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1. 5-(4-cyanophenoxy)-2,3-dihydro-1-hydroxy-2,1-benzoxaborole
2. An-2728
3. An2728
4. Eucrisa
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
Molecular Weight | 251.05 g/mol |
---|---|
Molecular Formula | C14H10BNO3 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 251.0753733 g/mol |
Monoisotopic Mass | 251.0753733 g/mol |
Topological Polar Surface Area | 62.5 Ų |
Heavy Atom Count | 19 |
Formal Charge | 0 |
Complexity | 361 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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.
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.
D11AH06
D - Dermatologicals
D11 - Other dermatological preparations
D11A - Other dermatological preparations
D11AH - Agents for dermatitis, excluding corticosteroids
D11AH06 - Crisaborole
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.
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.
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-05
Pay. Date : 2019-10-18
DMF Number : 33275
Submission : 2018-10-17
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-07-02
Written Confirmation Number : WC-0191
Address of the Firm :
NDC Package Code : 51686-0005
Start Marketing Date : 2022-11-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33218
Submission : 2018-10-01
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2024-08-28
Valid Till : 2027-08-27
Written Confirmation Number : SD240048
Address of the Firm :
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-04
Pay. Date : 2020-06-04
DMF Number : 34920
Submission : 2020-06-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-04
Pay. Date : 2019-12-18
DMF Number : 34234
Submission : 2019-12-27
Status : Active
Type : II
NDC Package Code : 17337-0546
Start Marketing Date : 2019-04-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-01
Pay. Date : 2020-09-18
DMF Number : 34506
Submission : 2020-09-19
Status : Active
Type : II
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...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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 ...
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...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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...
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...
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, ...
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2-Bromo-5-methoxybenzyl alcohol
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...
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...
4-[4-bromo-3- (hydroxymethyl)phenoxy]benzonitr ile
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...
4-[4-bromo-3- (hydroxymethyl)phenoxy]benzonitr ile
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...
[2-bromo-5-(4- cyanophenoxy)phenyl]methyl acetate
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...
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...
4-[4-Bromo-3-(hydroxymethyl)phenoxy]benzonitrile
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-...
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-...
4-(4-Bromo-3-formylphenoxy)benzonitrile
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-...
Crisaborole
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-...
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : Prescription
Registration Country : Canada
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
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Staquis
Dosage Form : g
Dosage Strength : 2Oin
Packaging : 30X1Oin
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Staquis
Dosage Form : g
Dosage Strength : 2Oin
Packaging : 60X1Oin
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
RLD : Yes
TE Code :
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 :
Regulatory Info : Prescription
Registration Country : Canada
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
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Staquis
Dosage Form : g
Dosage Strength : 2Oin
Packaging : 30X1Oin
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
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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Excipients by Applications
Global Sales Information
Company :
Crisaborole
Drug Cost (USD) : 10,566,575
Year : 2022
Prescribers : 6196
Prescriptions : 12754
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 11,744,648
Year : 2021
Prescribers : 7256
Prescriptions : 14926
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 14,052,208
Year : 2020
Prescribers : 9113
Prescriptions : 18978
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 15,972,730
Year : 2019
Prescribers : 11929
Prescriptions : 22882
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 13,021,342
Year : 2018
Prescribers : 10827
Prescriptions : 19488
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 3,634,363
Year : 2017
Prescribers : 3863
Prescriptions : 5786
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 0
Year : 2016
Prescribers :
Prescriptions : 0
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Crisaborole
Drug Cost (USD) : 0
Year : 2015
Prescribers :
Prescriptions : 0
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2029-12-29
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
Patent Expiration Date : 2029-06-29
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
Patent Expiration Date : 2030-01-20
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
Patent Expiration Date : 2027-02-16
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
Patent Expiration Date : 2027-02-16
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
Patent Expiration Date : 2027-08-16
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
Patent Expiration Date : 2027-08-16
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
Patent Expiration Date : 2030-07-20
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
ABOUT THIS PAGE
43
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Crisaborole API and other APIs are published in this directory by the FDA.
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.
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 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.
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).