Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
FDF
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Andriol
2. Nebido
3. Pantestone
4. Restandol
5. Testosterone Undecylate
6. Undestor
1. 5949-44-0
2. Andriol
3. Testosterone Undecylate
4. Nebido
5. Testosterone (undecanoate)
6. Aveed
7. Org 538
8. Testosterone Undeconate
9. Jatenzo
10. Testosterone Undecanoate [usan]
11. Testosterone, Undecanoate (ester)
12. Undestor
13. H16a5vct9c
14. Org-538
15. Testosterone 17.beta.-undecylate
16. Tsx-011
17. [(8r,9s,10r,13s,14s,17s)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] Undecanoate
18. Mk-3033
19. Androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17b)-
20. Pantestone
21. Restandol
22. T Undecanoate
23. Testosterone Undecanoate (usan)
24. Rextoro
25. Nebido-r
26. Reandron 1000
27. Einecs 227-712-6
28. Unii-h16a5vct9c
29. Brn 3176734
30. 17beta-hydroxyandrost-4-en-3-one Undecanoate
31. Andriol (tn)
32. Aveed (tn)
33. 5-alpha-androstan-3-one, 17-beta-hydroxy-, Undecanoate
34. Bay 86-5037
35. 3-oxoandrost-4-en-17beta-yl Undecanoate
36. Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)-
37. Testosterone, Undecanoate
38. 4-08-00-00981 (beilstein Handbook Reference)
39. Schembl147620
40. Chembl2107067
41. Clr-610
42. Dtxsid90863661
43. Chebi:135741
44. Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17beta)-
45. (8r,9s,10r,13s,14s,17s)-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl Undecanoate
46. Bcp11921
47. Hy-b0626
48. Zinc8214690
49. Mfcd00468114
50. Testosterone Undecanoate [mi]
51. Akos016010255
52. Cs-4342
53. Db13946
54. Gs-6598
55. Testosterone Undecylate [mart.]
56. 17beta-undecanoyloxy-4-androsten-3-one
57. Testosterone Undecanoate [vandf]
58. Ncgc00484056-01
59. Testosterone Undecanoate [who-dd]
60. Testosterone Undecanoate [orange Book]
61. D06087
62. (17beta)-3-oxoandrost-4-en-17-yl Undecanoate
63. (17-beta)-3-oxoandrost-4-en-17-yl Undecanoate
64. 949t440
65. 3-oxoandrost-4-en-17.beta.-yl Undecanoate
66. W-105318
67. Q15410178
68. 17.beta.-hydroxyandrost-4-en-3-one Undecanoate
69. (17.beta.)-17-hydroxyandrost-4-en-3-one Undecanoate
70. 5-.alpha.-androstan-3-one, 17-.beta.-hydroxy-, Undecanoate
71. Androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17.beta.)-
72. .delta.(sup 4)-androsten-17.beta.-ol-3-one Undecanoate
73. Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-(17.beta.)
74. (1s,2r,10r,11s,14s,15s)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-14-yl Undecanoate
75. (1s,2r,10r,11s,14s,15s)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl Undecanoate
| Molecular Weight | 456.7 g/mol |
|---|---|
| Molecular Formula | C30H48O3 |
| XLogP3 | 8.5 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 11 |
| Exact Mass | 456.36034539 g/mol |
| Monoisotopic Mass | 456.36034539 g/mol |
| Topological Polar Surface Area | 43.4 Ų |
| Heavy Atom Count | 33 |
| Formal Charge | 0 |
| Complexity | 739 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| 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 | Aveed |
| PubMed Health | Testosterone (Injection) |
| Drug Classes | Endocrine-Metabolic Agent |
| Drug Label | Aveed (testosterone undecanoate) injection contains testosterone undecanoate (17-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoat... |
| Active Ingredient | Testosterone undecanoate |
| Dosage Form | Injectable |
| Route | Intramuscular |
| Strength | 750mg/3ml (250mg/ml) |
| Market Status | Prescription |
| Company | Endo Pharms |
| 2 of 2 | |
|---|---|
| Drug Name | Aveed |
| PubMed Health | Testosterone (Injection) |
| Drug Classes | Endocrine-Metabolic Agent |
| Drug Label | Aveed (testosterone undecanoate) injection contains testosterone undecanoate (17-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoat... |
| Active Ingredient | Testosterone undecanoate |
| Dosage Form | Injectable |
| Route | Intramuscular |
| Strength | 750mg/3ml (250mg/ml) |
| Market Status | Prescription |
| Company | Endo Pharms |
Testosterone undecanoate is indicated for replacement therapy in adult males with conditions that are linked with an absence or deficiency in endogenous testosterone production.
FDA Label
Testosterone plays a key role in male sexual differentiation and is involved in regulation of hematopoiesis, body composition, and bone metabolism. As a result, testosterone replacement therapy in males with hypogonadism can result in improved sexual function, increased lean body mass, bone density, erythropoiesis, prostate size, and changes in lipid profiles.
Androgens
Compounds that interact with ANDROGEN RECEPTORS in target tissues to bring about the effects similar to those of TESTOSTERONE. Depending on the target tissues, androgenic effects can be on SEX DIFFERENTIATION; male reproductive organs, SPERMATOGENESIS; secondary male SEX CHARACTERISTICS; LIBIDO; development of muscle mass, strength, and power. (See all compounds classified as Androgens.)
Absorption
The absorption of testosterone undecanoate varies based on the formulation. The intramuscular formulation of testosterone esters is suspended in oil and is absorbed from the lipid phase. Testosterone is released when tissue esterases cleave the undecanoic acid side chain. The oral formulation of testosterone undecanoate is also formulated as a prodrug, is best absorbed with food and ideal absorption occurs when taken with a meal containing at least 30 g of fat.
Route of Elimination
The majority (~90%) of an intramuscularly administered dose of testosterone is conjugated and eliminated in the urine. Approximately 6% of the dose is eliminated primarily unconjugated in the feces.
The side chain of testosterone undecanoate is cleaved by non specific esterases when it enters circulation and the undecanoic acid side chain is metabolized by the beta-oxidation pathway. The resulting Testosterone molecule is then metabolized to dihydrotestosterone (DHT) by the enzyme 5-alpha reductase. DHT is reduced by 3-alpha-hydroxysteroid dehydrogenase (major) and 3-beta-hydroxysteroid dehydrogenase prior to being glucuronidated and cleared by the kidneys. It should be noted that testosterone is metabolized to several other 17-keto steroids in the body.
Based on one source, Testosterone undecanoate in castor oil (for intramuscular injection) has a half life of 33.9 days, allowing it to maintain serum levels in the normal range for over 6 weeks. It should be noted that the half life of testosterone reported in the literature is inconsistent.
Testosterone is produced by Leydig cells and exerts it's effects by binding to androgen receptors throughout the body. Testosterone affects the voice, genitalia, mood, and influences muscle growth and protein expression. Accordingly, males with low levels of testosterone often experience decreased libido, fatigue, mood changes and dysphoria. Exogenous sources of testosterone are designed to mimic the effects of endogenous testosterone.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-26
Pay. Date : 2015-09-24
DMF Number : 14540
Submission : 1999-11-18
Status : Active
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-10-03
DMF Number : 25534
Submission : 2011-11-28
Status : Active
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2016-05-02
DMF Number : 24500
Submission : 2011-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16809
Submission : 2003-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16795
Submission : 2003-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27531
Submission : 2013-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-01
Pay. Date : 2013-07-18
DMF Number : 23934
Submission : 2010-06-28
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
EU WC
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm : Plot No. 5, 6, 7 & 8 Special Economic Zone, Phase II, Pithampur, Dist: Dhar, MP-...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India
Date of Issue : 2020-07-06
Valid Till : 2023-05-24
Written Confirmation Number : WC-0402
Address of the Firm : Plot no. 23-24 GIDC Estate Nandesari-391340 Dist Vadodara Gujarat India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : Australia
Brand Name : Reandron 1000
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Schedule G (CDSA IV)
Registration Country : Canada
Brand Name : TARO-TESTOSTERONE
Dosage Form : CAPSULE
Dosage Strength : 40MG
Packaging : 10
Approval Date :
Application Number : 2421186
Regulatory Info : Schedule G (CDSA IV)
Registration Country : Canada
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances & suspensions.
Regulatory Info :
Registration Country : Austria
Brand Name :
Dosage Form : Solution for Injection
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
Regulatory Info :
Registration Country : Switzerland
Brand Name : Nebido
Dosage Form : Inj. Solution
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : REJUNON 1000
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : KYZATREX
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Packaging :
Approval Date : 2022-07-27
Application Number : 213953
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Nebido
Dosage Form : Solution for injection
Dosage Strength : 1000mg/4ml
Packaging : Vials 4ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : JATENZO
Dosage Form : CAPSULE;ORAL
Dosage Strength : 198MG
Packaging :
Approval Date : 2019-03-27
Application Number : 206089
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code :
Brand Name : KYZATREX
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100MG
Approval Date : 2022-07-27
Application Number : 213953
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : KYZATREX
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Approval Date : 2022-07-27
Application Number : 213953
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : KYZATREX
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Approval Date : 2022-07-27
Application Number : 213953
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : TESTOSTERONE UNDECANOATE
Dosage Form : INJECTABLE;INTRAMUSCULAR
Dosage Strength : 750MG/3ML (250MG/ML)
Approval Date :
Application Number : 207583
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : AVEED
Dosage Form : INJECTABLE;INTRAMUSCULAR
Dosage Strength : 750MG/3ML (250MG/ML)
Approval Date : 2014-03-05
Application Number : 22219
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Nebido
Dosage Form : Solution for injection
Dosage Strength : 1000 mg/4 ml
Packaging : Vials 1 4ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Nebido
Dosage Form : Inj. Solution
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Testosterone-Mepha
Dosage Form : Inj Solution
Dosage Strength : 1000mg/4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Unde Testocaps
Dosage Form : SOFT CAPSULE
Dosage Strength : 40 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebido
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1,000 MG / 4 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]TopChem Pharmaceuticals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Parenteral
Topical
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
LOOKING FOR A SUPPLIER?
Market Place
