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ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 19 USDMF, 12 CEP/COS, 1 KDMF, 14 NDC API, 20 Listed Suppliers, $ API Reference Price

38 API Suppliers
19 USDMF
12 CEP/COS
1 KDMF
14 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers, 23 FDA Orange Book, 55 Europe, 23 Canada, 7 South Africa, 5 Listed Dossiers

113 FDF Dossiers
23 FDA Orange Book
55 Europe
23 Canada
7 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.005%, SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;TOPICAL - 0.064%;0.005%, SUSPENSION;TOPICAL - 0.064%;0.005%, AEROSOL, FOAM;TOPICAL - 0.005%

drugProductComposition
CREAM;TOPICAL - 0.005%
SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
OINTMENT;TOPICAL - 0.064%;0.005%
SUSPENSION;TOPICAL - 0.064%;0.005%
AEROSOL, FOAM;TOPICAL - 0.005%

RELATED EXCIPIENT COMPANIES

1 DKSH, 4 Nanjing Well Pharmaceutical, 3 Actylis, 1 Alcedo Pharmachem, 12 BASF, 1 Corel Pharma Chem, 2 Finar, 1 Kerry, 1 Pluviaendo, 1 Seppic, 1 Valens Pharmachem

relatedExcipients
1 DKSH
4 Nanjing Well Pharmaceutical
3 Actylis
1 Alcedo Pharmachem
12 BASF
1 Corel Pharma Chem
2 Finar
1 Kerry
1 Pluviaendo
1 Seppic
1 Valens Pharmachem

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18 Topical, 7 Solubilizers, 5 Parenteral, 5 Emulsifying Agents, 4 Film Formers & Plasticizers, 4 Lubricants & Glidants, 4 Thickeners and Stabilizers, 3 Controlled & Modified Release, 2 Granulation, 2 Direct Compression, 1 Surfactant & Foaming Agents, 1 Coating Systems & Additives

excipientsByApplications
18 Topical
7 Solubilizers
5 Parenteral
5 Emulsifying Agents
4 Film Formers & Plasticizers
4 Lubricants & Glidants
4 Thickeners and Stabilizers
3 Controlled & Modified Release
2 Granulation
2 Direct Compression
1 Surfactant & Foaming Agents
1 Coating Systems & Additives

DIGITAL CONTENT

28 NEWS #PharmaBuzz

media
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 54 Finished Drug Prices, 7 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
54 Finished Drug Prices
7 Annual Reports

MARKET PLACE

10 APIs, 1 FDF Dossiers

marketPlace
10 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 1 Health Canada Patents

patents
18 US Patents
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 2 USP , 1 Others

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3 EDQM
2 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,071,286

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

113

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

16DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

30,042,632

Annual Reports (USD Million)

405

Finished Drug Prices

28 RELATED EXCIPIENT COMPANIES

56EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₂₇H₄₀O₃
Molecular Weight	412.6 g/mol
XLogP3	4.3
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	5
Exact Mass	412.29774513 g/mol
Monoisotopic Mass	412.29774513 g/mol
Topological Polar Surface Area	60.7 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	743
Isotope Atom Count	0
Defined Atom Stereocenter Count	7
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	3
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Calcipotriene
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (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 Ingredient	Calcipotriene
Dosage Form	Ointment; Cream; Solution
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Tolmar; G And W Labs

2 of 6
Drug Name	Dovonex
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (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 Ingredient	Calcipotriene
Dosage Form	Cream
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Leo Pharma As

3 of 6
Drug Name	Sorilux
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	SORILUX 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 Ingredient	Calcipotriene
Dosage Form	Aerosol, foam
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Stiefel Labs

4 of 6
Drug Name	Calcipotriene
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (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 Ingredient	Calcipotriene
Dosage Form	Ointment; Cream; Solution
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Tolmar; G And W Labs

5 of 6
Drug Name	Dovonex
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	Dovonex (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 Ingredient	Calcipotriene
Dosage Form	Cream
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Leo Pharma As

6 of 6
Drug Name	Sorilux
PubMed Health	Calcipotriene (On the skin)
Drug Classes	Antipsoriatic
Drug Label	SORILUX 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 Ingredient	Calcipotriene
Dosage Form	Aerosol, foam
Route	Topical
Strength	0.005%
Market Status	Prescription
Company	Stiefel 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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Certificate Number : R1-CEP 2014-016 - Rev 01

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

01 MC2 Therapeutics

Denmark

Duphat

Not Confirmed

FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CREAM;TOPICAL - 0.005%

USFDA APPLICATION NUMBER - 20554

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

DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 21852

DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 22185

DOSAGE - AEROSOL, FOAM;TOPICAL - 0.005%

USFDA APPLICATION NUMBER - 22563

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Excipients by Applications

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Topical

Solubilizers

Parenteral

Emulsifying Agents

Film Formers & Plasticizers

Lubricants & Glidants

Thickeners and Stabilizers

Controlled & Modified Release

Granulation

Direct Compression

Surfactant & Foaming Agents

Coating Systems & Additives

Digital Content

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NEWS #PharmaBuzz

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Annual Reports

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APIs

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Patents & EXCLUSIVITIES

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EDQM

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USP

Others

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ABOUT THIS PAGE

Calcipotriene Manufacturers

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

Calcipotriene Suppliers

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

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

Calcipotriene USDMF

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

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

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

Calcipotriene KDMF

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

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

After submitting a Calcipotriene 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 Calcipotriene API can apply through the Korea Drug Master File (KDMF).

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

Calcipotriene CEP

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

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

Calcipotriene 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 Calcipotriene as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Calcipotriene GMP

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

Calcipotriene CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

38 API Suppliers

19 USDMF

12 CEP/COS

1 KDMF

14 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

113 FDF Dossiers

23 FDA Orange Book

55 Europe

23 Canada

7 South Africa

5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.005%

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

OINTMENT;TOPICAL - 0.064%;0.005%

SUSPENSION;TOPICAL - 0.064%;0.005%

AEROSOL, FOAM;TOPICAL - 0.005%

RELATED EXCIPIENT COMPANIES

1 DKSH

4 Nanjing Well Pharmaceutical

3 Actylis

1 Alcedo Pharmachem

12 BASF

1 Corel Pharma Chem

2 Finar

1 Kerry

1 Pluviaendo

1 Seppic

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

18 Topical

7 Solubilizers

5 Parenteral

5 Emulsifying Agents

4 Film Formers & Plasticizers

4 Lubricants & Glidants

4 Thickeners and Stabilizers

3 Controlled & Modified Release

2 Granulation

2 Direct Compression

1 Surfactant & Foaming Agents

1 Coating Systems & Additives

DIGITAL CONTENT

28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions

54 Finished Drug Prices

7 Annual Reports

MARKET PLACE

10 APIs

1 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents

1 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM

2 USP

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 1,071,286

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

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