Synopsis
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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 : 2024-12-31
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 : 62788-288
Start Marketing Date : 2001-06-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (11.25mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Date of Issue : 2020-01-28
Valid Till : 2022-06-27
Written Confirmation Number : WC-0047a3
Address of the Firm : K-28, MIDC, Anandnagar, Ambernath (E), Thane-421 506
NDC Package Code : 59149-006
Start Marketing Date : 2023-02-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (500g/500g)
Marketing Category : BULK INGREDIENT
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
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39931
Submission : 2024-06-27
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
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.
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...
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...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Depot Injection
Dosage Strength : 3.75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Depot Injection
Dosage Strength : 11.25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Depot Injection
Dosage Strength : 22.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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 : 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 : Australia
Brand Name : Decapeptyl
Dosage Form :
Dosage Strength :
Packaging : 7
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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
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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 : 11.25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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 : 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 : 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 : 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
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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 : Sweden
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
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 : 11.25 mg
Packaging : Set
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Depot Injection
Dosage Strength : 3.75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Packaging :
Regulatory Info :
Dosage : Depot Injection
Dosage Strength : 3.75MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Depot Injection
Dosage Strength : 11.25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Packaging :
Regulatory Info :
Dosage : Depot Injection
Dosage Strength : 11.25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Depot Injection
Dosage Strength : 22.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Packaging :
Regulatory Info :
Dosage : Depot Injection
Dosage Strength : 22.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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
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Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders
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Market Place
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12 Mar 2022
Reply
08 Aug 2019
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
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