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Also known as: 906673-24-3, An-2728, An2728, 4-((1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yl)oxy)benzonitrile, Eucrisa, An 2728
Molecular Formula
C14H10BNO3
Molecular Weight
251.05  g/mol
InChI Key
USZAGAREISWJDP-UHFFFAOYSA-N
FDA UNII
Q2R47HGR7P

Crisaborole
Crisaborole is a novel oxaborole approved by FDA on December 14, 2016 as Eucrisa, a topical treatment of for mild to moderate atopic dermatitis. This non-steroidal agent is efficacious in improving disease severity, reducing the risk of infection and reducing the signs and symptoms in patients 2 years old and older. It reduces the local inflammation in the skin and prevents further exacerbation of the disease with a good safety profile. Its structure contains a boron atom, which facilitates skin penetration and binding to the bimetal center of the phosphodiesterase 4 enzyme. It is currently under development as topical treatment of psoriasis.
Crisaborole is a Phosphodiesterase 4 Inhibitor. The mechanism of action of crisaborole is as a Phosphodiesterase 4 Inhibitor.
1 2D Structure

Crisaborole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(1-hydroxy-3H-2,1-benzoxaborol-5-yl)oxy]benzonitrile
2.1.2 InChI
InChI=1S/C14H10BNO3/c16-8-10-1-3-12(4-2-10)19-13-5-6-14-11(7-13)9-18-15(14)17/h1-7,17H,9H2
2.1.3 InChI Key
USZAGAREISWJDP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
B1(C2=C(CO1)C=C(C=C2)OC3=CC=C(C=C3)C#N)O
2.2 Other Identifiers
2.2.1 UNII
Q2R47HGR7P
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-(4-cyanophenoxy)-2,3-dihydro-1-hydroxy-2,1-benzoxaborole

2. An-2728

3. An2728

4. Eucrisa

2.3.2 Depositor-Supplied Synonyms

1. 906673-24-3

2. An-2728

3. An2728

4. 4-((1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yl)oxy)benzonitrile

5. Eucrisa

6. An 2728

7. Crisaborole (an2728)

8. 5-(4-cyanophenoxy)-2,3-dihydro-1-hydroxy-2,1-benzoxaborole

9. 4-[(1-hydroxy-3h-2,1-benzoxaborol-5-yl)oxy]benzonitrile

10. Crisaborole Topical Ointment 2%

11. Q2r47hgr7p

12. 4-((1-hydroxy-1,3-dihydrobenzo-[c][1,2]oxaborol-5-yl)oxy)benzonitrile

13. Chembl484785

14. Mfcd17169940

15. 4-((1-hydroxy-1,3-dihydrobenzo(c)(1,2)oxaborol-6-yl)oxy)benzonitrile

16. 906673-25-4

17. Staquis

18. 4-(1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yloxy)benzonitrile

19. 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]benzonitrile

20. 4-[(1-hydroxy-1,3-dihydro-2,1-benzoxaborol-5-yl)oxy]benzonitrile

21. Benzonitrile, 4-((1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy)-

22. 4-[(1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yl)oxy]benzonitrile

23. Crisaborole [usan]

24. Unii-q2r47hgr7p

25. Crisaborole [inn]

26. Eucrisa (tn)

27. Crisaborole [mi]

28. Crisaborole (usan/inn)

29. Crisaborole [usan:inn]

30. Crisaborole(an-2728)

31. Crisaborole [who-dd]

32. Schembl595261

33. Gtpl9151

34. Crisaborole, >=98% (hplc)

35. Crisaborole [orange Book]

36. Dtxsid10238231

37. Tqp0866

38. Chebi:134677

39. Bcp08677

40. Ex-a1087

41. Bdbm50277665

42. Akos016005425

43. Zinc169748244

44. Ccg-266972

45. Cs-1057

46. Db05219

47. Sb16802

48. Compound 5b [pmid: 19303290]

49. Ncgc00345792-01

50. Ncgc00345792-02

51. Ncgc00345792-04

52. Ac-30331

53. As-70551

54. Hy-10978

55. Sy113089

56. Db-078771

57. Ft-0767999

58. S5014

59. Pf-06930164

60. C90571

61. C90670

62. D10873

63. F51164

64. 5-(4-cyanophenoxy)-1-hydroxy-2,1-benzoxaborole

65. Q21098894

66. Crisaborole;4-(1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yloxy)benzonitrile;an-2728

67. 1073669-75-6

2.4 Create Date
2010-01-26
3 Chemical and Physical Properties
Molecular Weight 251.05 g/mol
Molecular Formula C14H10BNO3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass251.0753733 g/mol
Monoisotopic Mass251.0753733 g/mol
Topological Polar Surface Area62.5 Ų
Heavy Atom Count19
Formal Charge0
Complexity361
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Intended for the topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.


FDA Label


Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with 40% body surface area (BSA) affected.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Crisaborole has broad-spectrum anti-inflammatory activity by mainly targeting phosphodiesterase 4 (PDE4) enzyme that is a key regulator of inflammatory cytokine production. As this enzyme is expressed in keratinocytes and immune cells, crisaborole mediates an anti-inflammatory effect on almost all inflammatory cells. Topical application of this drug is useful as it potentiates the localization of this drug in the skin and this anti-inflammatory activity is in the low micromolar range.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
CRISABOROLE
5.2.2 FDA UNII
Q2R47HGR7P
5.2.3 Pharmacological Classes
Phosphodiesterase 4 Inhibitors [MoA]; Phosphodiesterase 4 Inhibitor [EPC]
5.3 ATC Code

D11AH06


D - Dermatologicals

D11 - Other dermatological preparations

D11A - Other dermatological preparations

D11AH - Agents for dermatitis, excluding corticosteroids

D11AH06 - Crisaborole


5.4 Absorption, Distribution and Excretion

Absorption

Systemic concentrations of crisaborole were reached by 8 days of twice-daily topical administration. It has low systemic absorption thus poses less risk for developing systemic side effects.


Route of Elimination

Renal excretion of metabolites is the major route of elimination.


5.5 Metabolism/Metabolites

Crisaborole is substantially metabolized into inactive metabolites. The major metabolite 5-(4-cyanophenoxy)-2-hydroxyl benzylalcohol (metabolite 1), is formed via hydrolysis; this metabolite is further metabolized into downstream metabolites, among which 5-(4-cyanophenoxy)-2-hydroxyl benzoic acid (metabolite 2), formed via oxidation, is also a major metabolite.


5.6 Mechanism of Action

Inhibition of PDE4 by crisaborole leads to elevated levels of cyclic adenosine monophosphate (cAMP). Increased intracellular levels of cAMP inhibit the NF-kB pathway and suppress the release of pro-inflammatory mediators such as TNF-alfa and various interleukins that play a causative role in psoriasis and atopic dermatitis. Suppression of downstream effects in different cell types may explain the therapeutic role of crisaborole in immune-mediated skin diseases.


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About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...

Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the Hyderabad-based company has grown from a single manufacturing unit to four, employing over 1,000 people. The manufacturing units are situated in Kazipally, Pashamylaram, Humnabad and Gandhi Nagar. Virupaksha's manufacturing facility holds FDA approval, reflecting its adherence to stringent standards. With a customer base exceeding 300 and a presence spanning over 70 countries, Virupaksha has established itself as a reputable global player in its field.
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About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
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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.
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About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.
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About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...

Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities are located in China, Slovenia, the US, Belgium, Switzerland, Denmark, with more than 6000 employees worldwide. Porton leads the way with its excellent CDMO services, but also supplies APIs & intermediates for the treatment of critical diseases such as HIV/AIDS, diabetes, cancer, & influenza. Our Process Technology Centers & WHO/USFDA/EMA/PDMA/NMPA-inspected Facilities feature state-of-the-art equipment, highly flexible cGMP-compliant production assets.
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About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Cipla

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Crisaborole

About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...

Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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About the Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 years of development, ...

Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 years of development, Nanfang Pharmaceutical has grown into a major domestic manufacturer of anti-tumor raw materials and intermediates, and has expanded to non-anti-tumor drugs. Using the company's accumulated rich experience and first-class technology in plant extraction, the company's product line has been expanded to the field of plant-derived products.
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19-Jul-2021
06-Jan-2025
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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

CAS Number : 150192-39-5

End Use API : Crisaborole

About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...

Virupaksha

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 2973-80-0

End Use API : Crisaborole

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 906673-45-8

End Use API : Crisaborole

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 906673-45-8

End Use API : Crisaborole

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 2227126-09-0

End Use API : Crisaborole

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

06

Amara Labs

India
Excipient World
Not Confirmed
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Amara Labs

India
Excipient World
Not Confirmed
arrow

CAS Number : 2973-80-0

End Use API : Crisaborole

About The Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nat...

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CAS Number : 906673-45-8

End Use API : Crisaborole

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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CAS Number : 2973-80-0

End Use API : Crisaborole

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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CAS Number : 906673-54-9

End Use API : Crisaborole

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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CAS Number : 906673-24-3

End Use API : Crisaborole

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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FDF Dossiers

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Pfizer Inc

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CRISABOROLE

Brand Name : EUCRISA

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 2%

Packaging :

Approval Date : 2016-12-14

Application Number : 207695

Regulatory Info : RX

Registration Country : USA

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Pfizer Inc

U.S.A
PEGS Boston Summit
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Pfizer Inc

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CRISABOROLE

Brand Name : EUCRISA

Dosage Form : OINTMENT

Dosage Strength : 2%/W/W

Packaging : 30/60/100G

Approval Date :

Application Number : 2476991

Regulatory Info : Prescription

Registration Country : Canada

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Pfizer Inc

U.S.A
PEGS Boston Summit
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Pfizer Inc

U.S.A
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Crisaborole

Brand Name : Staquis

Dosage Form : g

Dosage Strength : 2Oin

Packaging : 30X1Oin

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Pfizer Inc

U.S.A
PEGS Boston Summit
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Pfizer Inc

U.S.A
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PEGS Boston Summit
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Crisaborole

Brand Name : Staquis

Dosage Form : g

Dosage Strength : 2Oin

Packaging : 60X1Oin

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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CRISABOROLE

Brand Name : EUCRISA

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 2%

Approval Date : 2016-12-14

Application Number : 207695

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Canada

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CRISABOROLE

Brand Name : EUCRISA

Dosage Form : OINTMENT

Dosage Strength : 2%/W/W

Packaging : 30/60/100G

Approval Date :

Application Number : 2476991

Regulatory Info : Prescription

Registration Country : Canada

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BioProcess International Europe
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Crisaborole

Brand Name : Staquis

Dosage Form : g

Dosage Strength : 2Oin

Packaging : 30X1Oin

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Crisaborole

Brand Name : Staquis

Dosage Form : g

Dosage Strength : 2Oin

Packaging : 60X1Oin

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 10,566,575

Year : 2022

Prescribers : 6196

Prescriptions : 12754

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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 11,744,648

Year : 2021

Prescribers : 7256

Prescriptions : 14926

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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 14,052,208

Year : 2020

Prescribers : 9113

Prescriptions : 18978

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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 15,972,730

Year : 2019

Prescribers : 11929

Prescriptions : 22882

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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 13,021,342

Year : 2018

Prescribers : 10827

Prescriptions : 19488

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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 3,634,363

Year : 2017

Prescribers : 3863

Prescriptions : 5786

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07

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STLE Annual Meeting
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STLE Annual Meeting
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Company :

Crisaborole

Drug Cost (USD) : 0

Year : 2016

Prescribers :

Prescriptions : 0

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08

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Company :

Crisaborole

Drug Cost (USD) : 0

Year : 2015

Prescribers :

Prescriptions : 0

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US Patents

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CRISABOROLE

US Patent Number : 8039451*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-29

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STLE Annual Meeting
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CRISABOROLE

US Patent Number : 8039451

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 207695

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-06-29

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CRISABOROLE

US Patent Number : 8168614

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code : U-1932

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-01-20

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CRISABOROLE

US Patent Number : 9682092

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code : U-1932

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-02-16

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CRISABOROLE

US Patent Number : 8501712

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code : U-1932

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-02-16

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American Thoracic Society
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American Thoracic Society
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CRISABOROLE

US Patent Number : 9682092*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-08-16

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CRISABOROLE

US Patent Number : 8501712*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-08-16

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CRISABOROLE

US Patent Number : 8168614*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 207695

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-07-20

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ABOUT THIS PAGE

Looking for 906673-24-3 / Crisaborole API manufacturers, exporters & distributors?

Crisaborole manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Crisaborole API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Crisaborole manufacturer or Crisaborole supplier for your needs.

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

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

API | Excipient name

Crisaborole

Synonyms

906673-24-3, An-2728, An2728, 4-((1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yl)oxy)benzonitrile, Eucrisa, An 2728

Cas Number

906673-24-3

Unique Ingredient Identifier (UNII)

Q2R47HGR7P

About Crisaborole

Crisaborole is a novel oxaborole approved by FDA on December 14, 2016 as Eucrisa, a topical treatment of for mild to moderate atopic dermatitis. This non-steroidal agent is efficacious in improving disease severity, reducing the risk of infection and reducing the signs and symptoms in patients 2 years old and older. It reduces the local inflammation in the skin and prevents further exacerbation of the disease with a good safety profile. Its structure contains a boron atom, which facilitates skin penetration and binding to the bimetal center of the phosphodiesterase 4 enzyme. It is currently under development as topical treatment of psoriasis.

Crisaborole Manufacturers

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

Crisaborole Suppliers

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

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

Crisaborole USDMF

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

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

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

Crisaborole WC

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

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

Crisaborole 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 Crisaborole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Crisaborole GMP

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

Crisaborole CoA

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

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

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