioProcess International
Not Confirmed

Triptorelin

Brand Name :

Dosage Form : Injection

Dosage Strength : 22.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Iran

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07

BioProcess International
Not Confirmed
arrow
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BioProcess International
Not Confirmed

Triptorelin

Dosage : Injection

Dosage Strength : 22.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Iran

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08

BioProcess International
Not Confirmed
arrow
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BioProcess International
Not Confirmed

Triptorelin

Brand Name :

Dosage Form : Injection

Dosage Strength :

Packaging : Three Months Depot

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

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08

BioProcess International
Not Confirmed
arrow
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BioProcess International
Not Confirmed

Triptorelin

Dosage : Injection

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : Iran

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 3.75MG...DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 3.75MG BASE/VIAL

USFDA APPLICATION NUMBER - 20715

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DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 11.25M...DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 11.25MG BASE/VIAL

USFDA APPLICATION NUMBER - 21288

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DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 22.5MG...DOSAGE - INJECTABLE;INTRAMUSCULAR - EQ 22.5MG BASE/VIAL

USFDA APPLICATION NUMBER - 22437

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