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Also known as: 152-62-5, Isopregnenone, Hydrogesterone, Duphaston, Hydrogestrone, Gynorest
Molecular Formula
C21H28O2
Molecular Weight
312.4  g/mol
InChI Key
JGMOKGBVKVMRFX-HQZYFCCVSA-N
FDA UNII
90I02KLE8K

Dydrogesterone
A synthetic progestational hormone with no androgenic or estrogenic properties. Unlike many other progestational compounds, dydrogesterone produces no increase in temperature and does not inhibit OVULATION.
1 2D Structure

Dydrogesterone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,9R,10S,13S,14S,17S)-17-acetyl-10,13-dimethyl-1,2,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-one
2.1.2 InChI
InChI=1S/C21H28O2/c1-13(22)17-6-7-18-16-5-4-14-12-15(23)8-10-20(14,2)19(16)9-11-21(17,18)3/h4-5,12,16-19H,6-11H2,1-3H3/t16-,17+,18-,19+,20+,21+/m0/s1
2.1.3 InChI Key
JGMOKGBVKVMRFX-HQZYFCCVSA-N
2.1.4 Canonical SMILES
CC(=O)C1CCC2C1(CCC3C2C=CC4=CC(=O)CCC34C)C
2.1.5 Isomeric SMILES
CC(=O)[C@H]1CC[C@@H]2[C@@]1(CC[C@@H]3[C@H]2C=CC4=CC(=O)CC[C@@]34C)C
2.2 Other Identifiers
2.2.1 UNII
90I02KLE8K
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 6 Dehydro 9 Beta 10 Alpha Progesterone

2. 6-dehydro-9 Beta-10 Alpha-progesterone

3. Dehydrogesterone

4. Duphaston

5. Isopregnenone

2.3.2 Depositor-Supplied Synonyms

1. 152-62-5

2. Isopregnenone

3. Hydrogesterone

4. Duphaston

5. Hydrogestrone

6. Gynorest

7. Gestatron

8. Diphaston

9. Dufaston

10. 10alpha-isopregnenone

11. Duvaron

12. Prodel

13. Retrone

14. Terolut

15. Retro-6-dehydroprogesterone

16. Didrogesterone [dcit]

17. Didrogesterone

18. Dydrogesteronum

19. Delta(6)-retroprogesterone

20. 6-dehydro-retro-progesterone

21. Dydrogesteronum [inn-latin]

22. Dydrogesterona [inn-spanish]

23. Delta(sup 6)-retroprogesterone

24. 9beta,10alpha-pregna-4,6-diene-3,20-dione

25. Retroprogesterone, 6-dehydro-

26. (8s,9r,10s,13s,14s,17s)-17-acetyl-10,13-dimethyl-1,2,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-one

27. Nsc-92336

28. (9beta,10alpha)-pregna-4,6-diene-3,20-dione

29. Mls002153947

30. 90i02kle8k

31. Chebi:31527

32. Dydrogesterona

33. Dsstox_cid_2974

34. Dsstox_rid_76812

35. Dsstox_gsid_22974

36. Didrogesterona

37. Duphaston (tn)

38. Gynorest (tn)

39. 6-dehydro-9beta,10alpha-progesterone

40. Cas-152-62-5

41. Ccris 9069

42. Hsdb 3321

43. Mls002695106

44. 6-dehydroretroprogesterone

45. Einecs 205-806-8

46. 9-beta,10alpha-pregna-4,6-diene-3,20-dione

47. Nsc 92336

48. (9-beta,10-alpha)-pregna-4,6-diene-3,20-dione

49. Pregna-4,6-diene-3,20-dione, (9beta,10alpha)-

50. Unii-90i02kle8k

51. Nsc92336

52. 9-beta,10-alpha-pregna-4,6-diene-3,20-dione

53. Ncgc00016413-01

54. Dydrogesterone [usan:usp:inn:ban:jan]

55. 6-dehydro-9.beta.,10.alpha.-progesterone

56. Prestwick0_000671

57. Prestwick1_000671

58. Prestwick2_000671

59. Prestwick3_000671

60. Dydrogesterone [mi]

61. Pregna-4,6-diene-3,20-dione, (9b,10a)-

62. .delta.6-retroprogesterone

63. Dydrogesterone [inn]

64. Dydrogesterone [jan]

65. Schembl37703

66. Bspbio_000761

67. Dydrogesterone [hsdb]

68. Dydrogesterone [usan]

69. 9.beta.,10.alpha.-pregna-4,6-diene-3,20-dione

70. Spbio_002682

71. Dydrogesterone [mart.]

72. Bpbio1_000839

73. Gtpl2878

74. Pregna-4,6-diene-3,20-dione, (9-beta,10-alpha)-

75. Dydrogesterone [usp-rs]

76. Dydrogesterone [who-dd]

77. Chembl1200853

78. Dtxsid1022974

79. Hy-b0257a

80. 9.beta.,6-diene-3,20-dione

81. Dydrogesterone (jp17/usp/inn)

82. Hms1570g03

83. Hms2097g03

84. Hms2230c10

85. Hms3714g03

86. 9-.beta.,6-diene-3,20-dione

87. Amy23414

88. Bcp12878

89. Zinc3875998

90. Dydrogesterone [orange Book]

91. Tox21_110429

92. Dydrogesterone [ep Monograph]

93. S4097

94. Dydrogesterone [usp Monograph]

95. Akos015895532

96. Tox21_110429_1

97. Ccg-220671

98. Db00378

99. Gs-6735

100. Ncgc00179445-01

101. Ncgc00179445-03

102. Ncgc00179445-04

103. Smr001233286

104. Ab00513884

105. (9?,10?)-pregna-4,6-diene-3,20-dione

106. D01217

107. H10151

108. Pregna-4,20-dione, (9.beta.,10.alpha.)-

109. Ab00513884_04

110. 152d625

111. Sr-01000841256

112. Q4161380

113. Sr-01000841256-2

114. W-108050

115. Brd-k68620903-001-03-1

116. Brd-k68620903-001-11-4

117. Pregna-4,6-diene-3,20-dione, (9.beta.,10.alpha.)

118. (1r,2s,10s,11s,14s,15s)-14-acetyl-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-6,8-dien-5-one

119. (8s,9r,10s,13s,14s,17s)-17-acetyl-10,13-dimethyl-8,9,10,11,12,13,14,15,16,17-decahydro-1h-cyclopenta[a]phenanthren-3(2h)-one

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 312.4 g/mol
Molecular Formula C21H28O2
XLogP33.8
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count2
Rotatable Bond Count1
Exact Mass312.208930132 g/mol
Monoisotopic Mass312.208930132 g/mol
Topological Polar Surface Area34.1 Ų
Heavy Atom Count23
Formal Charge0
Complexity628
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 Therapeutic Uses

Progestational Hormones, Synthetic

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


/Dydrogesterone is indicated as/ Hormone replacement therapy (HRT) for estrogen deficiency symptoms in peri and postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


/EXPTL THER:/ The aim of the present study was to evaluate dydrogesterone for luteal-phase support in assisted reproductive technologies (ART) and to compare it with micronized vaginal progesterone. All patients underwent long-term downregulation with gonadotropin-releasing hormone agonists. In phase I, 498 patients were divided into three groups: long protocol and not at risk of ovarian hyperstimulation syndrome (OHSS) (group A); long protocol and at risk of OHSS (group B); and those in a donor oocyte program (group C). All patients received micronized progesterone 600 mg/day, vaginally. They were also randomized to dydrogesterone 20 mg/day (n = 218) or placebo (n = 280). The pregnancy rate was higher with dydrogesterone than with placebo in group A (33.0% vs. 23.6%), group B (36.8% vs. 28.1%) and group C (42.9% vs. 15.6%; p < 0.001). In phase II, 675 patients were divided into the same three groups (groups D, E and F) and were randomized to dydrogesterone 30 mg/day (n = 366) or micronized progesterone 600 mg/day (n = 309). The pregnancy rate was significantly higher with dydrogesterone than with progesterone in group D (39.1% vs. 26.7%; p < 0.01), group E (41.2% vs. 35.6%; p < 0.01) and group F (48.2% vs. 33.9%; p < 0.001). In conclusion, dydrogesterone is effective in luteal-phase support in ART.

PMID:17943542 Patki A, Pawar VC; Gynecol Endocrinol 23 Suppl 1: 68-72 (2007)


Dydrogesterone has no inherent estrogenic activity and no androgenic effects. Priming with estrogen is necessary prior to use. Drug is claimed to be nonthermogenic and does not consistently inhibit ovulation.

American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 568


Spectrum of progestin therapy has changed & expanded during last few yr. Drug-therapy of choice in endometriosis is medication of progestins for at least 6 months. If patient wants additional children the "more gentle" dydrogesterone should be considered.

VOLKER W; FORTSCHR MED 95(2) 68 (1977)


4.2 Drug Warning

There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (eg endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism); Active or recent arterial thromboembolic disease (eg angina, myocardial infarction); Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal; Known hypersensitivity to the active substances or to any of the excipients; Porphyria.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


Femoston is not indicated during pregnancy. If pregnancy occurs during medication with Femoston, treatment should be withdrawn immediately.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


For more Drug Warnings (Complete) data for DYDROGESTERONE (26 total), please visit the HSDB record page.


4.3 Drug Indication

Used to treat irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency. Also used to prevent natural abortion in patients who have a history of habitual abortions.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, dydrogesterone is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis.


5.2 MeSH Pharmacological Classification

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.)


5.3 ATC Code

G03DB01

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

G03D - Progestogens

G03DB - Pregnadien derivatives

G03DB01 - Dydrogesterone


5.4 Absorption, Distribution and Excretion

Absorption

Rapidly absorbed in the gastrointestinal tract with a bioavailability of 28%.


After oral administration of labelled dydrogesterone, on average 63% of the dose is excreted into the urine. Within 72 hours, excretion is complete.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


After oral administration of dydrogesterone, plasma concentrations of DHD are substantially higher as compared to the parent drug. The AUC and Cmax ratios of DHD to dydrogesterone are in the order of 40 and 25, respectively. Dydrogesterone is rapidly absorbed. The Tmax values of dydrogesterone and DHD vary between 0.5 and 2.5 hours.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


The dihydrodydrogesterone Caverage is 13 ng/mL, the Cmin is 4.1 ng/mL and the Cmax is 63 ng/mL. The dydrogesterone Caverage is 0.38 ng/mL the Cmin is <0.1 ng/mL and the Cmax is 2.5 ng/mL.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


Progestins are reportedly distributed into milk. The possible effects of progestins in milk on nursing infants have not been determined. /Progestins General Statement/

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 3270


5.5 Metabolism/Metabolites

Metabolism is complete to a 20-dihydrodydrogesterone (DHD) metabolite.


In man, dydrogesterone is completely metabolised. The main metabolite of dydrogesterone is 20alpha-dihydrodydrogesterone (DHD) and is present in the urine predominantly as the glucuronic acid conjugate. A common feature of all metabolites characterized is the retention of the 4,6 diene-3-one configuration of the parent compound and the absence of 17alpha-hydroxylation. This explains the absence of estrogenic and androgenic activity.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011 : https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


Dydrogesterone is not excreted in urine as pregnanediol, like progesterone. Analysis of endogenous progesterone production based on pregnanediol excretion therefore remains possible.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011:: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


5.6 Biological Half-Life

Dydrogesterone: 5-7 hours, 20-dihydrodydrogesterone (DHD) metabolite: 14-17 hours


Mean terminal half lives of dydrogesterone and DHD vary between 5 to 7 and 14 to 17 hours, respectively.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


5.7 Mechanism of Action

Dydrogesterone is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus.


Dydrogesterone is an orally-active progestagen. The addition of a progestagen greatly reduces the estrogen-induced risk of endometrial hyperplasia and cancer in non-hysterectomised women, by reducing the growth of the endometrium.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for Femoston (Last updated February 2011). Available from, as of March 2, 2011: https://www.medicines.org.uk/EMC/medicine/2493/SPC/Femoston+1+10mg/


Progestins cannot be equated as group with progesterone because some are inherently estrogenic, some slightly androgenic, and some purely progestational; correspondingly, their ovulation-inhibiting potentialities may be mediated in somewhat different ways. /Progestins/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1444


The 17-hydroxy or acetoxy compounds, on the other hand, elicit responses more nearly resembling those of progesterone. They have little or no estrogenic or androgenic activity and may produce catabolic and slight diuretic effects. The 19-nor derivatives are more effective in postponing the normal menstrual period. /Progestins/

American Society of Health System Pharmacists; AHFS Drug Information 2010. Bethesda, MD. (2010), p. 3271


Accumulating evidence indicates that the neuropeptide substance P (SP) is predominantly involved in neurogenic inflammation and pain perception via its high-affinity neurokinin 1 receptor (NK-1R). Intriguingly, decreased pain sensitivity is found to be associated with high plasma progesterone levels. We hypothesize that progesterone may attenuate nociception and associated inflammatory response via NK-1R-dependent pathways. To address our hypothesis, we incubated splenic lymphocytes from CBA/J female mice with different concentrations of the progesterone derivative dydrogesterone. Subsequently, the expressions of NK-1R and T helper (Th1)-type cytokines were analyzed by flow cytometry. Next, we subcutaneously injected CBA/J mice with 1.25 mg of dydrogesterone in 200-microl sesame oil; control mice were sham-injected. Tail flick test to detect the nociceptive threshold was performed in 30-min intervals upon injection. Lymphocytes were isolated from blood and uterus and analyzed for NK-1R surface expression. Immunohistochemical analyses were performed to investigate the uterine tissue distribution of NK-1R. Dydrogesterone induced a decrease in the percentage of NK-1R+ lymphocytes in vitro and in vivo. Additionally, an increase in Th2-type and a decrease in Th1-type cytokines could be detected in vitro after incubation with dydrogesterone. An increased tail flick latency following dydrogesterone injection supported the concept that decreased expression of the NK-1R on lymphocytes is associated with an increased pain threshold. Taken together, these results clearly reveal a pathway by which dydrogesterone or progesterone respectively modulates the cross talk of the nervous, endocrine and immune systems in inflammation and pain.

PMID:16389545 Orsal AS et al; J Mol Med 84 (2): 159-67 (2006)


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


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Dydrogesterone

Registration Number : 218MF10211

Registrant's Address : C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands

Initial Date of Registration : 2006-02-16

Latest Date of Registration : 2022-07-13

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DYDROGESTERONE

NDC Package Code : 58159-075

Start Marketing Date : 2019-06-14

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (35kg/35kg)

Marketing Category : BULK INGREDIENT

Nuray Chemicals

02

STERLING SPA

Italy
ASC 2024
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STERLING SPA

Italy
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DYDROGESTERONE

NDC Package Code : 64918-1905

Start Marketing Date : 2019-11-13

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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03

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DYDROGESTERONE

NDC Package Code : 64918-1800

Start Marketing Date : 2019-01-11

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Dydrogesterone

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
Gonane Pharma

02

LGM Pharma

U.S.A
  • fda
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  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Dydrogesterone

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

03

Aspen API

Netherlands
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API.

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Dydrogesterone

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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04

  • fda
  • EDQM
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Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Dydrogesterone

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
Nuray Chemicals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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Dydrogesterone

About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotch Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs...

​Headquartered in Fengxian District, Shanghai Minbiotch Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
Shanghai Minbiotech CB

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSigmak Lifesciences: Empowering Business with High-quality Ingredients.

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Dydrogesterone

About the Company : Sigmak Lifesciences is a leading contract manufacturer, merchant exporter, & distributor of pharmaceutical APIs & Fine Chemicals. We excel in Contract Manufacturing, covering a wid...

Sigmak Lifesciences is a leading contract manufacturer, merchant exporter, & distributor of pharmaceutical APIs & Fine Chemicals. We excel in Contract Manufacturing, covering a wide spectrum of intermediates, including advance intermediates, cGMP, & non-GMP intermediates. We represent GMP and WHO-certified manufacturers of APIs & advanced intermediates, offering Distribution & Agency services with rigorous selection processes & regular audits to guarantee top-quality products. Moreover, our global Strategic Sourcing capabilities provide high-quality ingredients & performance chemicals to the Pharmaceuticals & Specialty Chemical Industries.
Sigmak Lifesciences

07

ASC 2024
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Dydrogesterone

About the Company : Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad rang...

Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products. Its core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which it commercializes across geographies. Emcure has launched 6 biosimilars in the Domestic Market & RoW markets & Its subsidiary - Gennova is leading the creation of India’s first indigenous mRNA vaccine to combat COVID- 19 which is currently under trial.
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08

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Dydrogesterone

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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09

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Dydrogesterone

About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...

Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediates, and fine chemicals for worldwide markets. With decades of development, now we grow to a leading and outstanding company. We are not just a trading company, but a comprehensive solutions supplier. With our sound knowledge of pharmaceutical business, our advantage is to integrate resources and adapt to all different demands of markets. We are a young but dynamic and energetic company with high efficient and high flexible decision making system.
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10

LinkChem

China
ASC 2024
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LinkChem

China
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Dydrogesterone

About the Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development, and manufacturing o...

LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development, and manufacturing of key intermediates,API,amino acid and peptides. At LinkChem we support the virtually integrated pharma company with unparralled expertise throughout the entire product lifecycle. We collaborate with both Pharmaceutical and Generic companies from drug development to commercialization.
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API Reference Price

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R. 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CHINA,201108 China","customerAddress":"GF- 1 , GROUND FLOOR,COMMERCE HOUSE"}]
26-Feb-2021
14-Aug-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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(USD/KGS)
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Drugs in Development

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Details:

Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (estradiol/dydrogesterone) to Theramex.


Lead Product(s): Dydrogesterone

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Duphaston

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Theramex

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Divestment October 10, 2023

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01

Viatris

U.S.A
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ASC 2024
Not Confirmed

Viatris

U.S.A
arrow
ASC 2024
Not Confirmed

Details : Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (estradiol/dydrogesterone) to Theramex.

Brand Name : Duphaston

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 10, 2023

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Details:

Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (sstradiol/dydrogesterone) to Theramex and its Women's Healthcare business, primarily related to oral and injectable contraceptives, to Insud Pharma.


Lead Product(s): Dydrogesterone

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Duphaston

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Theramex

Deal Size: $3,370.0 million Upfront Cash: Undisclosed

Deal Type: Divestment October 01, 2023

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02

Viatris

U.S.A
arrow
ASC 2024
Not Confirmed

Viatris

U.S.A
arrow
ASC 2024
Not Confirmed

Details : Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (sstradiol/dydrogesterone) to Theramex and its Women's Healthcare business, primarily related to oral and injectable contraceptives, ...

Brand Name : Duphaston

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 01, 2023

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Details:

Auxiton (dydrogesterone) is a potent orally active progesterone receptor agonist that is used for the treatment of disorders such as premenstrual syndrome, cycle irregularity, endometriosis, threatened miscarriage, and habitual miscarriage, and for postmenopausal hormone therapy.


Lead Product(s): Dydrogesterone

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Auxiton

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 27, 2023

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03

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Auxiton (dydrogesterone) is a potent orally active progesterone receptor agonist that is used for the treatment of disorders such as premenstrual syndrome, cycle irregularity, endometriosis, threatened miscarriage, and habitual miscarriage, and for postm...

Brand Name : Auxiton

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 27, 2023

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Details:

Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.


Lead Product(s): Estradiol,Dydrogesterone

Therapeutic Area: Musculoskeletal Brand Name: Femoston

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 15, 2021

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04

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.

Brand Name : Femoston

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 15, 2021

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Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

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01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Dydrogesterone

Brand Name : Dufaston

Dosage Form : Dydrogesterone 10Mg 14 Joined' Oral Use

Dosage Strength : 14 cpr riv 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Estradiol; Dydrogesterone

Brand Name : Femton Accounts

Dosage Form : Estradiol+Dydrogesterone 1+5Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 1 mg + 5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Estradiol; Dydrogesterone

Brand Name : Femton

Dosage Form : Estradiol+Dydrogesterone 1Mg 14 Units And 1+10Mg 14 Joined' Oral Use

Dosage Strength : 14 cpr riv white + 14 cpr gray rev.

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Estradiol; Dydrogesterone

Brand Name : Femton

Dosage Form : Estradiol+Dydrogesterone 2Mg 14 Units And 2+10Mg 14 Joined' Oral Use

Dosage Strength : 14 cpr riv red + 14 cpr yellow rev.

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Dydrogesteronum

Brand Name : Duphaston

Dosage Form : Tabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Dydrogesteronum

Brand Name : Duphaston

Dosage Form : Tabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Estradiolum; Dydrogesteronum

Brand Name : Femoston conti

Dosage Form : Filmtabl

Dosage Strength : 1/5,

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

Estradiolum; Dydrogesteronum

Brand Name : Femoston conti

Dosage Form : Filmtabl

Dosage Strength : 0.5/2.5

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

Estradiolum; Dydrogesteronum

Brand Name : Femoston

Dosage Form : Tabl

Dosage Strength : 2/10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

Discovery on Target
Not Confirmed
arrow
arrow
Discovery on Target
Not Confirmed

Estradiolum; Dydrogesteronum

Brand Name : Femoston

Dosage Form : Tabl

Dosage Strength : 1/10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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