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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
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-
Molecular Weight | 1311.4 g/mol |
---|---|
Molecular Formula | C64H82N18O13 |
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 Ų |
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 |
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 |
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.
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.
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.)
QH01CA97
L - Antineoplastic and immunomodulating agents
L02 - Endocrine therapy
L02A - Hormones and related agents
L02AE - Gonadotropin releasing hormone analogues
L02AE04 - Triptorelin
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.
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.
The pharmacokinetics of triptorelin follows a 3 compartment model. The half lives are estimated to be 6 minutes, 45 minutes, and 3 hours respectively.
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.
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6291
Submission : 1986-04-25
Status : Active
Type : II
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
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30364
Submission : 2016-03-11
Status : Active
Type : II
NDC Package Code : 62788-956
Start Marketing Date : 2017-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39931
Submission : 2024-06-27
Status : Active
Type : II
Date of Issue : 2022-08-02
Valid Till : 2025-06-27
Written Confirmation Number : WC-0047
Address of the Firm :
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6291
Submission : 1986-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30364
Submission : 2016-03-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39931
Submission : 2024-06-27
Status : Active
Type : II
Date of Issue : 2022-08-02
Valid Till : 2025-06-27
Written Confirmation Number : WC-0047
Address of the Firm : Plot No. K-28, Additional MIDC, Anandnagar, Ambernath- 421506, Dist- Thane, Maha...
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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
NDC Package Code : 62788-715
Start Marketing Date : 2000-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (3.75mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 62788-437
Start Marketing Date : 2010-10-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 62788-956
Start Marketing Date : 2017-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 62788-288
Start Marketing Date : 2001-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (11.25mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 71161-105
Start Marketing Date : 2010-03-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 71161-106
Start Marketing Date : 2017-09-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 71161-104
Start Marketing Date : 2001-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (11.25mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 71161-103
Start Marketing Date : 2000-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION (3.75mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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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...
About the Company : BCN Peptides is a privately own company completely focused on the cGMP manufacture of Bioactive Peptides for Pharmaceutical and Veterinary applications. We are a customer oriented...
About the Company : CPC is a peptide and Oligonucleotide focused manufacturer founded in 2001 with both facilities in China and US. We are strong at CDMO and CRO for peptide APIs and have proved track...
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...
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...
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...
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...
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Average Price (USD/KGS) |
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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 patients in this region.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Oncology Brand Name: Trelstar
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Debiopharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 02, 2022
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
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 : Hormone
Upfront Cash : Undisclosed
January 02, 2022
Details:
Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin, being developed for pediatric participants for central precocious puberty.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Endocrinology Brand Name: Trelstar
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 09, 2024
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
First Patients Dosed in Phase III Trial of Debio 4326 for Central Precocious Puberty
Details : Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin, being developed for pediatric participants for central precocious puberty.
Product Name : Trelstar
Product Type : Hormone
Upfront Cash : Inapplicable
September 09, 2024
Details:
The net proceeds will be allocated to advancing the company’s pipeline, including FP-014 (triptorelin), a ready-to-use, long-acting injectable developed for the treatment of prostate cancer.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Oncology Brand Name: FP-014
Study Phase: Phase IIProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: $42.1 million Upfront Cash: Undisclosed
Deal Type: Financing April 12, 2024
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $42.1 million
Deal Type : Financing
Foresee Pharmaceuticals Announces Completion of US$42.1 Million Financing
Details : The net proceeds will be allocated to advancing the company’s pipeline, including FP-014 (triptorelin), a ready-to-use, long-acting injectable developed for the treatment of prostate cancer.
Product Name : FP-014
Product Type : Hormone
Upfront Cash : Undisclosed
April 12, 2024
Details:
Dexa Medica’s nation-wide launch and distribution of triptorelin, as Debiopharm’s exclusive Indonesian licensee, will help patients in the region gain access to the pain-relieving benefits of hormone suppression with Pamorelin®.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Pamorelin
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Debiopharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 10, 2021
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Debiopharm
Deal Size : Undisclosed
Deal Type : Collaboration
Details : Dexa Medica’s nation-wide launch and distribution of triptorelin, as Debiopharm’s exclusive Indonesian licensee, will help patients in the region gain access to the pain-relieving benefits of hormone suppression with Pamorelin®.
Product Name : Pamorelin
Product Type : Hormone
Upfront Cash : Undisclosed
July 10, 2021
Details:
The companies have entered into an exclusive agreement that grants Verity Pharmaceuticals Inc. the rights to commercialize Trelstar® (triptorelin pamoate for injectable suspension), a hormone therapy for patients living with prostate cancer.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Oncology Brand Name: Trelstar
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Verity Pharmaceuticals Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 06, 2020
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Verity Pharmaceuticals Inc
Deal Size : Undisclosed
Deal Type : Agreement
Details : The companies have entered into an exclusive agreement that grants Verity Pharmaceuticals Inc. the rights to commercialize Trelstar® (triptorelin pamoate for injectable suspension), a hormone therapy for patients living with prostate cancer.
Product Name : Trelstar
Product Type : Hormone
Upfront Cash : Undisclosed
September 06, 2020
Details:
The agreement grants Knight the rights to commercialize Trelstar® (triptorelin) in Canada.
Lead Product(s): Triptorelin Pamoate
Therapeutic Area: Oncology Brand Name: Trelstar
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Knight Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 01, 2020
Lead Product(s) : Triptorelin Pamoate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Knight Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
Knight Partners With Debiopharm for the Commercialization of Trelstar® in Canada
Details : The agreement grants Knight the rights to commercialize Trelstar® (triptorelin) in Canada.
Product Name : Trelstar
Product Type : Hormone
Upfront Cash : Undisclosed
August 01, 2020
Regulatory Info : Originator
Registration Country : South Africa
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
Regulatory Info : Originator
Registration Country : South Africa
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
Regulatory Info : Originator
Registration Country : South Africa
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Switzerland
Brand Name : Decapeptyl
Dosage Form : Inj L?s
Dosage Strength : 0.1mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : Decapeptyl
Dosage Form :
Dosage Strength : 7 Vials 0.1 Mg + 7 Vials Solv
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Australia
Brand Name : Diphereline
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Generic
Registration Country : Iran
Brand Name : Microrelin
Dosage Form : Injection
Dosage Strength : 3.75MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Iran
Regulatory Info : RX
Registration Country : USA
Brand Name : TRELSTAR
Dosage Form : INJECTABLE;INTRAMUSCULAR
Dosage Strength : EQ 3.75MG BASE/VIAL
Packaging :
Approval Date : 2000-06-15
Application Number : 20715
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pamorelin LA
Dosage Form : Trockensub
Dosage Strength : 3.75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pamorelin LA
Dosage Form : Trockensub
Dosage Strength : 22.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Salvacyl
Dosage Form : Trockensub
Dosage Strength : 11.25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Italy
Brand Name : Decapeptyl
Dosage Form : Tryptoreline 11,25Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial IM 11.25 mg + 1 ampoule solv 2 ml + 1 syringe
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Decapeptyl
Dosage Form :
Dosage Strength : 7 Vials 0.1 Mg + 7 Vials Solv
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Pamorelin
Dosage Form : Powder and liquid to depot injection fluid, suspension
Dosage Strength : 22.5 mg
Packaging : Set
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Pre-Filled Syringe
Dosage Strength : 11.25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage : Pre-Filled Syringe
Dosage Strength : 11.25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Iran
Brand Name : Microrelin
Dosage Form : Injection
Dosage Strength : 3.75MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Iran
Packaging :
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 3.75MG/2ML
Brand Name : Microrelin
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info : Generic
Registration Country : Iran
Brand Name :
Dosage Form : Injection
Dosage Strength : 11.25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Iran
Packaging :
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 11.25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info : Generic
Registration Country : Iran
Brand Name :
Dosage Form : Injection
Dosage Strength : 22.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Iran
Packaging :
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 22.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Injection
Dosage Strength :
Packaging : Three Months Depot
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging : Three Months Depot
Regulatory Info :
Dosage : Injection
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : Iran
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Softgel Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Dosage Form : Orodispersible Tablet
Grade : Not Available
Application : Chewable & Orodispersible Aids
Excipient Details : Ludiflash is a ready-to-use orally disintegrating tablet (ODT) solution with superior mouthfeel.
Pharmacopoeia Ref : Ph. Eur., USP, JP: 90 % mannit...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Excipients by Applications
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Granulation, Solubilizers
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Category : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Granulation, Solubilizers
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Dosage Form : Gel, Softgel Capsule, Solution, Suppository
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Application : Solubilizers, Thickeners and Stabilizers
Excipient Details : It provides solubility and viscosity stability on medium viscosity.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Medium Viscosity
Ingredient(s) : Carboxymethyl cellulose sodium
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Paste, Shampoo, Solution, Syrup, Tablet
Grade : Topical, Oral
Category : Film Formers & Plasticizers, Solubilizers, Surfactant & Foaming Agents, Topical
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Film Formers & Plasticizers, Solubilizers, Surfactant & Foaming Agents, Topical
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Pharmacopoeia Ref : Ph.Eur, USP-NF
Technical Specs : HLB: 15, EO: 20; EXCiPACT
Ingredient(s) : Polysorbate 80
Application : Solubilizers, Thickeners and Stabilizers
Excipient Details : It provides smooth solutions, based on uniform substitution with low viscosity.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Low Viscosity
Ingredient(s) : Carboxymethyl cellulose sodium
Application : Solubilizers, Thickeners and Stabilizers
Excipient Details : It provides solubility and viscosity stability on strong high viscosity.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Strong High Viscosity
Ingredient(s) : Carboxymethyl cellulose sodium
Brand Name : Polysorbate 80 Multi-Compendial
Application : Solubilizers
Excipient Details : A & C's Polysorbate 80 multi-compendial is an excipient which meets USP-NF, EP, BP and JP monographs.
Brand Name : Polysorbate 80 NF
Application : Solubilizers
Excipient Details : A & C's Polysorbate 80 is an excipient which meets the NF monograph.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Granulation, Solubilizers
Grade : Topical, Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Brand Name : Microlex® MLP 520
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : Use in a wide range of oral applications such as wet or dry granulation, excipient of choice for flash release forms.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Available in different particle size as 25.µ, 50.µ, 180.µ
Ingredient(s) : Mannitol
Dosage Form : Orodispersible Tablet
Grade : Not Available
Category : Chewable & Orodispersible Aids, Direct Compression, Granulation
Application : Chewable & Orodispersible Aids, Direct Compression, Granulation
Excipient Details : Ludiflash is a ready-to-use orally disintegrating tablet (ODT) solution with superior mouthfeel.
Pharmacopoeia Ref : Ph. Eur., USP, JP: 90 % mannit...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Global Sales Information
Company : Verity Pharmace
Triptorelin Pamoate
Drug Cost (USD) : 14,231,107
Year : 2023
Prescribers : 2074
Prescriptions : 5660
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Allergan/Verity
Triptorelin Pamoate
Drug Cost (USD) : 355,893
Year : 2022
Prescribers : 119
Prescriptions : 134
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Verity Pharmace
Triptorelin Pamoate
Drug Cost (USD) : 14,688,634
Year : 2022
Prescribers : 2266
Prescriptions : 6291
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Allergan/Verity
Triptorelin Pamoate
Drug Cost (USD) : 2,450,188
Year : 2021
Prescribers : 574
Prescriptions : 1055
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Verity Pharmace
Triptorelin Pamoate
Drug Cost (USD) : 10,920,256
Year : 2021
Prescribers : 1753
Prescriptions : 4538
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Allergan/Verity
Triptorelin Pamoate
Drug Cost (USD) : 10,699,121
Year : 2020
Prescribers : 1955
Prescriptions : 4578
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Allergan Inc.
Triptorelin Pamoate
Drug Cost (USD) : 9,803,246
Year : 2019
Prescribers : 1601
Prescriptions : 4298
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Actavis/Allerga
Triptorelin Pamoate
Drug Cost (USD) : 805,253
Year : 2018
Prescribers : 191
Prescriptions : 349
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Allergan Inc.
Triptorelin Pamoate
Drug Cost (USD) : 9,426,445
Year : 2018
Prescribers : 1575
Prescriptions : 4151
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Actavis/Allerga
Triptorelin Pamoate
Drug Cost (USD) : 5,828,535
Year : 2017
Prescribers : 1405
Prescriptions : 2474
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Dosage Form :
Dosage Strength : 7 Vials 0.1 Mg + 7 Vials Solv
Price Per Pack (Euro) : 44.78
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form : Inj L?s
Dosage Strength : 0.1mg/ml
Price Per Pack (Euro) : 45.38
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Injection fluid, resolution
Dosage Strength : 0.1 mg/ml
Price Per Pack (Euro) : 47.531
Published in :
Country : Norway
RX/OTC/DISCN :
Debiopharm Research & Manufacturing...
Dosage Form : Trockensub
Dosage Strength : 11.25mg
Price Per Pack (Euro) : 320.02
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Debiopharm Research & Manufacturing...
Dosage Form : Trockensub
Dosage Strength : 3.75mg
Price Per Pack (Euro) : 110.49
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Debiopharm Research & Manufacturing...
Dosage Form : Trockensub
Dosage Strength : 22.5mg
Price Per Pack (Euro) : 589.5
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Debiopharm Research & Manufacturing...
Dosage Form : Trockensub
Dosage Strength : 11.25mg
Price Per Pack (Euro) : 292.07
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Institut Produits Synthèse (IPSEN)...
Dosage Form : Powder and liquid to depot injec...
Dosage Strength : 11.25 mg
Price Per Pack (Euro) : 311.81
Published in :
Country : Norway
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Institut Produits Synthèse (IPSEN)...
Dosage Form : Powder and liquid to depot injec...
Dosage Strength : 22.5 mg
Price Per Pack (Euro) : 637.42
Published in :
Country : Norway
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Institut Produits Synthèse (IPSEN)...
Dosage Form : Powder and liquid to depot injec...
Dosage Strength : 3.75 mg
Price Per Pack (Euro) : 123.49
Published in :
Country : Norway
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 472
2019 Revenue in Millions : 493
Growth (%) : -4
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 506
2020 Revenue in Millions : 472
Growth (%) : 18
Main Therapeutic Indication : Oncology
Currency : USD
2022 Revenue in Millions : 568
2021 Revenue in Millions : 506
Growth (%) : 12
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 589
2022 Revenue in Millions : 568
Growth (%) : 3
Main Therapeutic Indication : Oncology
Currency : USD
2024 Revenue in Millions : 556
2023 Revenue in Millions : 589
Growth (%) : -6
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2015 Revenue in Millions : 349
2014 Revenue in Millions : 367
Growth (%) : 5%
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2016 Revenue in Millions : 360
2015 Revenue in Millions : 354
Growth (%) : 2
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2017 Revenue in Millions : 432
2016 Revenue in Millions : 421
Growth (%) : 3
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2018 Revenue in Millions : 421
2017 Revenue in Millions : 394
Growth (%) : 7%
Main Therapeutic Indication : Hormonal Disorders
Currency : USD
2014 Revenue in Millions : 7%
2013 Revenue in Millions :
Growth (%) :
Market Place
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08 May 2025
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22 Aug 2024
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02 Sep 2020
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12 Mar 2022
Reply
08 Aug 2019
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
93
PharmaCompass offers a list of Triptorelin Pamoate 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 Triptorelin Pamoate manufacturer or Triptorelin Pamoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Triptorelin Pamoate manufacturer or Triptorelin Pamoate supplier.
PharmaCompass also assists you with knowing the Triptorelin Pamoate API Price utilized in the formulation of products. Triptorelin Pamoate API Price is not always fixed or binding as the Triptorelin Pamoate Price is obtained through a variety of data sources. The Triptorelin Pamoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Triptorelin Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triptorelin Pamoate, including repackagers and relabelers. The FDA regulates Triptorelin Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triptorelin Pamoate 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 Triptorelin Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Triptorelin Pamoate supplier is an individual or a company that provides Triptorelin Pamoate active pharmaceutical ingredient (API) or Triptorelin Pamoate finished formulations upon request. The Triptorelin Pamoate suppliers may include Triptorelin Pamoate API manufacturers, exporters, distributors and traders.
click here to find a list of Triptorelin Pamoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triptorelin Pamoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Triptorelin Pamoate active pharmaceutical ingredient (API) in detail. Different forms of Triptorelin Pamoate DMFs exist exist since differing nations have different regulations, such as Triptorelin Pamoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triptorelin Pamoate DMF submitted to regulatory agencies in the US is known as a USDMF. Triptorelin Pamoate USDMF includes data on Triptorelin Pamoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triptorelin Pamoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triptorelin Pamoate suppliers with USDMF on PharmaCompass.
A Triptorelin Pamoate written confirmation (Triptorelin Pamoate WC) is an official document issued by a regulatory agency to a Triptorelin Pamoate manufacturer, verifying that the manufacturing facility of a Triptorelin Pamoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Triptorelin Pamoate APIs or Triptorelin Pamoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Triptorelin Pamoate WC (written confirmation) as part of the regulatory process.
click here to find a list of Triptorelin Pamoate suppliers with Written Confirmation (WC) 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 Triptorelin Pamoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Triptorelin Pamoate 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 Triptorelin Pamoate 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 Triptorelin Pamoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Triptorelin Pamoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Triptorelin Pamoate suppliers with NDC on PharmaCompass.
Triptorelin Pamoate 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 Triptorelin Pamoate 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 Triptorelin Pamoate GMP manufacturer or Triptorelin Pamoate GMP API supplier for your needs.
A Triptorelin Pamoate CoA (Certificate of Analysis) is a formal document that attests to Triptorelin Pamoate's compliance with Triptorelin Pamoate specifications and serves as a tool for batch-level quality control.
Triptorelin Pamoate CoA mostly includes findings from lab analyses of a specific batch. For each Triptorelin Pamoate 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.
Triptorelin Pamoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Triptorelin Pamoate EP), Triptorelin Pamoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Triptorelin Pamoate USP).