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19 API Suppliers, 2 USDMF, 2 EU WC, 6 NDC API, 17 Listed Suppliers, $ API Reference Price

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6 NDC API
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20 FDF Dossiers, 3 FDA Orange Book, 8 Europe, 1 Canada, 3 South Africa, 5 Listed Dossiers

20 FDF Dossiers
3 FDA Orange Book
8 Europe
1 Canada
3 South Africa
5 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 1 Faran Shimi Pharmaceutical, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Capital Farma, 3 Actylis, 2 BASF, 5 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 2 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pluviaendo, 3 Roquette, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

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17 Fillers, Diluents & Binders
12 Solubilizers
11 Parenteral
11 Direct Compression
11 Chewable & Orodispersible Aids
10 Taste Masking
5 Co-Processed Excipients
3 Disintegrants & Superdisintegrants
3 Granulation
3 Topical
3 Emulsifying Agents
3 Thickeners and Stabilizers
2 API Stability Enhancers
2 Film Formers & Plasticizers
2 Surfactant & Foaming Agents
1 Rheology Modifiers

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4 Health Canada Patents

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4 Health Canada Patents

Synopsis

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EU WC

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API REF. PRICE (USD/KG)

$ 179,072

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49 RELATED EXCIPIENT COMPANIES

99EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₅₈H₇₃N₇O₁₇
Molecular Weight	1140.2 g/mol
XLogP3	2.3
Hydrogen Bond Donor Count	14
Hydrogen Bond Acceptor Count	17
Rotatable Bond Count	14
Exact Mass	1139.50629389 g/mol
Monoisotopic Mass	1139.50629389 g/mol
Topological Polar Surface Area	377 Å²
Heavy Atom Count	82
Formal Charge	0
Complexity	2150
Isotope Atom Count	0
Defined Atom Stereocenter Count	15
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Eraxis
PubMed Health	Anidulafungin (Injection)
Drug Classes	Antifungal
Drug Label	ERAXIS 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 Ingredient	Anidulafungin
Dosage Form	Injectable
Route	injection; Iv (infusion)
Strength	100mg/vial; 50mg; 50mg/vial
Market Status	Prescription
Company	Pfizer; Vicuron

2 of 2
Drug Name	Eraxis
PubMed Health	Anidulafungin (Injection)
Drug Classes	Antifungal
Drug Label	ERAXIS 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 Ingredient	Anidulafungin
Dosage Form	Injectable
Route	injection; Iv (infusion)
Strength	100mg/vial; 50mg; 50mg/vial
Market Status	Prescription
Company	Pfizer; 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.

API SUPPLIERS

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USDMF

01

Biocon Ltd

India

DDL Conference

Not Confirmed

02

Brightgene Bio-medical Technology Co...

China

DDL Conference

Not Confirmed

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EU WC

01

Concord Biotech

India

DDL Conference

Not Confirmed

02

Gufic Biosciences

India

DDL Conference

Not Confirmed

U.S.A

DDL Conference

Not Confirmed

06

Pliva Croatia Ltd

Croatia

DDL Conference

Not Confirmed

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Listed Suppliers

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API Reference Price

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NO.ANI\/24\/001 MFG DATE :- JUL,2024 ,RE-TEST DATE :- JUN,2027","address":"PLOT NO.B-29\/1 MIDC","city":"MAHAD","supplier":"FLAX LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"DEMO S.A.","customerCountry":"GREECE","quantity":"0.09","actualQuantity":"85","unit":"GMS","unitRateFc":"210","totalValueFC":"17523.8","currency":"USD","unitRateINR":17276.687176470587,"date":"10-Sep-2024","totalValueINR":"1468518.41","totalValueInUsd":"17523.8","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"3905431","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO.B-29\/1 MIDC, MAHAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689100200,"product":"ANIDULAFUNGIN","address":"Ashvich Towers 3rd Floor, No 3, Developed Plots In","city":"Chennai","supplier":"M\/S.SHENZHEN SIJIA PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"CAPLIN POINT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"140000","totalValueFC":"1418.1","currency":"USD","unitRateINR":"11655000.3","date":"12-Jul-2023","totalValueINR":"116550.028","totalValueInUsd":"1418.1","indian_port":"MADRAS AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Ashvich Towers 3rd Floor, No 3, Developed Plots In"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694802600,"product":"ANIDULAFUNGIN","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"SHENZHEN SIJIA PHARMACEUTICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CAPLIN POINT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"0.70","actualQuantity":"0.7","unit":"KGS","unitRateFc":"135000","totalValueFC":"95572.2","currency":"USD","unitRateINR":"11333250","date":"16-Sep-2023","totalValueINR":"7933275","totalValueInUsd":"95572.2","indian_port":"Madras Air","hs_no":"29420090","bill_no":"7867663","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"B305,HUIZHONG MINGYUAN,NO.99DENGLIANG ROAD,NANSHAN DISTRICTSHENZHEN CITY, CHINA 518052 CN","customerAddress":"NARBAVI, NO.3,LAKSHMANAN STREET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706034600,"product":"ANIDULAFUNGIN (CAS NO:166663-25-8)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO.,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.48","actualQuantity":"0.479","unit":"KGS","unitRateFc":"230000","totalValueFC":"111480.1","currency":"USD","unitRateINR":"19343000","date":"24-Jan-2024","totalValueINR":"9265297","totalValueInUsd":"111480.1","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9803306","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BUILDING C26 NO 218 XINGHU ROAD SUZHOU INDUSTRIAL PARK SUZHOU JIANGSU215011 China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710441000,"product":"ANIDULAFUNGIN","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"M\/S.RELIABLE PHARMATECH (TANJIN) CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CAPLIN POINT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"135000","totalValueFC":"163393.4","currency":"USD","unitRateINR":"11306250","date":"15-Mar-2024","totalValueINR":"13567500","totalValueInUsd":"163393.4","indian_port":"Madras Air","hs_no":"29420090","bill_no":"2588453","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ZUOANMINGDI XIANSHUIGU JINNANDISTRICT TIANJIN300350 CN","customerAddress":"NARBAVI, NO.3,LAKSHMANAN STREET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"ANIDULAFUNGIN","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO.,LTD","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"150000","totalValueFC":"7571.5","currency":"USD","unitRateINR":"12690000","date":"30-Sep-2024","totalValueINR":"634500","totalValueInUsd":"7571.5","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"5875048","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BUILDING C25-C28 NO.218 XINGHU ROAD ,SUZHOU INDDUSTRIAL PARK SDNF China","customerAddress":"101, SITARAM MANSION,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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Finished Drug Prices

01

Brand Name : Ecalta

U.S.A

Medlab Asia & Asia Health

Not Confirmed

02

Brand Name : Anidulafungin Accord

United Kingdom

Medlab Asia & Asia Health

Not Confirmed

03

Brand Name : Anidulafungin Labatec

Switzerland

U.S.A

Medlab Asia & Asia Health

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ACTIVE PHARMA INGREDIENTS

19 API Suppliers

2 USDMF

2 EU WC

6 NDC API

17 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

20 FDF Dossiers

3 FDA Orange Book

8 Europe

1 Canada

3 South Africa

5 Listed Dossiers

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5 Gangwal Chemicals

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2 Kerry

2 Microlex e.U

1 Nanjing Bold Chemical

1 Pluviaendo

3 Roquette

6 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders

12 Solubilizers

11 Parenteral

11 Direct Compression

11 Chewable & Orodispersible Aids

10 Taste Masking

5 Co-Processed Excipients

3 Disintegrants & Superdisintegrants

3 Granulation

3 Topical

3 Emulsifying Agents

3 Thickeners and Stabilizers

2 API Stability Enhancers

2 Film Formers & Plasticizers

2 Surfactant & Foaming Agents

1 Rheology Modifiers

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GLOBAL SALES INFORMATION

6 Finished Drug Prices

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6 APIs

1 Intermediates

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 179,072

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

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99EXCIPIENTS BY APPLICATIONS