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Diphereline

bachem Triptorelin

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Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

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xyz-pharma-m-2025-01-27

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Omgene Triptorelin

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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xyz-pharma-m-2025-01-20

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 3 USDMF, 1 EU WC, 10 NDC API, 8 Listed Suppliers, $ API Reference Price

11 API Suppliers
3 USDMF
1 EU WC
10 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

38 FDF Dossiers, 4 FDA Orange Book, 18 Europe, 3 Canada, 4 Australia, 4 South Africa, 5 Listed Dossiers

38 FDF Dossiers
4 FDA Orange Book
18 Europe
3 Canada
4 Australia
4 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAMUSCULAR - EQ 3.75MG BASE/VIAL, INJECTABLE;INTRAMUSCULAR - EQ 11.25MG BASE/VIAL, INJECTABLE;INTRAMUSCULAR - EQ 22.5MG BASE/VIAL

drugProductComposition
INJECTABLE;INTRAMUSCULAR - EQ 3.75MG BASE/VIAL
INJECTABLE;INTRAMUSCULAR - EQ 11.25MG BASE/VIAL
INJECTABLE;INTRAMUSCULAR - EQ 22.5MG BASE/VIAL

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 12 SPI Pharma, 1 DKSH, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Actylis, 2 BASF, 5 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 1 Kima Chemical, 5 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pluviaendo, 3 Roquette, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 Sigachi Industries, 1 The Dow Chemical Company

EXCIPIENTS BY APPLICATIONS

20 Fillers, Diluents & Binders, 13 Solubilizers, 10 Chewable & Orodispersible Aids, 10 Direct Compression, 9 Thickeners and Stabilizers, 9 Parenteral, 9 Taste Masking, 5 Rheology Modifiers, 5 Co-Processed Excipients, 4 Disintegrants & Superdisintegrants, 3 Film Formers & Plasticizers, 3 Granulation, 3 Topical, 3 Emulsifying Agents, 2 Coating Systems & Additives, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents

excipientsByApplications
20 Fillers, Diluents & Binders
13 Solubilizers
10 Chewable & Orodispersible Aids
10 Direct Compression
9 Thickeners and Stabilizers
9 Parenteral
9 Taste Masking
5 Rheology Modifiers
5 Co-Processed Excipients
4 Disintegrants & Superdisintegrants
3 Film Formers & Plasticizers
3 Granulation
3 Topical
3 Emulsifying Agents
2 Coating Systems & Additives
2 API Stability Enhancers
2 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 14 Finished Drug Prices, 10 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
14 Finished Drug Prices
10 Annual Reports

MARKET PLACE

3 APIs, 2 FDF Dossiers

marketPlace
3 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 1 US Exclusivities, 3 Health Canada Patents

patents
2 US Patents
1 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

otherSolutions
4 Others

Bachem Triptorelin

Synopsis

ACTIVE PHARMA INGREDIENTS

11

API Suppliers

3

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

1

EU WC

0

KDMF

10

NDC API

0

VMF

8

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 209,299

MARKET PLACE

3

API

2

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

38

FDF Dossiers

4

FDA Orange Book

FDA (Orange Book)

18

Europe

3

Canada

4

Australia

4

South Africa

5

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

4

Others

PATENTS & EXCLUSIVITIES

2

US Patents

1

US Exclusivities

3

Health Canada Patents

DIGITAL CONTENT

2

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

13

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

15,044,528

Annual Reports (USD Million)

4,148

Finished Drug Prices

53 RELATED EXCIPIENT COMPANIES

112EXCIPIENTS BY APPLICATIONS

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 Formula	C₆₄H₈₂N₁₈O₁₃
Molecular Weight	1311.4 g/mol
XLogP3	-0.3
Hydrogen Bond Donor Count	17
Hydrogen Bond Acceptor Count	15
Rotatable Bond Count	33
Exact Mass	1310.63087474 g/mol
Monoisotopic Mass	1310.63087474 g/mol
Topological Polar Surface Area	490 Å²
Heavy Atom Count	95
Formal Charge	0
Complexity	2710
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	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Trelstar
PubMed Health	Triptorelin (Injection)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	TRELSTAR 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 Ingredient	Triptorelin pamoate
Dosage Form	Injectable
Route	Intramuscular
Strength	eq 11.25mg base/vial; eq 3.75mg base/vial; eq 22.5mg base/vial
Market Status	Prescription
Company	Watson Labs

2 of 2
Drug Name	Trelstar
PubMed Health	Triptorelin (Injection)
Drug Classes	Antineoplastic Agent, Endocrine-Metabolic Agent
Drug Label	TRELSTAR 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 Ingredient	Triptorelin pamoate
Dosage Form	Injectable
Route	Intramuscular
Strength	eq 11.25mg base/vial; eq 3.75mg base/vial; eq 22.5mg base/vial
Market Status	Prescription
Company	Watson 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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NDC API

01

Bachem AG

Switzerland

RNA Therapeutics

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

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Switzerland

Digital Content

TRIPTORELIN PAMOATE

NDC Package Code : 55463-0006

Start Marketing Date : 2006-06-21

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

Bachem company banner

Product Web Link

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02

Debiopharm Research & Manufacturing...

Switzerland

BIO CEO & Investor

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Debiopharm Research & Manufacturing...

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05

Debiopharm Research & Manufacturing...

Switzerland

BIO CEO & Investor

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06

PolyPeptide Laboratories Private Li...

Switzerland

BIO CEO & Investor

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07

Synergy Health AST, LLC

U.S.A

BIO CEO & Investor

Not Confirmed

08

Synergy Health AST, LLC

U.S.A

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09

Synergy Health AST, LLC

U.S.A

BIO CEO & Investor

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10

Synergy Health AST, Inc

U.S.A

BIO CEO & Investor

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API Reference Price

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LTD","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"470000","totalValueFC":"11889.7","currency":"USD","unitRateINR":"39527000","date":"19-Jan-2024","totalValueINR":"988175","totalValueInUsd":"11889.7","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"9728108","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.69 12TH STREET HANGZHOU ECONOMIC& TECHNOLOGICAL DEVELOPMENT ZONESDNF China","customerAddress":"101, SITARAM MANSION,"}]

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

Drugs in Development

01

Aspen Pharmacare Holdings

South Africa

RNA Therapeutics

Not Confirmed

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Lead Product(s) : Triptorelin Pamoate

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Debiopharm

Deal Size : Undisclosed

Deal Type : Partnership

Debiopharm And Aspen Partner To Launch Prostate Cancer Drug Trelstar® In South Africa

Details : Debiopharm to enter into this new alliance with Aspen, a well-established and trusted pharmaceutical partner for the commercialization of Trelstar® in South Africa and recognize the therapeutic benefits that Trelstar® could bring to prostate cancer pat...

Product Name : Trelstar

Product Type : Peptide

Upfront Cash : Undisclosed

February 01, 2022

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02

Foresee Pharmaceuticals

U.S.A

BIO CEO & Investor

Not Confirmed

03

Debiopharm

Switzerland

BIO CEO & Investor

Not Confirmed

04

Dexa Medica

Indonesia

BIO CEO & Investor

Not Confirmed

05

Debiopharm

Switzerland

BIO CEO & Investor

Not Confirmed

06

Debiopharm

Switzerland

BIO CEO & Investor

Not Confirmed

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FDF Dossiers

01

Aspen Pharmacare Holdings

South Africa

RNA Therapeutics

Not Confirmed

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South Africa

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

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

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02

Aspen Pharmacare Holdings

South Africa

RNA Therapeutics

Not Confirmed

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South Africa

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

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

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Product Web Link

Digital Content

Corporate PDF

03

Aspen Pharmacare Holdings

South Africa

BIO CEO & Investor

Not Confirmed

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Contact Supplier

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South Africa

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

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

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04

Debiopharm

Switzerland

RNA Therapeutics

Not Confirmed

05

Debiopharm

Switzerland

RNA Therapeutics

Not Confirmed

06

Ferring Pharmaceuticals

Switzerland

RNA Therapeutics

Not Confirmed

07

Ipsen

France

RNA Therapeutics

Not Confirmed

08

Ipsen

France

RNA Therapeutics

Not Confirmed

09

Country

BIO CEO & Investor

Not Confirmed

10

Country

RNA Therapeutics

Not Confirmed

Only 10 entries up to this point, click to access all

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FDA Orange Book

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Europe

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South Africa

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Listed Dossiers

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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

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

USFDA APPLICATION NUMBER - 21288

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

USFDA APPLICATION NUMBER - 22437

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US Medicaid Prescriptions

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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

Diphereline Manufacturers

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

Diphereline Suppliers

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

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

Diphereline USDMF

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

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

click here to find a list of Diphereline suppliers with USDMF on PharmaCompass.

Diphereline WC

A Diphereline written confirmation (Diphereline WC) is an official document issued by a regulatory agency to a Diphereline manufacturer, verifying that the manufacturing facility of a Diphereline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diphereline APIs or Diphereline finished pharmaceutical products to another nation, regulatory agencies frequently require a Diphereline WC (written confirmation) as part of the regulatory process.

click here to find a list of Diphereline suppliers with Written Confirmation (WC) on PharmaCompass.

Diphereline 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 Diphereline as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Diphereline suppliers with NDC on PharmaCompass.

Diphereline GMP

Diphereline 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 Diphereline 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 Diphereline GMP manufacturer or Diphereline GMP API supplier for your needs.

Diphereline CoA

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

Diphereline CoA mostly includes findings from lab analyses of a specific batch. For each Diphereline 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.

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