Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
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Canada
0
Australia
0
South Africa
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1. 1-((2r,3r)-3-(4-(4-cyanophenyl)-1,3-thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-((1rs)-1-((methyl(3-((((methylamino)acetyl)oxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1h-1,2,4-triazol-4-ium Monosulfate
2. 4-(2-((2r,3r)-3-(2,5-difluorophenyl)-3-hydroxy-4-(1h-1,2,4-triazol-1-yl)butan-2-yl)-1,3-thiazol-4-yl)benzonitrile
3. Ak-1820
4. Ak1820
5. Bal 4815
6. Bal 8557
7. Bal-4815
8. Bal-8557
9. Bal-8557-002
10. Bal4815
11. Bal8557
12. Bal8557-002
13. Cresemba
14. Isavuconazole
1. 946075-13-4
2. Cresemba
3. Isavuconazonium (sulfate)
4. Bal-8557-002
5. Isavuconazonium Sulfate [usan]
6. Chebi:85977
7. Ak1820
8. 31q44514jv
9. Ak-1820
10. Bal8557-002
11. [2-[1-[1-[(2r,3r)-3-[4-(4-cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1,2,4-triazol-4-ium-4-yl]ethoxycarbonyl-methylamino]pyridin-3-yl]methyl 2-(methylamino)acetate;hydrogen Sulfate
12. 1-((2r,3r)-3-(4-(4-cyanophenyl)-1,3-thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-((1rs)-1-((methyl(3-((((methylamino)acetyl)oxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1h-1,2,4-triazol-4-ium Monosulfate
13. Glycine, N-methyl-, (2-(((1-(1-((2r,3r)-3-(4-(4-cyanophenyl)-2-thiazolyl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4h-1,2,4-triazolium-4-yl)ethoxy)carbonyl)methylamino)-3-pyridinyl)methyl Ester, Sulfate (1:1)
14. Isavuconazonium Sulfate (usan)
15. 1-((2r,3r)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-(((methylglycyl)oxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1h-1,2,4-triazol-4-ium Hydrogen Sulfate
16. Unii-31q44514jv
17. Chembl3137333
18. Dtxsid901026216
19. Ex-a1786
20. Isavuconazonium Sulfate [jan]
21. Akos030527357
22. Isavuconazonium Sulfate [who-dd]
23. Ac-31126
24. As-35043
25. Hy-100373
26. Cs-0018702
27. Isavuconazonium Sulfate [orange Book]
28. D10643
29. A900138
30. Q27158829
31. (2-{[(1-{1-[(2r,3r)-3-[4-(4-cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1h-1,2,4-triazol-4-ium-4-yl}ethoxy)carbonyl](methyl)amino}pyridin-3-yl)methyl N-methylglycinate Hydrogen Sulfate
Molecular Weight | 814.8 g/mol |
---|---|
Molecular Formula | C35H36F2N8O9S2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 17 |
Rotatable Bond Count | 15 |
Exact Mass | 814.20147343 g/mol |
Monoisotopic Mass | 814.20147343 g/mol |
Topological Polar Surface Area | 273 Ų |
Heavy Atom Count | 56 |
Formal Charge | 0 |
Complexity | 1290 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Treatment of invasive aspergillosis, Treatment of mucormycosis
Treatment of Candida infections
Antifungal Agents
Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38964
Submission : 2023-10-04
Status : Active
Type : II
Available Reg Filing : ASMF |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38781
Submission : 2023-09-22
Status : Active
Type : II
NDC Package Code : 73435-037
Start Marketing Date : 2023-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36974
Submission : 2022-05-06
Status : Active
Type : II
NDC Package Code : 42765-068
Start Marketing Date : 2024-04-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Pfizer has Asia Pacific and China rights for Cresemba (isavuconazole), an intravenous and oral azole antifungal.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $226.0 million Upfront Cash: $3.0 million
Deal Type: Licensing Agreement June 05, 2025
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $226.0 million
Deal Type : Licensing Agreement
Strong Cresemba Sales Performance in Asia Pacific and China Triggers Milestone Payment
Details : Pfizer has Asia Pacific and China rights for Cresemba (isavuconazole), an intravenous and oral azole antifungal.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : $3.0 million
June 05, 2025
Details:
Cresemba, with the active ingredient isavuconazonium sulfate, is an intravenous (i.v.) and oral azole antifungal. Cresemba is marketed in more than 70 countries.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Asahi Kasei Pharma
Deal Size: $68.6 million Upfront Cash: $7.1 million
Deal Type: Licensing Agreement April 24, 2025
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Asahi Kasei Pharma
Deal Size : $68.6 million
Deal Type : Licensing Agreement
Cresemba Sales in Japan Trigger Second Milestone Payment to Basilea
Details : Cresemba, with the active ingredient isavuconazonium sulfate, is an intravenous (i.v.) and oral azole antifungal. Cresemba is marketed in more than 70 countries.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : $7.1 million
April 24, 2025
Details:
Continued strong sales performance of Cresemba® (isavuconazole), an azole antifungal for invasive aspergillosis and mucormycosis, by its license partner Pfizer triggered milestone payment.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $226.0 million Upfront Cash: $3.0 million
Deal Type: Licensing Agreement March 14, 2025
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $226.0 million
Deal Type : Licensing Agreement
Strong Cresemba Sales in Asia Trigger Milestone Payment to Basilea
Details : Continued strong sales performance of Cresemba® (isavuconazole), an azole antifungal for invasive aspergillosis and mucormycosis, by its license partner Pfizer triggered milestone payment.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : $3.0 million
March 14, 2025
Details:
Under the terms of the license agreement, Asahi Kasei Pharma is granted an exclusive license to develop and commercialize Cresemba (isavuconazole) in Japan.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Asahi Kasei Pharma
Deal Size: $68.0 million Upfront Cash: $7.19 million
Deal Type: Licensing Agreement February 05, 2025
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Asahi Kasei Pharma
Deal Size : $68.0 million
Deal Type : Licensing Agreement
Cresemba's Japan Launch Triggers Sales Milestone for Basilea
Details : Under the terms of the license agreement, Asahi Kasei Pharma is granted an exclusive license to develop and commercialize Cresemba (isavuconazole) in Japan.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : $7.19 million
February 05, 2025
Details:
AVIR has license in Canada for Cresemba (isavuconazole sulfate), approved for use in adults and pediatrics from 1 year up to 18 years for invasive aspergillosis and invasive mucormycosis.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Avir Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 28, 2025
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Avir Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Strong Sales Growth for Cresemba and Zevtera Trigger Further Milestone Payments to Basilea
Details : AVIR has license in Canada for Cresemba (isavuconazole sulfate), approved for use in adults and pediatrics from 1 year up to 18 years for invasive aspergillosis and invasive mucormycosis.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 28, 2025
Details:
Cresemba (isavuconazonium sulfate) is the prodrug of isavuconazole which is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 03, 2024
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA in Pediatric Aspergillosis
Details : Cresemba (isavuconazonium sulfate) is the prodrug of isavuconazole which is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 03, 2024
Details:
Cresemba (isavuconazonium sulfate) is the prodrug of isavuconazole which is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 10, 2024
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Strong Cresemba® Sales in Asia Trigger Milestone Payment to Basilea
Details : Cresemba (isavuconazonium sulfate) is the prodrug of isavuconazole which is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 10, 2024
Details:
FDA approves expanded use of Cresemba® (isavuconazonium sulfate), an ergosterol inhibitor, in pediatric patients 1 year of age and older with invasive aspergillosis and invasive mucormycosis.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 27, 2024
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves Pediatric Use of Cresemba®, Triggers CHF 10M Milestone
Details : FDA approves expanded use of Cresemba® (isavuconazonium sulfate), an ergosterol inhibitor, in pediatric patients 1 year of age and older with invasive aspergillosis and invasive mucormycosis.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 27, 2024
Details:
Knight will commercialize Cresemba (isavuconazole sulfate) in Latin America, an azole antifungal for treating adult patients with invasive aspergillosis, licensed for regional distribution.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Knight Therapeutics
Deal Size: Undisclosed Upfront Cash: $11.2 million
Deal Type: Licensing Agreement January 19, 2024
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Knight Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Cresemba® Sales in Latin America Trigger First Sales Milestone Payment to Basilea
Details : Knight will commercialize Cresemba (isavuconazole sulfate) in Latin America, an azole antifungal for treating adult patients with invasive aspergillosis, licensed for regional distribution.
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : $11.2 million
January 19, 2024
Details:
Pfizer has the right to manufacture Cresemba, an intravenous, oral azole antifungal, and exclusively commercialize the drug in Europe, the Asia Pacific and China regions. Isavuconazonium sulfate has been approved in 73 countries for invasive aspergillosis and mucormycosis.
Lead Product(s): Isavuconazonium Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Cresemba
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $1,095.4 million Upfront Cash: $72.3 million
Deal Type: Licensing Agreement November 20, 2023
Lead Product(s) : Isavuconazonium Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $1,095.4 million
Deal Type : Licensing Agreement
Details : Pfizer has the right to manufacture Cresemba, an intravenous, oral azole antifungal, and exclusively commercialize the drug in Europe, the Asia Pacific and China regions. Isavuconazonium sulfate has been approved in 73 countries for invasive aspergillosi...
Product Name : Cresemba
Product Type : Other Small Molecule
Upfront Cash : $72.3 million
November 20, 2023
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PharmaCompass offers a list of Isavuconazonium Sulfate 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 Isavuconazonium Sulfate manufacturer or Isavuconazonium Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isavuconazonium Sulfate manufacturer or Isavuconazonium Sulfate supplier.
PharmaCompass also assists you with knowing the Isavuconazonium Sulfate API Price utilized in the formulation of products. Isavuconazonium Sulfate API Price is not always fixed or binding as the Isavuconazonium Sulfate Price is obtained through a variety of data sources. The Isavuconazonium Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isavuconazonium Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isavuconazonium Sulfate, including repackagers and relabelers. The FDA regulates Isavuconazonium Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isavuconazonium Sulfate 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 Isavuconazonium Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isavuconazonium Sulfate supplier is an individual or a company that provides Isavuconazonium Sulfate active pharmaceutical ingredient (API) or Isavuconazonium Sulfate finished formulations upon request. The Isavuconazonium Sulfate suppliers may include Isavuconazonium Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Isavuconazonium Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isavuconazonium Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Isavuconazonium Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Isavuconazonium Sulfate DMFs exist exist since differing nations have different regulations, such as Isavuconazonium Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isavuconazonium Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Isavuconazonium Sulfate USDMF includes data on Isavuconazonium Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isavuconazonium Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isavuconazonium Sulfate suppliers with USDMF 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 Isavuconazonium Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Isavuconazonium Sulfate 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 Isavuconazonium Sulfate 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 Isavuconazonium Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isavuconazonium Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Isavuconazonium Sulfate suppliers with NDC on PharmaCompass.
Isavuconazonium Sulfate 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 Isavuconazonium Sulfate 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 Isavuconazonium Sulfate GMP manufacturer or Isavuconazonium Sulfate GMP API supplier for your needs.
A Isavuconazonium Sulfate CoA (Certificate of Analysis) is a formal document that attests to Isavuconazonium Sulfate's compliance with Isavuconazonium Sulfate specifications and serves as a tool for batch-level quality control.
Isavuconazonium Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Isavuconazonium Sulfate 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.
Isavuconazonium Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Isavuconazonium Sulfate EP), Isavuconazonium Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isavuconazonium Sulfate USP).