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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 10 USDMF, 1 EU WC, 18 NDC API, 12 Listed Suppliers, $ API Reference Price

15 API Suppliers
10 USDMF
1 EU WC
18 NDC API
12 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 30 FDA Orange Book, 2 Canada, 1 South Africa, 2 Listed Dossiers

35 FDF Dossiers
30 FDA Orange Book
2 Canada
1 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/ML, INJECTABLE;INJECTION - 200MG/ML

drugProductComposition
INJECTABLE;INJECTION - 100MG/ML
INJECTABLE;INJECTION - 200MG/ML

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 Actylis, 2 Finar, 1 TopChem Pharmaceuticals

relatedExcipients
1 Nanjing Well Pharmaceutical
1 Actylis
2 Finar
1 TopChem Pharmaceuticals

EXCIPIENTS BY APPLICATIONS

3 Topical, 2 Parenteral, 1 Solubilizers

excipientsByApplications
3 Topical
2 Parenteral
1 Solubilizers

DIGITAL CONTENT

28 NEWS #PharmaBuzz

media
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 10 Finished Drug Prices

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2 US Medicaid Prescriptions
10 Finished Drug Prices

MARKET PLACE

5 APIs

marketPlace
5 APIs

PATENTS & EXCLUSIVITIES

2 US Patents

patents
2 US Patents

REF. STANDARDS & IMPURITIES

1 USP , 3 Others

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1 USP
3 Others

Aspen Testosterone Cypionate

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

40,664,392

Annual Reports (USD Million)

Finished Drug Prices

6EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 58-20-8, Depo-testosterone, Depovirin, Jectatest, Testosterone cyclopentylpropionate, Testosterone cyclopentanepropionate

Molecular Formula

C₂₇H₄₀O₃

Molecular Weight

412.6 g/mol

InChI Key

HPFVBGJFAYZEBE-ZLQWOROUSA-N

FDA UNII

M0XW1UBI14

Testosterone Cypionate is an eight-carbon ester form of Testosterone. The number of ester carbon atoms correlate with the half-life of the prodrug. Testosterone inhibits gonadotropin secretion from the pituitary gland and ablates estrogen production in the ovaries, thereby decreasing endogenous estrogen levels. In addition, this agent promotes the maintenance of male sex characteristics and is indicated for testosterone replacement in hypogonadal males. (NCI04)

1 2D Structure

Testosterone Cypionate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[(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] 3-cyclopentylpropanoate

2.1.2 InChI

InChI=1S/C27H40O3/c1-26-15-13-20(28)17-19(26)8-9-21-22-10-11-24(27(22,2)16-14-23(21)26)30-25(29)12-7-18-5-3-4-6-18/h17-18,21-24H,3-16H2,1-2H3/t21-,22-,23-,24-,26-,27-/m0/s1

2.1.3 InChI Key

HPFVBGJFAYZEBE-ZLQWOROUSA-N

2.1.4 Canonical SMILES

CC12CCC3C(C1CCC2OC(=O)CCC4CCCC4)CCC5=CC(=O)CCC35C

2.1.5 Isomeric SMILES

C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2OC(=O)CCC4CCCC4)CCC5=CC(=O)CC[C@]35C

2.2 Other Identifiers

2.2.1 UNII

M0XW1UBI14

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Andronate

2. Depo-testosterone

3. Depo-testosterone Cypionate

4. Deposteron

5. Depostomead

6. Duratest

7. Testa-c

8. Testex Elmu

9. Testosterone 17 Beta-cyclopentanepropionate

10. Testosterone 17 Beta-cyclopentylpropionate

11. Testosterone 17 Beta-cypionate

2.3.2 Depositor-Supplied Synonyms

1. 58-20-8

2. Depo-testosterone

3. Depovirin

4. Jectatest

5. Testosterone Cyclopentylpropionate

6. Testosterone Cyclopentanepropionate

7. Pertestis

8. Testosterone 17beta-cypionate

9. Andro-cyp

10. Dep-test

11. Malogen Cyp

12. Depandro 100

13. Depandro 200

14. T-ionate-p.a

15. Testodrin Prolongatum

16. Testosterone Cipionate

17. Depo-testadiol

18. Durandro

19. Nsc 9157

20. Testosterone Cypionate Ciii

21. M0xw1ubi14

22. Testosterone 17beta-cyclopentylpropionate

23. Testosterone Cypionate [usp]

24. Chebi:9463

25. Testosterone 17.beta.-cyclopentanepropionate

26. Androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17b)-

27. Testosterone, Cyclopentanepropionate

28. Nsc-9157

29. Testosterone 17beta-cyclopentanepropionate

30. Androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17.beta.)-

31. Depo-testosterone Cypionate

32. [(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] 3-cyclopentylpropanoate

33. Testosterone Cypionate (usp)

34. 17-(3-cyclopentyl-1-propionyl)-17beta-hydroxyandrost-4-en-3-one

35. Unii-m0xw1ubi14

36. Testosterone 17.beta.-cypionate

37. Depotest

38. Testosterone 17-beta-cypionate

39. (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 3-cyclopentylpropanoate

40. Einecs 200-368-4

41. Testosterone 17.beta.-cyclopentylpropionate

42. Depo-testosterone Cyclopentylpropionate

43. Brn 3174363

44. Depo-testosterone (tn)

45. Schembl40862

46. 17beta-hydroxyandrost-4-en-3-one Cyclopentylpropionate

47. Chembl1201101

48. Dtxsid901015617

49. Zinc4097468

50. Androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17beta)-

51. Lmst02020074

52. Testosterone Cypionate [vandf]

53. Akos007930349

54. Akos015895326

55. Testosterone Cipionate [mart.]

56. Db13943

57. Ds-3318

58. Testosterone Cipionate [who-dd]

59. Testosterone Cypionate [orange Book]

60. Testosterone Cypionate Ciii [usp-rs]

61. Testosterone Cypionate [usp Monograph]

62. C08156

63. D00957

64. Ab01274709-01

65. 053t944

66. W-105407

67. 3-oxoandrost-4-en-17beta-yl 3-cyclopentylpropanoate

68. Depo-testadiol Component Testosterone Cypionate

69. Q27108401

70. Testosterone Cypionate 100 Microg/ml In Acetonitrile

71. Testosterone Cypionate Component Of Depo-testadiol

72. (17beta)-3-oxoandrost-4-en-17-yl 3-cyclopentylpropanoate

73. 17.beta.-hydroxyandrost-4-en-3-one Cyclopentylpropionate

74. Testosterone 17.beta.-cyclopentanepropionate [mi]

75. 17-(cyclopentyl-1-oxopropoxy)androst-4-en-3-one, (17.beta.)-

76. 3-oxoandrost-4-en-17-yl 3-cyclopentylpropanoate, (17.beta.)- #

77. Testosterone Cypionate, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₇H₄₀O₃
Molecular Weight	412.6 g/mol
XLogP3	6.4
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	5
Exact Mass	412.29774513 g/mol
Monoisotopic Mass	412.29774513 g/mol
Topological Polar Surface Area	43.4 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	732
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

4 Drug and Medication Information

4.1 Drug Indication

Testosterone cypionate is used in males that present conditions derived from a deficiency or absence of endogenous testosterone. These conditions are 1) primary hypogonadism, defined as the testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome or orchidectomy; and 2) hypogonadotropic hypogonadism characterized by idiopathic gonadotropin, LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Administration of ester derivatives of testosterone as testosterone cypionate generates an increase in serum testosterone to levels reaching 400% from the baseline within 24 hours of administration. These androgen levels remain elevated for 3-5 days after initial administration. The continuous variation in plasma testosterone after intramuscular administration of testosterone cypionate results in fluctuations in mood and libido as well as some local inflammation.

5.2 MeSH Pharmacological Classification

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.)

Anabolic Agents

These compounds stimulate anabolism and inhibit catabolism. They stimulate the development of muscle mass, strength, and power. (See all compounds classified as Anabolic Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

Androgen [EPC]; Androstanes [CS]; Androgen Receptor Agonists [MoA]

5.4 Absorption, Distribution and Excretion

Absorption

Testosterone cypionate is an esterified anabolic which allows it to present a greater degree of solubility in fats and thus, the release and absorption occur in a slow rate compare to homologous molecules. Intramuscular administration of 200 mg of testosterone cypionate produced a mean supratherapeutic Cmax of 1122 ng/dl which occurred 4-5 days post-injection. After the fifth day, the levels of testosterone cypionate in plasma went down reaching an average of 400 ng/dl.

Route of Elimination

About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6% of a dose is excreted in the feces, mostly in the unconjugated form.

Volume of Distribution

The volume of distribution following intravenous administration of testosterone is of approximately 1 L/kg.

Clearance

Testosterone cypionate presents a lower clearance rate after intramuscular administration compared to other analogs of testosterone.

5.5 Metabolism/Metabolites

To start its activity, testosterone cypionate has to be processed by enzymes in the bloodstream. These enzymes will break the bond between the cypionate ester moiety and the testosterone. Once separated, testosterone is metabolized to 17-keto steroids through two different pathways. The major active metabolites are estradiol and dihydrotestosterone (DHT). Testosterone is metabolized to DHT by steroid 5-reductase in skin, liver and urogenital tract. In reproductive tissues DHT is further metabolized to androstanediol.

5.6 Biological Half-Life

The half-life of testosterone cypionate is one of the longest, being approximately of 8 days.

5.7 Mechanism of Action

The effects of testosterone in humans and other vertebrates occur by way of two main mechanisms: by activation of the androgen receptor (directly or as DHT), and by conversion to estradiol and activation of certain estrogen receptors. Free testosterone (T) is transported into the cytoplasm of target tissue cells, where it can bind to the androgen receptor, or can be reduced to 5-alpha-dihydrotestosterone (DHT) by the cytoplasmic enzyme 5-alpha-reductase. DHT binds to the same androgen receptor even more strongly than T, so that its androgenic potency is about 2.5 times that of T. The T-receptor or DHT-receptor complex undergoes a structural change that allows it to move into the cell nucleus and bind directly to specific nucleotide sequences of the chromosomal DNA. The areas of binding are called hormone response elements (HREs), and influence transcriptional activity of certain genes, producing the androgen effects.

API SUPPLIERS

01

Aspen API

Netherlands

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Symbiotec Pharmalab

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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Hubei Gedian Humanwell Pharmaceuti...

China

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CPhI India 2024

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Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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Sanofi

France

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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LGM Pharma

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Pfizer CentreOne

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Zhejiang Xianju Pharmaceutical Co....

China

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NDC API

01

Aspen Oss B.V.

Netherlands

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TESTOSTERONE CYPIONATE

NDC Package Code : 60870-0252

Start Marketing Date : 1999-06-18

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

02

Symbiotec Pharmalab Private Limited

India

CPhI India 2024

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TESTOSTERONE CYPIONATE

NDC Package Code : 22552-0010

Start Marketing Date : 2010-04-29

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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Farmabios S.p.A.

Germany

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Axplora- The partner of choice for complex APIs.

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TESTOSTERONE CYPIONATE

NDC Package Code : 46439-8736

Start Marketing Date : 2011-05-01

End Marketing Date : 2024-12-31

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API Reference Price

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