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Chemistry

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Also known as: Calcipotriene, Dovonex, Daivonex, Sorilux, 112965-21-6, Calciptriol
Molecular Formula
C27H40O3
Molecular Weight
412.6  g/mol
InChI Key
LWQQLNNNIPYSNX-UROSTWAQSA-N
FDA UNII
143NQ3779B

Calcipotriol
Calcipotriene is a synthetic vitamin D derivative usually formulated for topical dermatological use, antipsoriatic Calcipotriene (calcipotriol) competes equally with active 1,25-hydroxy-2D3 (the natural form of vitamin D) for 1,25-hydroxy-2D3 receptors in regulating cell proliferation and differentiation. It induces differentiation and suppresses proliferation of keratinocytes, reversing abnormal keratinocyte changes in psoriasis, and leads to normalization of epidermal growth. (NCI04)
Calcipotriene is a Vitamin D Analog.
1 2D Structure

Calcipotriol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5S)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
2.1.2 InChI
InChI=1S/C27H40O3/c1-17(6-13-25(29)20-8-9-20)23-11-12-24-19(5-4-14-27(23,24)3)7-10-21-15-22(28)16-26(30)18(21)2/h6-7,10,13,17,20,22-26,28-30H,2,4-5,8-9,11-12,14-16H2,1,3H3/b13-6+,19-7+,21-10-/t17-,22-,23-,24+,25-,26+,27-/m1/s1
2.1.3 InChI Key
LWQQLNNNIPYSNX-UROSTWAQSA-N
2.1.4 Canonical SMILES
CC(C=CC(C1CC1)O)C2CCC3C2(CCCC3=CC=C4CC(CC(C4=C)O)O)C
2.1.5 Isomeric SMILES
C[C@H](/C=C/[C@H](C1CC1)O)[C@H]2CC[C@@H]\3[C@@]2(CCC/C3=C\C=C/4\C[C@H](C[C@@H](C4=C)O)O)C
2.2 Other Identifiers
2.2.1 UNII
143NQ3779B
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1,24(oh)2-22-ene-24-cyclopropyl D3

2. Calcipotriene

3. Daivonex

4. Dovonex

5. Heximar Win Care

6. Mc 903

7. Mc-903

8. Pri-2205

9. Psorcutan

10. Sorilux

2.3.2 Depositor-Supplied Synonyms

1. Calcipotriene

2. Dovonex

3. Daivonex

4. Sorilux

5. 112965-21-6

6. Calciptriol

7. Psorcutan

8. Calcipotriol Hydrate

9. Mc 903

10. Calcitrene

11. Mc-903

12. Calcipotriene [usan]

13. Calcipotriol [inn]

14. Calcipotriol Anhydrous

15. Chebi:50749

16. Dovonex (tn)

17. 112828-00-9

18. Pri-2201

19. Calcipotriol (jan)

20. 143nq3779b

21. (1r,3s,5z)-5-[(2e)-2-[(1r,3as,7ar)-1-[(e,2r,5s)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol

22. Ncgc00167465-01

23. Calcipotriol [jan]

24. Dsstox_cid_26648

25. Dsstox_rid_81793

26. Dsstox_gsid_46648

27. Divonex

28. (22e)-(24s)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrovitamin D3 / (22e)-(24s)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrocholecalciferol / Calcipotriol

29. (5z,7e,22e)-(1s,3r,24s)-26,27-cyclo-9,10-seco-5,7,10(19),22-cholestatetraene-1,3,24-triol

30. Smr000466353

31. Cas-112965-21-6

32. Sr-01000762910

33. Ccris 7700

34. Unii-143nq3779b

35. Pri 2201

36. Calcipotriene (usp)

37. Bms-181161

38. Calcipotrienemc 903

39. Calcipotriene [mi]

40. Epitope Id:114242

41. Schembl2853

42. Calcipotriene [vandf]

43. Calcipotriol [mart.]

44. Mls000759467

45. Mls001424130

46. Calcipotriol [who-dd]

47. Calcipotriene [usp-rs]

48. Gtpl2778

49. Chembl1200666

50. Dtxsid0046648

51. Amy2864

52. 1s19

53. Hms2051n11

54. Hms2089j08

55. Hms3269p03

56. Hms3413d04

57. Hms3677d04

58. Hms3713k08

59. Mc903

60. Calcipotriene [orange Book]

61. Calcipotriol [ep Monograph]

62. Ex-a4430

63. Zinc3921872

64. Tox21_112469

65. Bdbm50369964

66. Calcipotriene [usp Monograph]

67. Lmst03020106

68. S3739

69. Akos015855239

70. Tox21_112469_1

71. Ccg-100949

72. Cs-0387

73. Db02300

74. Nc00199

75. Stf-115469

76. Ncgc00167465-02

77. (5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol

78. As-56390

79. Cpd000466353

80. Hy-10001

81. D01125

82. U-0267

83. Ab00698343-05

84. 828c009

85. Q155683

86. Sr-01000762910-3

87. Sr-01000762910-4

88. (1?,3?,5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol

89. (1s,3r,5z,7e,14beta,17alpha,22e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol

90. (5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1.alpha.,3.beta.,24-triol

91. (5z,7e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10(19),22-tetraene-1alpha,3beta,24-triol

92. 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1.alpha.,3.beta.,5z,7e,22e,24s)-

93. 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5z,7e,22e,24s)-

2.4 Create Date
2005-11-29
3 Chemical and Physical Properties
Molecular Weight 412.6 g/mol
Molecular Formula C27H40O3
XLogP34.3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass412.29774513 g/mol
Monoisotopic Mass412.29774513 g/mol
Topological Polar Surface Area60.7 Ų
Heavy Atom Count30
Formal Charge0
Complexity743
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count3
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameCalcipotriene
PubMed HealthCalcipotriene (On the skin)
Drug ClassesAntipsoriatic
Drug LabelDovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active IngredientCalcipotriene
Dosage FormOintment; Cream; Solution
RouteTopical
Strength0.005%
Market StatusPrescription
CompanyGlenmark Generics; Fougera Pharms; Tolmar; G And W Labs

2 of 6  
Drug NameDovonex
PubMed HealthCalcipotriene (On the skin)
Drug ClassesAntipsoriatic
Drug LabelDovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active IngredientCalcipotriene
Dosage FormCream
RouteTopical
Strength0.005%
Market StatusPrescription
CompanyLeo Pharma As

3 of 6  
Drug NameSorilux
PubMed HealthCalcipotriene (On the skin)
Drug ClassesAntipsoriatic
Drug LabelSORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog.Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1,3,24-triol. The structural formula is represented below:Molecular...
Active IngredientCalcipotriene
Dosage FormAerosol, foam
RouteTopical
Strength0.005%
Market StatusPrescription
CompanyStiefel Labs

4 of 6  
Drug NameCalcipotriene
PubMed HealthCalcipotriene (On the skin)
Drug ClassesAntipsoriatic
Drug LabelDovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active IngredientCalcipotriene
Dosage FormOintment; Cream; Solution
RouteTopical
Strength0.005%
Market StatusPrescription
CompanyGlenmark Generics; Fougera Pharms; Tolmar; G And W Labs

5 of 6  
Drug NameDovonex
PubMed HealthCalcipotriene (On the skin)
Drug ClassesAntipsoriatic
Drug LabelDovonex (calcipotriene solution) Scalp Solution, 0.005% is a colorless topical solution containing calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatologic use.Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)...
Active IngredientCalcipotriene
Dosage FormCream
RouteTopical
Strength0.005%
Market StatusPrescription
CompanyLeo Pharma As

6 of 6  
Drug NameSorilux
PubMed HealthCalcipotriene (On the skin)
Drug ClassesAntipsoriatic
Drug LabelSORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog.Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1,3,24-triol. The structural formula is represented below:Molecular...
Active IngredientCalcipotriene
Dosage FormAerosol, foam
RouteTopical
Strength0.005%
Market StatusPrescription
CompanyStiefel Labs

4.2 Drug Indication

For the treatment of moderate plaque psoriasis in adults.


Treatment of psoriasis


5 Pharmacology and Biochemistry
5.1 Pharmacology

Calcipotriene is a synthetic analog of vitamin D. In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin.


5.2 MeSH Pharmacological Classification

Dermatologic Agents

Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
CALCIPOTRIENE
5.3.2 FDA UNII
143NQ3779B
5.3.3 Pharmacological Classes
Vitamin D [CS]; Vitamin D Analog [EPC]
5.4 ATC Code

D05AX52

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


D - Dermatologicals

D05 - Antipsoriatics

D05A - Antipsoriatics for topical use

D05AX - Other antipsoriatics for topical use

D05AX02 - Calcipotriol


5.5 Absorption, Distribution and Excretion

Absorption

Clinical studies with radiolabeled ointment indicate that approximately 6% (+3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (+2.6%, SO) when applied to normal skin.


Route of Elimination

The active form of the vitamin, 1,25-dihydroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk.


5.6 Metabolism/Metabolites

Hepatic. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone. The primary metabolites are much less potent than the parent compound.


5.7 Mechanism of Action

The precise mechanism of calcipotriol in remitting psoriasis is not well-understood, however, it has been shown to have comparable affinity with calcitriol for the Vitamin D receptor while being less than 1% the activity in regulating calcium metabolism. The Vitamin D receptor (VDR) belongs to the steroid/thyroid receptor superfamily, and is found on the cells of many different tissues including the thyroid, bone, kindney, and T cells of the immune system. T cells are known to play a role in psoriasis and are believed to undergo modulation of gene expression with binding of calcipotriol to the VDR. This modulation is thought to affect gene products related to cell differentiation and proliferation.


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11-Jan-2021
07-Nov-2024
KGS
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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:

The agreement aims to commercialize Wynzora Cream, a combination of calcipotriene and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis, in Canada.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Wynzora

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Endo Pharm

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement November 15, 2024

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01

Duphat
Not Confirmed
Duphat
Not Confirmed

Details : The agreement aims to commercialize Wynzora Cream, a combination of calcipotriene and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis, in Canada.

Brand Name : Wynzora

Molecule Type : Small molecule

Upfront Cash : Undisclosed

November 15, 2024

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Details:

Enstilar is a combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid, indicated as topical treatment of plaque psoriasis.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Enstilar

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 27, 2024

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Leo Pharma

Denmark
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Duphat
Not Confirmed

Leo Pharma

Denmark
arrow
Duphat
Not Confirmed

Details : Enstilar is a combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid, indicated as topical treatment of plaque psoriasis.

Brand Name : Enstilar

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 27, 2024

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Details:

MC2 gains commercialization rights for Wynzora, an approved product indicated for treating plaque psoriasis in patients 18 years and older, through a license agreement.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Wynzora

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Hyphens Pharma

Deal Size: $2.7 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 12, 2024

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03

Duphat
Not Confirmed
Duphat
Not Confirmed

Details : MC2 gains commercialization rights for Wynzora, an approved product indicated for treating plaque psoriasis in patients 18 years and older, through a license agreement.

Brand Name : Wynzora

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 12, 2024

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Details:

The product is the combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is indicated for the topical treatment of plaque psoriasis.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Enstilar-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 23, 2023

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04

Duphat
Not Confirmed
Duphat
Not Confirmed

Details : The product is the combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is indicated for the topical treatment of plaque psoriasis.

Brand Name : Enstilar-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 23, 2023

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Details:

WYNZORA is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. It is based on PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in aqueous formulation.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Wynzora

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: MC2 Therapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 15, 2022

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05

EPI Health

U.S.A
arrow
Duphat
Not Confirmed

EPI Health

U.S.A
arrow
Duphat
Not Confirmed

Details : WYNZORA is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. It is based on PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in a...

Brand Name : Wynzora

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 15, 2022

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Details:

Positive results from the Phase III study with Lipidor’s drug candidate AKP02, which is based on calcipotriol alone & in combination with betamethasone, show that AKVANO® technology works well for drugs for treatment of psoriasis.


Lead Product(s): Calcipotriol,Betamethasone

Therapeutic Area: Dermatology Brand Name: AKP02

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 20, 2022

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Lipidor AB

Sweden
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Duphat
Not Confirmed

Lipidor AB

Sweden
arrow
Duphat
Not Confirmed

Details : Positive results from the Phase III study with Lipidor’s drug candidate AKP02, which is based on calcipotriol alone & in combination with betamethasone, show that AKVANO® technology works well for drugs for treatment of psoriasis.

Brand Name : AKP02

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 20, 2022

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Details:

Under the terms of this agreement, RELIFE S.r.l shall register, promote, distribute and market Lipidor's calcipotriol based drug candidates for the treatment of psoriasis in EU, Turkey, UK, Switzerland, CIS, and Balkan countries.


Lead Product(s): Calcipotriol,Beclomethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: AKP01

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Menarini

Deal Size: $83.1 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 01, 2021

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Lipidor AB

Sweden
arrow
Duphat
Not Confirmed

Lipidor AB

Sweden
arrow
Duphat
Not Confirmed

Details : Under the terms of this agreement, RELIFE S.r.l shall register, promote, distribute and market Lipidor's calcipotriol based drug candidates for the treatment of psoriasis in EU, Turkey, UK, Switzerland, CIS, and Balkan countries.

Brand Name : AKP01

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 01, 2021

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Details:

AKP02 is a drug candidate for psoriasis that combines calcipotriol and betamethasone and is based on Lipidor’s patented AKVANO® technology.


Lead Product(s): Calcipotriol,Betamethasone

Therapeutic Area: Dermatology Brand Name: AKP02

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2021

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08

Lipidor AB

Sweden
arrow
Duphat
Not Confirmed

Lipidor AB

Sweden
arrow
Duphat
Not Confirmed

Details : AKP02 is a drug candidate for psoriasis that combines calcipotriol and betamethasone and is based on Lipidor’s patented AKVANO® technology.

Brand Name : AKP02

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 22, 2021

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Details:

In this collaboration Almirall will commercialize Wynzora® Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Wynzora

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Almirall

Deal Size: Undisclosed Upfront Cash: $18.0 million

Deal Type: Collaboration February 17, 2021

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09

Duphat
Not Confirmed
Duphat
Not Confirmed

Details : In this collaboration Almirall will commercialize Wynzora® Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.

Brand Name : Wynzora

Molecule Type : Small molecule

Upfront Cash : $18.0 million

February 17, 2021

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Details:

U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis.


Lead Product(s): Calcipotriol,Betamethasone Dipropionate

Therapeutic Area: Dermatology Brand Name: Enstilar

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 22, 2020

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10

Leo Pharma

Denmark
arrow
Duphat
Not Confirmed

Leo Pharma

Denmark
arrow
Duphat
Not Confirmed

Details : U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis.

Brand Name : Enstilar

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 22, 2020

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CREAM;TOPICAL - 0.005%

USFDA APPLICATION NUMBER - 20554

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DOSAGE - SOLUTION;TOPICAL - 0.005% **Federal ...DOSAGE - SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20611

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DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 21852

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DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 22185

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DOSAGE - AEROSOL, FOAM;TOPICAL - 0.005%

USFDA APPLICATION NUMBER - 22563

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ABOUT THIS PAGE

Calcipotriol Manufacturers

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

Calcipotriol Suppliers

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

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

Calcipotriol USDMF

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

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

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

Calcipotriol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Calcipotriol Drug Master File in Korea (Calcipotriol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcipotriol. The MFDS reviews the Calcipotriol KDMF as part of the drug registration process and uses the information provided in the Calcipotriol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Calcipotriol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Calcipotriol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Calcipotriol suppliers with KDMF on PharmaCompass.

Calcipotriol CEP

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

A Calcipotriol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcipotriol 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 Calcipotriol suppliers with CEP (COS) on PharmaCompass.

Calcipotriol 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 Calcipotriol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Calcipotriol 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 Calcipotriol 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 Calcipotriol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcipotriol NDC to their finished compounded human drug products, they may choose to do so.

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

Calcipotriol GMP

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

Calcipotriol CoA

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

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

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