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Chemistry

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Also known as: 54024-22-5, Cerazette, Desogen, Desogestrelum, Org-2969, Mircette
Molecular Formula
C22H30O
Molecular Weight
310.5  g/mol
InChI Key
RPLCPCMSCLEKRS-BPIQYHPVSA-N
FDA UNII
81K9V7M3A3

Desogestrel
A synthetic progestational hormone used often as the progestogenic component of combined oral contraceptive agents (ORAL CONTRACEPTIVES, COMBINED).
Desogestrel is a Progestin.
1 2D Structure

Desogestrel

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-11-methylidene-1,2,3,6,7,8,9,10,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol
2.1.2 InChI
InChI=1S/C22H30O/c1-4-21-14-15(3)20-17-9-7-6-8-16(17)10-11-18(20)19(21)12-13-22(21,23)5-2/h2,8,17-20,23H,3-4,6-7,9-14H2,1H3/t17-,18-,19-,20+,21-,22-/m0/s1
2.1.3 InChI Key
RPLCPCMSCLEKRS-BPIQYHPVSA-N
2.1.4 Canonical SMILES
CCC12CC(=C)C3C(C1CCC2(C#C)O)CCC4=CCCCC34
2.1.5 Isomeric SMILES
CC[C@]12CC(=C)[C@H]3[C@H]([C@@H]1CC[C@]2(C#C)O)CCC4=CCCC[C@H]34
2.2 Other Identifiers
2.2.1 UNII
81K9V7M3A3
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 13 Ethyl 11 Methylene 18,19 Dinor 17 Alpha Pregn 4 En 20 Yn 17 Ol

2. 13-ethyl-11-methylene-18,19-dinor-17 Alpha-pregn-4-en-20-yn-17-ol

3. 18,19-dinorpregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-, (17alpha)-

4. Alpha-pregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-18,19-dinor-17

5. Cerazette

6. Marvelon

7. Org 2969

8. Org-2969

9. Org2969

2.3.2 Depositor-Supplied Synonyms

1. 54024-22-5

2. Cerazette

3. Desogen

4. Desogestrelum

5. Org-2969

6. Mircette

7. Org 2969

8. Desogestrelum [inn-latin]

9. 13-ethyl-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-17-ol

10. (8s,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-11-methylidene-1,2,3,6,7,8,9,10,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol

11. Chebi:4453

12. 81k9v7m3a3

13. Ncgc00167449-01

14. 13-ethyl-11-methylene-18,19-dinorpregn-4-en-20-yn-17alpha-ol

15. Hsdb 3593

16. Sr-01000883959

17. Einecs 258-929-4

18. Desogestrel (usan/inn)

19. Unii-81k9v7m3a3

20. Desogestrel [usan:inn:ban]

21. 18,19-dinorpregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-, (17.alpha.)-

22. Mfcd00869346

23. Desogestrel [mi]

24. Desogestrel [inn]

25. Desogestrel [jan]

26. Dsstox_cid_2898

27. Desogestrel [hsdb]

28. Desogestrel [usan]

29. 18,19-dinorpregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-, (17alpha)-

30. Desogestrel [vandf]

31. Chembl1533

32. Desogestrel [mart.]

33. Dsstox_rid_76779

34. Dsstox_gsid_22898

35. Schembl41341

36. Desogestrel [usp-rs]

37. Desogestrel [who-dd]

38. Gtpl7065

39. Dtxsid6022898

40. Desogestrel [orange Book]

41. 17alpha-ethynyl-11-methylidene-18a-homo-estr-4-en-17beta-ol

42. Desogestrel [ep Monograph]

43. Desogestrel [usp Monograph]

44. Kariva Component Desogestrel

45. Volnea Component Desogestrel

46. Bcp18794

47. Bekyree Component Desogestrel

48. Desogen Component Desogestrel

49. Enskyce Component Desogestrel

50. Pimtrea Component Desogestrel

51. Velivet Component Desogestrel

52. Viorele Component Desogestrel

53. Zinc4097416

54. Tox21_112453

55. 13-ethyl-11-methylene-18,19-dinor-17a-pregn-4-en-20-yn-17-ol

56. Ac-308

57. Bdbm50423510

58. Cyclessa Component Desogestrel

59. Isibloom Component Desogestrel

60. Lmst02030104

61. Mircette Component Desogestrel

62. S4638

63. (17alpha)-13-ethyl-11-methylene-18,19-dinorpregn-4-en-20-yn-17-ol

64. Akos015963198

65. Desogestrel Component Of Kariva

66. Ccg-267585

67. Cs-3686

68. Db00304

69. Desogestrel Component Of Desogen

70. Desogestrel Component Of Velivet

71. Ortho-cept Component Desogestrel

72. Desogestrel Component Of Cyclessa

73. Desogestrel Component Of Mircette

74. As-13022

75. Hy-12516

76. Desogestrel 100 Microg/ml In Acetonitrile

77. Desogestrel Component Of Ortho-cept

78. Cas-54024-22-5

79. B4976

80. D4163

81. C07629

82. C15951

83. D02367

84. Desogestrel, Vetranal(tm), Analytical Standard

85. 024d225

86. Q415304

87. J-520217

88. Sr-01000883959-1

89. Sr-01000883959-2

90. 17alpha-ethynyl-13beta-ethyl-11-methylene-4-gonen-17-ol

91. Desogestrel, British Pharmacopoeia (bp) Reference Standard

92. Desogestrel, European Pharmacopoeia (ep) Reference Standard

93. Desogestrel, United States Pharmacopeia (usp) Reference Standard

94. Desogestrel, Pharmaceutical Secondary Standard; Certified Reference Material

95. Desogestrel For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 310.5 g/mol
Molecular Formula C22H30O
XLogP34.9
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count2
Exact Mass310.229665576 g/mol
Monoisotopic Mass310.229665576 g/mol
Topological Polar Surface Area20.2 Ų
Heavy Atom Count23
Formal Charge0
Complexity605
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameDesogen
Active IngredientDesogestrel; ethinyl estradiol
Dosage FormTablet
RouteOral-28
Strength0.03mg; 0.15mg
Market StatusPrescription
CompanyOrganon Usa

2 of 2  
Drug NameDesogen
Active IngredientDesogestrel; ethinyl estradiol
Dosage FormTablet
RouteOral-28
Strength0.03mg; 0.15mg
Market StatusPrescription
CompanyOrganon Usa

4.2 Therapeutic Uses

Contraceptives, Oral, Synthetic; Progestational Hormones, Synthetic

National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)


Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


Cerazette /is indicated for/ contraception.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


Desogestrel is an synthetic progestogen structurally related to levonorgestrel, with actions and uses similar to those of progestogens in general. It is reported to have potent progestogenic activity and little or no androgenic activity. It is used as the progestogenic component of combined mono- and multiphasic oral contraceptive preparations and as a subdermal implantable 'progestogen-only' contraceptive.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V72 587 (1999)


4.3 Drug Warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


Oral contraceptives like Apri (desogestrel and ethinyl estradiol) tablets should not be used in women who currently have the following conditions: thrombophlebitis or thromboembolic disorders; a past history of deep vein thrombophlebitis or thromboembolic disorders; cerebral vascular or coronary artery disease; known or suspected carcinoma of the breast; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; hepatic adenomas or carcinomas...

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


Cerazette does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 - 0.05 ug etonogestrel per kg body weight per day may be ingested by the child (based on an estimated milk ingestion of 150 mL/kg/day).

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


Epidemiological investigations have associated the use of combined oral contraceptives (COC) with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an estrogenic component is unknown, Cerazette should be discontinued in the event of a thrombosis. Discontinuation of Cerazette should also be considered in case of long-term immobilization due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


For more Drug Warnings (Complete) data for DESOGESTREL (48 total), please visit the HSDB record page.


4.4 Drug Indication

Oral desogestrel is used in combination with [ethinylestradiol] as a contraceptive agent for the prevention of pregnancy. Desogestrel is part of the combined oral contraceptives that contain a mix of estrogen and progestin which inhibit ovulation.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

The effects of desogestrel are divided on reproductive including modification of luteinizing hormone and follicle stimulating hormone, declines on the onset of menstruation, and increases the viscosity of the vaginal fluid; and on metabolic that includes increase insulin secretion and resistance, increased lipase activity, and increased fat deposition. The effect of desogestrel on the lipids has been studied extensively and the results are contradictory. Desogestrel main therapeutic effect due to its mechanism of action is known to be related to the inhibition of the ovulation in 97% of the cycles. This effect was proven in clinical trials in non-breastfeeding women from which the Pearl failure rate was reported to be of 0.17 per 100 women-years. This result indicated that desogestrel is more efficient when compared to other progestogen-only pills. All the therapeutic effect is produced by a transformation of the endometrium followed by an inhibition of the ovulation due to the suppression of other hormones. Desogestrel has been widely confirmed to be related to an increase in the risk of venous thromboembolism due to the driven increased in blood coagulation factors, leading to a pronounced prothrombotic state. However, the effects of desogestrel are known to not impact significantly the level of total cholesterol remaining in the range of change of 10% which allows it to be a molecule that presents a favorable lipid profile.


5.2 MeSH Pharmacological Classification

Contraceptives, Oral, Hormonal

Oral contraceptives which owe their effectiveness to hormonal preparations. (See all compounds classified as Contraceptives, Oral, Hormonal.)


Progestins

Compounds that interact with PROGESTERONE RECEPTORS in target tissues to bring about the effects similar to those of PROGESTERONE. Primary actions of progestins, including natural and synthetic steroids, are on the UTERUS and the MAMMARY GLAND in preparation for and in maintenance of PREGNANCY. (See all compounds classified as Progestins.)


Contraceptives, Oral, Synthetic

Oral contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Oral, Synthetic.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
DESOGESTREL
5.3.2 FDA UNII
81K9V7M3A3
5.3.3 Pharmacological Classes
Established Pharmacologic Class [EPC] - Progestin
5.4 ATC Code

G03AC09

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


G - Genito urinary system and sex hormones

G03 - Sex hormones and modulators of the genital system

G03A - Hormonal contraceptives for systemic use

G03AC - Progestogens

G03AC09 - Desogestrel


5.5 Absorption, Distribution and Excretion

Absorption

After oral administration, desogestrel is rapidly absorbed and it reaches a peak concentration of 2 ng/ml after 1.5 hours. The bioavailability of desogestrel is reported to be in the range of 60-80% and the reported AUC is of 3000 ng.h/ml. Almost all the administered dose is modified to the active metabolite, [etonogestrel].


Route of Elimination

The elimination of desogestrel is found to be mainly renal corresponding to about 6 times the dose eliminated in the bile. The elimination of desogestrel is only done as the metabolites and not as the unchanged drug and about 85% of the administered dose can be excreted as metabolites after 6-8 days.


Volume of Distribution

The apparent volume of distribution of desogestrel is of 1.5 L/kg.


Clearance

The metabolic clearance rate of desogestrel is reported to be of about 2 ml/min/kg.


After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


In the third cycle of use after a single desogestrel and ethinyl estradiol tablet, maximum concentrations of 3-keto-desogestrel of 2,805 +/- 1,203 pg/mL (mean+/-SD) are reached at 1.4+/-0.8 hours. The area under the curve (AUC) is 33,858+/-11,043 pg/mL (hr) after a single dose.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


At steady state, attained from at least day 19 onwards, maximum concentrations of 5,840 +/-1,667 pg/mL are reached at 1.4+/-0.9 hours. The minimum plasma levels of 3-keto-desogestrel at steady state are 1,400+/-560 pg/mL. The AUC0-24 at steady state is 52,299+/-17,878 pg/mL (hr). The mean AUC0 for 3-keto-desogestrel at single dose is significantly lower than the mean AUC0-24 at steady state. This indicates that the kinetics of 3-keto-desogestrel are non-linear due to an increase in binding of 3-keto-desogestrel to sex hormone-binding globulin in the cycle, attributed to increased sex hormone-binding globulin levels which are induced by the daily administration of ethinyl estradiol. Sex hormone-binding globulin levels increased significantly in the third treatment cycle from day 1 (150+/-64 nmol/L) to day 21 (230+/-59 nmol/L).

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


Etonogestrel is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to sex hormone-binding globulin (SHBG).

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


For more Absorption, Distribution and Excretion (Complete) data for DESOGESTREL (8 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Desogestrel is rapidly metabolized in the intestinal mucosa and by first-pass hepatic metabolism to form the major metabolite of desogestrel is [etonogestrel] which is the biologically active metabolite. This modification is described by the hydroxylation in C3 of the desogestrel molecule. Later, etonogestrel is metabolized following the normal pathways of steroid metabolism. On the other hand, due to the 11-methylene side chain, desogestrel cannot be metabolized to other progestins.


In addition to 3-keto-desogestrel, other phase I metabolites are 3alpha-OH-desogestrel, 3beta-OH-desogestrel, and 3alpha-OH-5alpha-H-desogestrel. These other metabolites are not known to have any pharmacologic effects, and are further converted in part by conjugation (phase II metabolism) into polar metabolites, mainly sulfates and glucuronides.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


Desogestrel is metabolized via hydroxylation and dehydrogenation to the active metabolite etonogestrel. Etonogestrel is metabolised via sulphate and glucuronide conjugation.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


Desogestrel is metabolized rapidly and completely in the liver and gut wall. It is metabolized to 3-keto-desogestrel, which mediates its progestogenic effects, and it is not metabolized further to another progestogen. The serum concentrations of 3-keto-desogestrel reached maximum levels within 2-3 hours after oral administration of desogestrel and were subsequently cleared with a half-life of 12-24 hours.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V72 227 (1999)


The metabolism of desogestrel in microsomes from six hours livers in vitro /were studied/. The main metabolite formed was 3-keto-desogestrel; 3alpha-hydroxydesogestrel and 3beta-hydroxydesogestrel were also detected. The metabolism of desogestrel was inhibited by 50% by primaquine at a concentration of 30 umol/L, but not by levonorgestrel at 250 umol/L.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V72 227 (1999)


For more Metabolism/Metabolites (Complete) data for DESOGESTREL (7 total), please visit the HSDB record page.


Desogestrel has known human metabolites that include 3-alpha-hydroxydesogestrel, 3-beta-hydroxy-desogestrel, and Desogestrel 17-O-glucuronide.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

The terminal half-life of desogestrel is determined to be of 30 hours.


Etonogestrel is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


The elimination half-life for 3-keto-desogestrel is approximately 38+/-20 hours at steady state. /3-Keto-desogestrel/

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


5.8 Mechanism of Action

Desogestrel enters the cell passively and acts by binding selectively to the progesterone receptor and generating low androgenic activity. Its binding produces an effect like a transcription factor and thus, it produces modifications in the mRNA synthesis. The active metabolite of desogestrel, [etonogestrel], presents a combination of high progestational activity with minimal intrinsic androgenicity.


Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus, and changes in the endometrium which reduce the likelihood of implantation. Receptor binding studies, as well as studies in animals, have shown that 3-keto-desogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity. The relevance of this latter finding in humans is unknown.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841


In contrast to traditional progestogen-only pills, the contraceptive effect of Cerazette is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/


Recent studies have demonstrated that desogestrel activates the estrogen receptor-alpha at an activity of about 50% of that of 17beta-estradiol but activates the estrogen receptor-beta at an activity of only 20%. Desogestrel and/or its metabolite 3-keto-desogestrel (etonogestrel) were strongly progestogenic (approximately twofold over progesterone), weakly or not androgenic in animal studies in vivo and in-vitro binding assays and weakly or not active on the glucocorticoid receptor. The active metabolite of desogestrel, 3-ketodesogestrel, strongly bound to and activated progesterone receptor-A and, to a slightly lesser extent, progesterone receptor-B

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V91 163 (2007)


Improvement in oral contraceptive formulations was originally achieved through dose reduction of the estrogen and progestogen components. Recently, further improvement was achieved by increasing the selectivity of contraceptive progestins. The ratio between the affinity for the progesterone receptor and the affinity for the androgen receptor is an indicator of progesterone (or androgen) selectivity of a progestin. This ratio (selectivity index) reflects the relative amount of androgenic or progestational effect at a given dose. Relative selectivity can be characterized with in vitro receptor-binding studies and animal pharmacologic experiments. In comparison with levonorgestrel, desogestrel displays markedly lower androgenicity and slightly increased relative progestational activity. In receptor-binding experiments and animal pharmacologic studies, 3-keto-desogestrel, the active metabolite of desogestrel, shows the highest selectivity index. The favorable effect of desogestrel-containing oral contraceptives on lipoprotein metabolism and preexisting androgen-dependent skin disorders and the absence of adverse effects on blood pressure and body weight are attributed to the increased progestin selectivity of desogestrel.

PMID:8447353 Collins D; Am J Obstet Gynecol 168 (3 Pt 2): 1010-6 (1993)


For more Mechanism of Action (Complete) data for DESOGESTREL (6 total), please visit the HSDB record page.


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USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
Symbiotec Pharmalab

03

Symbiotec Pharmalab

India

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

  • fda
  • EDQM
  • WHO-GMP

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

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USDMF CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
Symbiotec Pharmalab

04

Symbiotec Pharmalab

India

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

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
Symbiotec Pharmalab

05

Symbiotec Pharmalab

India

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

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
Symbiotec Pharmalab

06

Curia

U.S.A

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

Peptide Forum
Not Confirmed
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Curia

U.S.A

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

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Peptide Forum
Not Confirmed
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07

Gedeon Richter

Hungary

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

Peptide Forum
Not Confirmed
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Gedeon Richter

Hungary

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

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Peptide Forum
Not Confirmed
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08

Lupin Ltd

India

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

Peptide Forum
Not Confirmed
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Lupin Ltd

India

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

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Peptide Forum
Not Confirmed
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09

Industriale Chimica

Italy

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

Peptide Forum
Not Confirmed
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Industriale Chimica

Italy

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

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Peptide Forum
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF arrow-down EU-WC NDC arrow-down KDMF VMF Others AUDIT
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10

Industriale Chimica

Italy

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

Peptide Forum
Not Confirmed
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Industriale Chimica

Italy

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

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Peptide Forum
Not Confirmed
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CEP/COS

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Virtual BoothAspen API. More than just an API™

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R1-CEP 2009-300 - Rev 00
Valid
Chemical
2016-03-16
1717
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01

ASPEN OSS B.V. Oss NL

Netherlands
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

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Certificate Number : R1-CEP 2009-300 - Rev 00

Status : Valid

Issue Date : 2016-03-16

Type : Chemical

Substance Number : 1717

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02

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

Certificate Number : R1-CEP 2016-035 - Rev 00

Status : Valid

Issue Date : 2021-09-30

Type : Chemical

Substance Number : 1717

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03

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

Certificate Number : R1-CEP 2006-174 - Rev 04

Status : Valid

Issue Date : 2022-02-18

Type : Chemical

Substance Number : 1717

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04

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

Certificate Number : R1-CEP 2006-185 - Rev 00

Status : Valid

Issue Date : 2013-03-22

Type : Chemical

Substance Number : 1717

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05

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

Certificate Number : R1-CEP 2009-217 - Rev 00

Status : Withdrawn by Holder

Issue Date : 2016-02-23

Type : Chemical

Substance Number : 1717

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06

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

Certificate Number : CEP 2023-246 - Rev 00

Status : Valid

Issue Date : 2025-05-09

Type : Chemical

Substance Number : 1717

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07

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

Certificate Number : R1-CEP 2015-219 - Rev 00

Status : Valid

Issue Date : 2021-09-08

Type : Chemical

Substance Number : 1717

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JDMF

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01

Aspen Oss B. V.

Netherlands
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Desogestrel

Registration Number : 303MF10070

Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

Initial Date of Registration : 2021-04-22

Latest Date of Registration : 2021-04-22

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02

Peptide Forum
Not Confirmed
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Peptide Forum
Not Confirmed

Desogestrel

Registration Number : 221MF10125

Registrant's Address : Via E. H. Greig, 13, 21047 Saronno (VARESE) ITALY

Initial Date of Registration : 2009-06-23

Latest Date of Registration : 2009-06-23

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03

Peptide Forum
Not Confirmed
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Peptide Forum
Not Confirmed

Desogestrel

Registration Number : 221MF10126

Registrant's Address : Via E. H. Greig, 13, 21047 Saronno (VARESE) ITALY

Initial Date of Registration : 2009-06-23

Latest Date of Registration : 2009-06-23

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04

Peptide Forum
Not Confirmed
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Peptide Forum
Not Confirmed

Desogestrel

Registration Number : 230MF10041

Registrant's Address : Via E. H. Grieg, 13, 21047 Saronno (VARESE) ITALY

Initial Date of Registration : 2018-02-28

Latest Date of Registration : 2018-02-28

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EU WC

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

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Desogestrel BP/EP

Date of Issue : 2022-08-31

Valid Till : 2025-07-02

Written Confirmation Number : WC-0162Amended

Address of the Firm : Plot No. 5,6,7 & 8, Special Economic Zone, Phase II, Pharma Zone, Pithampur, Dis...

Symbiotec Pharmalab

02

  • fda
  • EDQM
  • WHO-GMP

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

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Desogestrel BP/EP

Date of Issue : 2022-06-30

Valid Till : 2025-07-02

Written Confirmation Number : WC-0161A2

Address of the Firm : 385/2, Gram Pigdamber, Rau, Indore-453331, M.P., India

Symbiotec Pharmalab

03

  • fda
  • EDQM
  • WHO-GMP

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

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Desogestrel BP/EP

Date of Issue : 2022-07-23

Valid Till : 2025-02-07

Written Confirmation Number : WC-0162n

Address of the Firm : Plot No-5,6,7 & 8, Special Economic Zone, Phase-II, Pharma Zone, Pithampur, Dist...

Symbiotec Pharmalab

04

  • fda
  • EDQM
  • WHO-GMP

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

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Desogestrel BP/EP

Date of Issue : 2022-08-31

Valid Till : 2025-02-07

Written Confirmation Number : WC-0162A2

Address of the Firm : Plot No. 5,6,7 &8, Special Economic Zone, Phase II, Pharma Zone, Pithampur, Dist...

Symbiotec Pharmalab
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NDC API

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01

Aspen Oss B.V.

Netherlands
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DESOGESTREL

NDC Package Code : 60870-0460

Start Marketing Date : 1999-08-02

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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02

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
Not Confirmed

DESOGESTREL

NDC Package Code : 55486-1569

Start Marketing Date : 2009-10-29

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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03

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
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DESOGESTREL

NDC Package Code : 63190-0770

Start Marketing Date : 1992-12-10

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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04

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
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DESOGESTREL

NDC Package Code : 63190-0070

Start Marketing Date : 2001-12-17

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

Aspen API

Netherlands
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

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Desogestrel

About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...

Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.
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02

  • fda
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  • WHO-GMP

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

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Desogestrel

About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...

Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable operations, and innovation has driven their commitment to improving global healthcare access. With a state-of-the-art manufacturing facility inaugurated in 2004, Symbiotec has become a trusted provider in the industry. Their certifications including WHO-GMP, ISO, US FDA, and EU GMP showcase their dedication to quality and excellence. Over two decades, they've maintained their position through adaptability, efficiency, and competitive pricing.
Symbiotec Pharmalab

03

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
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Desogestrel

About the Company : Arudavis Labs is in the business of manufacturing and trading of Active Pharmaceutical Ingredients and Formulations. We have been serving the Pharmaceutical and Biotechnology Indus...

Arudavis Labs is in the business of manufacturing and trading of Active Pharmaceutical Ingredients and Formulations. We have been serving the Pharmaceutical and Biotechnology Industries all over the world for the past 10 years with good track regard of keeping our customers happy. We are specialized in the area of Vitamins, Nutraceuticals and Excipients. Our main products are N-Acetyl-L-Cysteine, Pyridoxine Hydrochloride, Thiamine Hydrochloride and Benfotiamine. The company growth is mainly driven by technology based research and development to meet customer demands.
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04

Atomgrid

India
Europ. Pharma Outsourcing
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Atomgrid

India
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Not Confirmed

Desogestrel

About the Company : Atomgrid is a global company that specializes in the manufacturing and sourcing of specialty chemicals. The company manages end-to-end manufacturing and sourcing needs, covering R&...

Atomgrid is a global company that specializes in the manufacturing and sourcing of specialty chemicals. The company manages end-to-end manufacturing and sourcing needs, covering R&D and lab-scale development to bulk manufacturing and doorstep delivery. Atomgrid employs a proprietary tech platform and a team of experienced chemical engineers, PhDs, and project managers to provide customers with a seamless experience. The company aims to deliver unmatched quality, affordability, and speed in the manufacturing and sourcing of specialty chemicals.
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05

Curia

U.S.A
Europ. Pharma Outsourcing
Not Confirmed
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Curia

U.S.A
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Europ. Pharma Outsourcing
Not Confirmed

Desogestrel

About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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06

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
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Desogestrel

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...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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07

Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
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Desogestrel

About the Company : Founded in 2005, Hangzhou Deli Chemical Co., Ltd. is a specialized manufacturing factory of APIs, pharmaceutical intermediates and other chemicals, with production bases in Huzhou,...

Founded in 2005, Hangzhou Deli Chemical Co., Ltd. is a specialized manufacturing factory of APIs, pharmaceutical intermediates and other chemicals, with production bases in Huzhou, Yuhang and Jiande. Our first factory is located in Tangxi Industrial Park of Yuhang District in Hangzhou city, with over 110,000 sqm of lands. There are independent R&D team and well-trained workforces in our company. Well-known for complete production equipments, advanced production methods and a full suite of inspection facilities, we develop, design and produce independently. In collaboration with laboratories of Zhejiang University
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08

Europ. Pharma Outsourcing
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Europ. Pharma Outsourcing
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Desogestrel

About the Company : HANGZHOU THINK CHEMICAL CO., LTD. (THINKCHEM) is an integrative corporation of trade, research and contract manufacture. With about ten years of business experiences on the marketi...

HANGZHOU THINK CHEMICAL CO., LTD. (THINKCHEM) is an integrative corporation of trade, research and contract manufacture. With about ten years of business experiences on the marketing & distribution, Thinkchem specializes in exporting pharmaceuticals, veterinary drugs, feed additives, intermediates, fine chemicals, plants extracts, pesticides, food & nutrition additives. Thinkchem is good at offering excellent outsourcing services to overseas customers as well as laboratory support. Thinkchem is equipped with modern lab apparatus including HPLC, GC. TLC AND NMR, motivated by a team of highly qualified personnel using these equipments.
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09

NEWCHEM SPA

Italy
Europ. Pharma Outsourcing
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NEWCHEM SPA

Italy
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Europ. Pharma Outsourcing
Not Confirmed

Desogestrel

About the Company : NEWCHEM is an independent Italian manufacturer of Active Pharmaceutical Ingredients (APIs) - Steroids, Progestogens, Prostafglandins. NEWCHEM is active on the worldwide Pharmaceut...

NEWCHEM is an independent Italian manufacturer of Active Pharmaceutical Ingredients (APIs) - Steroids, Progestogens, Prostafglandins. NEWCHEM is active on the worldwide Pharmaceutical Manufacturing market. Quality and reliability are guaranteed by the proven experience of EFFECHEM. NEWCHEM recruits only highly specialized personnel to work in compliance with the strictest regulations.The company is constantly updating its procedures to meet the most advanced quality and safety requirements.
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Europ. Pharma Outsourcing
Not Confirmed
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Europ. Pharma Outsourcing
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Desogestrel

About the Company : SWATI SPENTOSE PVT. LTD.(SSPL), a pharmaceutical company based in Mumbai, India having 2 manufacturing sites: SSPL Unit 1 and SSPL Unit 2. Please find attached a brief presentation...

SWATI SPENTOSE PVT. LTD.(SSPL), a pharmaceutical company based in Mumbai, India having 2 manufacturing sites: SSPL Unit 1 and SSPL Unit 2. Please find attached a brief presentation on our company. A USFDA inspected & WHO-GMP certified site, with 3 CEP’S as well as UK-MHRA, EDQM and TGA-Australia compliant API manufacture, specializing in manufacture of Polysaccharides.
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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646677800,"product":"DESOGESTREL BP\/EP 10(MICRONISED)","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"EL QAHIRA (CAIRO)","customer":"TECHNO PHARMACEUTICALS","customerCountry":"EGYPT","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"29880","totalValueFC":"29382.3","currency":"USD","unitRateINR":2239506,"date":"08-Mar-2022","totalValueINR":"2239506","totalValueInUsd":"29382.3","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4003449","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Micronized","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668969000,"product":"DESOGESTREL (MICRONIZED) WORKING","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MYLAN LABORATORIES LIMITED","supplierCountry":"INDIA","foreign_port":"PAOLA","customer":"PHARMADOX HEALTHCARE LTD","customerCountry":"MALTA","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"82.7","totalValueFC":"245.8","currency":"USD","unitRateINR":6687.666666666667,"date":"21-Nov-2022","totalValueINR":"20063","totalValueInUsd":"245.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372900","bill_no":"4007273","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Micronized","supplierPort":"Ahmedabad-ZIPL-SEZ","supplierAddress":"564\/A\/22, ROAD NO.92, HYDERABAD,ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693247400,"product":"DESOGESTREL BP MICRONIZED","address":"114 MARINE CHAMBERS 11 NEW MARINE LINES","city":"MUMBAI","supplier":"SWATI SPENTOSE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"Z TO ORDER AND NA","customerCountry":"THAILAND","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"34700","totalValueFC":"34348.4","currency":"USD","unitRateINR":2845297.926,"date":"29-Aug-2023","totalValueINR":"2845297.926","totalValueInUsd":"34348.4","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Micronized","supplierPort":"BOMBAY AIR","supplierAddress":"114 MARINE CHAMBERS 11 NEW MARINE LINES, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693765800,"product":"DESOGESTREL BP (MICRONIZED)","address":"114 MARINE CHAMBERS ,","city":"MAHARASHTRA","supplier":"SWATI SPENTOSE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"TO ORDER","customerCountry":"THAILAND","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"34700","totalValueFC":"34346","currency":"USD","unitRateINR":2851000,"date":"04-Sep-2023","totalValueINR":"2851000","totalValueInUsd":"34346","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3688137","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"114 MARINE CHAMBERS ,, MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657737000,"product":"DESOGESTREL (DESOGESTREL MICRONIZED) (BATCH NO.L00048300)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"ASPEN OSS BV","supplierCountry":"NETHERLANDS","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.96","actualQuantity":"0.963","unit":"KGS","unitRateFc":"85000","totalValueFC":"84565.9","currency":"EURO","unitRateINR":"6982750","date":"14-Jul-2022","totalValueINR":"6724388.25","totalValueInUsd":"84565.9","indian_port":"BOMBAY AIR","hs_no":"29372300","bill_no":"9543728","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659724200,"product":"DESOGESTREL MICRONIZED (BATCH NO-L00048300)(NO COMMERCIAL VALUE. 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PELLI 17, P.O . 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08-Mar-2022
30-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Fed...DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20301

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DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15M...DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG

USFDA APPLICATION NUMBER - 21090

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ABOUT THIS PAGE

Looking for 54024-22-5 / Desogestrel API manufacturers, exporters & distributors?

Desogestrel manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Desogestrel 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 Desogestrel manufacturer or Desogestrel supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Desogestrel manufacturer or Desogestrel supplier.

PharmaCompass also assists you with knowing the Desogestrel API Price utilized in the formulation of products. Desogestrel API Price is not always fixed or binding as the Desogestrel Price is obtained through a variety of data sources. The Desogestrel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Desogestrel

Synonyms

54024-22-5, Cerazette, Desogen, Desogestrelum, Org-2969, Mircette

Cas Number

54024-22-5

Unique Ingredient Identifier (UNII)

81K9V7M3A3

About Desogestrel

A synthetic progestational hormone used often as the progestogenic component of combined oral contraceptive agents (ORAL CONTRACEPTIVES, COMBINED).

Cerazette Manufacturers

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

Cerazette Suppliers

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

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

Cerazette USDMF

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

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

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

Cerazette JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Cerazette Drug Master File in Japan (Cerazette JDMF) empowers Cerazette API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Cerazette JDMF during the approval evaluation for pharmaceutical products. At the time of Cerazette JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Cerazette suppliers with JDMF on PharmaCompass.

Cerazette CEP

A Cerazette CEP of the European Pharmacopoeia monograph is often referred to as a Cerazette Certificate of Suitability (COS). The purpose of a Cerazette CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cerazette EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cerazette to their clients by showing that a Cerazette CEP has been issued for it. The manufacturer submits a Cerazette CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cerazette CEP holder for the record. Additionally, the data presented in the Cerazette CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cerazette DMF.

A Cerazette CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cerazette CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Cerazette suppliers with CEP (COS) on PharmaCompass.

Cerazette WC

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

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

Cerazette NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cerazette as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cerazette API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Cerazette as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cerazette and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cerazette NDC to their finished compounded human drug products, they may choose to do so.

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

Cerazette GMP

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

Cerazette CoA

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

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

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

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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