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    Chemistry

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    Also known as: Eraxis, 166663-25-8, Ecalta, V-echinocandin, Ver-002, Ly303366
    Molecular Formula
    C58H73N7O17
    Molecular Weight
    1140.2  g/mol
    InChI Key
    JHVAMHSQVVQIOT-MFAJLEFUSA-N
    FDA UNII
    9HLM53094I
    Anidulafungin
    Echinocandin antifungal agent that is used in the treatment of CANDIDEMIA and CANDIDIASIS.
    Anidulafungin is an Echinocandin Antifungal.
    1 2D Structure

    Anidulafungin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-6-[(1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-18-yl]-4-[4-(4-pentoxyphenyl)phenyl]benzamide
    2.1.2 InChI
    InChI=1S/C58H73N7O17/c1-5-6-7-24-82-40-22-18-35(19-23-40)33-10-8-32(9-11-33)34-12-14-37(15-13-34)51(74)59-41-26-43(70)54(77)63-56(79)47-48(71)29(2)27-65(47)58(81)45(31(4)67)61-55(78)46(50(73)49(72)36-16-20-38(68)21-17-36)62-53(76)42-25-39(69)28-64(42)57(80)44(30(3)66)60-52(41)75/h8-23,29-31,39,41-50,54,66-73,77H,5-7,24-28H2,1-4H3,(H,59,74)(H,60,75)(H,61,78)(H,62,76)(H,63,79)/t29-,30+,31+,39+,41-,42-,43+,44-,45-,46-,47-,48-,49-,50-,54+/m0/s1
    2.1.3 InChI Key
    JHVAMHSQVVQIOT-MFAJLEFUSA-N
    2.1.4 Canonical SMILES
    CCCCCOC1=CC=C(C=C1)C2=CC=C(C=C2)C3=CC=C(C=C3)C(=O)NC4CC(C(NC(=O)C5C(C(CN5C(=O)C(NC(=O)C(NC(=O)C6CC(CN6C(=O)C(NC4=O)C(C)O)O)C(C(C7=CC=C(C=C7)O)O)O)C(C)O)C)O)O)O
    2.1.5 Isomeric SMILES
    CCCCCOC1=CC=C(C=C1)C2=CC=C(C=C2)C3=CC=C(C=C3)C(=O)N[C@H]4C[C@H]([C@H](NC(=O)[C@@H]5[C@H]([C@H](CN5C(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H]6C[C@H](CN6C(=O)[C@@H](NC4=O)[C@@H](C)O)O)[C@@H]([C@H](C7=CC=C(C=C7)O)O)O)[C@@H](C)O)C)O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    9HLM53094I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-((4r,5r)-4,5-dihydroxy-n2-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-l-ornithine)-echinocandin B

    2. Eraxis

    3. Ly 303366

    4. Ly-303366

    5. Ly303366

    2.3.2 Depositor-Supplied Synonyms

    1. Eraxis

    2. 166663-25-8

    3. Ecalta

    4. V-echinocandin

    5. Ver-002

    6. Ly303366

    7. Ly-303366

    8. Anidulafungin (ly303366)

    9. Ver002

    10. Chebi:55346

    11. 9hlm53094i

    12. D70013

    13. D-70013

    14. N-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-6-[(1s,2s)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-18-yl]-4-[4-(4-pentoxyphenyl)phenyl]benzamide

    15. Anidulafungin [usan]

    16. Anidulafungina

    17. Anidulafungine

    18. Anidulafunginum

    19. Unii-9hlm53094i

    20. Anidulafungin [usan:inn:ban]

    21. Anidulafungin [mi]

    22. Anidulafungin [inn]

    23. Schembl38292

    24. Anidulafungin [vandf]

    25. (4r,5r)-4,5-dihydroxy-n(sup 2)-((4'-(pentyloxy)-p-terphenyl-4-yl)carbonyl)-l-ornithyl-l-threonyl-trans-4-hydroxy-l-prolyl-(s)-4-hydroxy-4-(p-hydroxyphenyl)-l-threonyl-l-threonyl-(3s,4s)-3-hydroxy-4-methyl-l-proline Cyclic (6-1)-peptide

    26. Anidulafungin [mart.]

    27. Anidulafungin [who-dd]

    28. Chembl264241

    29. Anidulafungin [ema Epar]

    30. Anidulafungin [orange Book]

    31. Bdbm50417554

    32. Mfcd00917070

    33. S4286

    34. Ccg-270647

    35. Cs-1824

    36. Db00362

    37. Ncgc00386349-01

    38. Hy-13553

    39. Sw222238-1

    40. A13436

    41. 663a258

    42. J-010304

    43. Q4764531

    44. (4r,5r)-4,5-dihydroxy-n(sup 2)-((4''-(pentyloxy)-p-terphenyl-4-yl)carbonyl)-l-ornithyl-l-threonyl-trans-4-hydroxy-l-prolyl-(s)-4-hydroxy-4-(p-hydroxyphenyl)-l-threonyl-l-threonyl-(3s,4s)-3-hydroxy-4-methyl-l-proline Cyclic (6->1)-peptide

    45. Echinocandin B, 1-((4r,5r)-4,5-dihydroxy-n(sup 2)-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-l-ornithine)-

    46. Echinocandin B, 1-((4r,5r)-4,5-dihydroxy-n2-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-l-ornithine)

    47. N-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-6-[(1s,2s)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.0^{9,13}]heptacosan-18-yl]-4-{4-[4-(pentyloxy)phenyl]phenyl}benzamide

    48. N-[[(1s,2s)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-tetrahydroxy-bis[(1r)-1-hydroxyethyl]-methyl-hexaoxo-[?]yl]-4-[4-(4-pentoxyphenyl)phenyl]benzamide

    49. N-{(2r,6s,9s,11r,12r,14as,15s,16s,20s,23s,25as)-23-[(1s,2s)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-2,11,12,15-tetrahydroxy-6,20-bis[(1r)-1-hydroxyethyl]-16-methyl-5,8,14,19,22,25-hexaoxotetracosahydro-1h-dipyrrolo[2,1-c:2',1'-l][1,4,7,10,13,16]hexaazacyclohenicosin-9-yl}-4''-(pentyloxy)-1,1':4',1''-terphenyl-4-carboxamide

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 1140.2 g/mol
    Molecular Formula C58H73N7O17
    XLogP32.3
    Hydrogen Bond Donor Count14
    Hydrogen Bond Acceptor Count17
    Rotatable Bond Count14
    Exact Mass1139.50629389 g/mol
    Monoisotopic Mass1139.50629389 g/mol
    Topological Polar Surface Area377 Ų
    Heavy Atom Count82
    Formal Charge0
    Complexity2150
    Isotope Atom Count0
    Defined Atom Stereocenter Count15
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameEraxis
    PubMed HealthAnidulafungin (Injection)
    Drug ClassesAntifungal
    Drug LabelERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is...
    Active IngredientAnidulafungin
    Dosage FormInjectable
    Routeinjection; Iv (infusion)
    Strength100mg/vial; 50mg; 50mg/vial
    Market StatusPrescription
    CompanyPfizer; Vicuron

    2 of 2  
    Drug NameEraxis
    PubMed HealthAnidulafungin (Injection)
    Drug ClassesAntifungal
    Drug LabelERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is...
    Active IngredientAnidulafungin
    Dosage FormInjectable
    Routeinjection; Iv (infusion)
    Strength100mg/vial; 50mg; 50mg/vial
    Market StatusPrescription
    CompanyPfizer; Vicuron

    4.2 Drug Indication

    For use in the treatment of the following fungal infections: Candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis), Aspergillus infections, and esophageal candidiasis. Also considered an alternative treatment for oropharyngeal canaidiasis.

    FDA Label

    Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Anidulafungin is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. Anidulafungin is active in vitro against many Candida, as well as some Aspergillus. Like other echinocandins, anidulafungin is not active against Cryptococcus neoformans, Trichosporon, Fusarium, or zygomycetes.

    5.2 MeSH Pharmacological Classification

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ANIDULAFUNGIN
    5.3.2 FDA UNII
    9HLM53094I
    5.3.3 Pharmacological Classes
    Lipopeptides [CS]; Echinocandin Antifungal [EPC]
    5.4 ATC Code

    J02AX06

    J - Antiinfectives for systemic use

    J02 - Antimycotics for systemic use

    J02A - Antimycotics for systemic use

    J02AX - Other antimycotics for systemic use

    J02AX06 - Anidulafungin

    5.5 Absorption, Distribution and Excretion

    Route of Elimination

    Less than 1% of the administered radioactive dose was excreted in the urine. Anidulafungin is not hepatically metabolized.

    Volume of Distribution

    30 to 50 L

    Clearance

    1 L/h

    5.6 Metabolism/Metabolites

    Hepatic metabolism of anidulafungin has not been observed. Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 (CYP450) isoenzymes. Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ring-opened peptide that lacks antifungal activity.

    5.7 Biological Half-Life

    40-50 hours

    5.8 Mechanism of Action

    Anidulafungin is a semi-synthetic echinocandin with antifungal activity. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall, ultimately leading to osmotic instability and cell death.

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LTD","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"0.08","unit":"KGS","unitRateFc":"150000","totalValueFC":"12152.4","currency":"USD","unitRateINR":"12645000","date":"15-Dec-2023","totalValueINR":"1011600","totalValueInUsd":"12152.4","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"9242875","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"TECHNOLOGY CO LTD BUILDING C25-C28NO.218 XINGHU ROAD, SUZHOU INDUSTRIAL PARK China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718994600,"product":"ANIDULAFUNGIN","address":"Galaxy, Floors 22-24, Plot No. 1, Survey No. 83\/1","city":"HYDERABAD","supplier":"REGEN BIOPHARMA","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"EUGIA STERILES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.71","actualQuantity":"1.707","unit":"KGS","unitRateFc":"230000","totalValueFC":"396469.2","currency":"USD","unitRateINR":"19389000","date":"22-Jun-2024","totalValueINR":"33097023","totalValueInUsd":"396469.2","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"4124363","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"CORPORATE ADDRESS: BUILDING C25-28,NO. 218 XINGHU ROAD, SUZHOU INDUSTRIAL PARK, SUZHOU, JIANGSU, CHINA China","customerAddress":"Galaxy, Floors 22-24, Plot No. 1, Survey No. 83\/1"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731090600,"product":"ANIDULAFUNGIN","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"M\/S.RELIABLE PHARMATECH (TANJIN) CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CAPLIN POINT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"140000","totalValueFC":"28269.4","currency":"USD","unitRateINR":"11928000","date":"09-Nov-2024","totalValueINR":"2385600","totalValueInUsd":"28269.4","indian_port":"Madras Air","hs_no":"29420090","bill_no":"6591549","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ZUOANMINGDI XIANSHUIGU JINNAN DISTRICT TIANJIN 300350 CN","customerAddress":"NARBAVI, NO.3,LAKSHMANAN STREET,"}]
    01-Jul-2022
    09-Nov-2024
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    ABOUT THIS PAGE

    Looking for 166663-25-8 / Anidulafungin API manufacturers, exporters & distributors?

    Anidulafungin manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Anidulafungin 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 Anidulafungin manufacturer or Anidulafungin supplier for your needs.

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

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

    API | Excipient name

    Anidulafungin

    Synonyms

    Eraxis, 166663-25-8, Ecalta, V-echinocandin, Ver-002, Ly303366

    Cas Number

    166663-25-8

    Unique Ingredient Identifier (UNII)

    9HLM53094I

    About Anidulafungin

    Echinocandin antifungal agent that is used in the treatment of CANDIDEMIA and CANDIDIASIS.

    Ecalta Manufacturers

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

    Ecalta Suppliers

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

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

    Ecalta USDMF

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

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

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

    Ecalta KDMF

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

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

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

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

    Ecalta WC

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

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

    Ecalta 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 Ecalta as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ecalta GMP

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

    Ecalta CoA

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

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

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