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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 12 USDMF, 1 JDMF, 9 EU WC, 6 KDMF, 7 NDC API, 35 Listed Suppliers, $ API Reference Price

43 API Suppliers
12 USDMF
1 JDMF
9 EU WC
6 KDMF
7 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

220 FDF Dossiers, 35 FDA Orange Book, 34 Europe, 15 Canada, 90 Australia, 7 South Africa, 39 Listed Dossiers

220 FDF Dossiers
35 FDA Orange Book
34 Europe
15 Canada
90 Australia
7 South Africa
39 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 7 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 1 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 2 Kerry, 3 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 6 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 Sigachi Industries, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

34 Fillers, Diluents & Binders, 15 Direct Compression, 13 Disintegrants & Superdisintegrants, 10 Chewable & Orodispersible Aids, 10 Granulation, 10 Taste Masking, 8 Thickeners and Stabilizers, 8 Lubricants & Glidants, 8 Empty Capsules, 8 Solubilizers, 7 Coating Systems & Additives, 7 Parenteral, 6 Co-Processed Excipients, 5 Film Formers & Plasticizers, 4 Controlled & Modified Release, 3 Coloring Agents, 3 Topical, 2 Emulsifying Agents, 1 Rheology Modifiers, 1 API Stability Enhancers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 61 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 25 Finished Drug Prices, 10 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
25 Finished Drug Prices
10 Annual Reports

MARKET PLACE

16 APIs, 10 FDF Dossiers

marketPlace
16 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 Health Canada Patents

patents
16 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

otherSolutions
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5,833

MARKET PLACE

API

FDF

19INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

220

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

19DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

73,235,347

Annual Reports (USD Million)

7,352

Finished Drug Prices

94 RELATED EXCIPIENT COMPANIES

163EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 341031-54-7, Sutent, Su011248 l-malate salt, Sunitinib malate [usan], Pha-290940ad, Su010398

Molecular Formula

C₂₆H₃₃FN₄O₇

Molecular Weight

532.6 g/mol

InChI Key

LBWFXVZLPYTWQI-IPOVEDGCSA-N

FDA UNII

LVX8N1UT73

An indole and pyrrole derivative that inhibits VEGFR-2 and PDGFR BETA RECEPTOR TYROSINE KINASES. It is used as an antineoplastic agent for the treatment of GASTROINTESTINAL STROMAL TUMORS, and for treatment of advanced or metastatic RENAL CELL CARCINOMA.

1 2D Structure

Sunitinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide;(2S)-2-hydroxybutanedioic acid

2.1.2 InChI

InChI=1S/C22H27FN4O2.C4H6O5/c1-5-27(6-2)10-9-24-22(29)20-13(3)19(25-14(20)4)12-17-16-11-15(23)7-8-18(16)26-21(17)28;5-2(4(8)9)1-3(6)7/h7-8,11-12,25H,5-6,9-10H2,1-4H3,(H,24,29)(H,26,28);2,5H,1H2,(H,6,7)(H,8,9)/b17-12-;/t;2-/m.0/s1

2.1.3 InChI Key

LBWFXVZLPYTWQI-IPOVEDGCSA-N

2.1.4 Canonical SMILES

CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C.C(C(C(=O)O)O)C(=O)O

2.1.5 Isomeric SMILES

CCN(CC)CCNC(=O)C1=C(NC(=C1C)/C=C\2/C3=C(C=CC(=C3)F)NC2=O)C.C([C@@H](C(=O)O)O)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

LVX8N1UT73

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 5-(5-fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1h-pyrrole-3-carboxylic Acid (2-diethylaminoethyl)amide

2. Su 011248

3. Su 11248

4. Su-011248

5. Su-11248

6. Su011248

7. Su11248

8. Sunitinib

9. Sutent

2.3.2 Depositor-Supplied Synonyms

1. 341031-54-7

2. Sutent

3. Su011248 L-malate Salt

4. Sunitinib Malate [usan]

5. Pha-290940ad

6. Su010398

7. Sunitinib L-malate

8. Su-011248 L-malate Salt

9. Lvx8n1ut73

10. Su-010398

11. (z)-n-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (s)-2-hydroxysuccinate

12. Su 11248

13. N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-2-oxo-1h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide;(2s)-2-hydroxybutanedioic Acid

14. Butanedioic Acid, Hydroxy-, (2s)-, Compd. With N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

15. N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (2s)-hydroxybutanedioate

16. (2s)-2-hydroxybutanedioic Acid; N-[2-(diethylamino)ethyl]-5-{[(3z)-5-fluoro-2-oxo-2,3-dihydro-1h-indol-3-ylidene]methyl}-2,4-dimethyl-1h-pyrrole-3-carboxamide

17. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

18. Su 011248

19. Unii-lvx8n1ut73

20. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

21. Mfcd08282795

22. Pdgf Tk Antagonist

23. Sutent (tn)

24. Sunitinib Malate- Bio-x

25. Sutent (tn) (pfizer)

26. Sunitinib Malate (sutent)

27. Chembl1567

28. Su 11248 (malate)

29. Su-11248 L-malate Salt

30. Sunitinib Malate [mi]

31. Sunitinib Malate (jan/usan)

32. Sunitinib Malate [jan]

33. Schembl1258610

34. Schembl1772213

35. Dtxsid4046492

36. Sunitinib Malate [vandf]

37. Sunitinib Malate [mart.]

38. Pnu-290940ad

39. Sunitinib Malate [who-dd]

40. Hms3261h09

41. Sunitinib Malate, >=98% (hplc)

42. Tox21_500514

43. Nsc736511

44. S1042

45. Su-11248j

46. Akos005145765

47. Akos025149097

48. Sunitinib Malate (sunitinib L-malate)

49. Sunitinib Malate [orange Book]

50. Ccg-221818

51. Cs-0177

52. Ks-5023

53. Ncgc00261199-01

54. Bs164428

55. Hy-10255

56. Am20090634

57. Sw219407-1

58. D06402

59. 031s547

60. A822079

61. J-019449

62. Q27283213

63. Sunitinib Malate

64. 341031-54-7

65. Sutent

66. Su-11248

67. Sunitinib

68. (2s)-2-hydroxybutanedioic Acid Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

69. (z)-n-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide(s)-2-hydroxysuccinate

70. 1h-pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-, (2s)-hydroxybutanedioate (1:1)

71. 1h-pyrrole-3-carboxamide,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-, (2s)-hydroxybutanedioate (1:1)

72. 1h-pyrrole-3-carboxamide,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-, Malate Salt

73. Butanedioic Acid, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

74. Butanedioic Acid, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1) (ca Index Name)

75. N-(2-diethylamino)ethyl)-5-((z)-(5-fluoro-2-oxo-1,2-dihydro-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide Hydrogen (2s)-2-hydroxybutanedioate

76. N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidine)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (2s)-2-hydroxybutanedioate Salt

2.4 Create Date

2006-04-29

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₃FN₄O₇
Molecular Weight	532.6 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	10
Exact Mass	532.23332757 g/mol
Monoisotopic Mass	532.23332757 g/mol
Topological Polar Surface Area	172 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	765
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Sunitinib malate
Drug Label	SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)meth...
Active Ingredient	Sunitinib malate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base
Market Status	Prescription
Company	Mylan Pharms

2 of 2
Drug Name	Sunitinib malate
Drug Label	SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)meth...
Active Ingredient	Sunitinib malate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base
Market Status	Prescription
Company	Mylan Pharms

4.2 Drug Indication

* Gastrointestinal stromal tumour (GIST):

Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.

* Metastatic renal cell carcinoma (MRCC):

Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.

* Pancreatic neuroendocrine tumours (pNET):

Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.

Experience with Sutent as first-line treatment is limited (see section 5. 1).

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Angiogenesis Inhibitors

Agents and endogenous substances that antagonize or inhibit the development of new blood vessels. (See all compounds classified as Angiogenesis Inhibitors.)

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Protein Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]

5.3 ATC Code

L01EX01

API SUPPLIERS

01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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02

Gonane Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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03

Faran Shimi Pharmaceutical

Iran

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Iran

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HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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Medichem S.A

Spain

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Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Spain

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USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

06

Shandong Loncom Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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China

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07

Tofigh Daru

Iran

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Not Confirmed

Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.

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08

TAPI Technology & API Services

Israel

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CPhI WW Frankfurt

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TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Shilpa Medicare

India

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10

Sun Pharmaceutical Industries Limi...

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USDMF

01

Medichem Manufacturing Malta Ltd

Spain

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Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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Spain

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Sunitinib Malate

GDUFA

DMF Review : Complete

Rev. Date : 2016-08-11

Pay. Date : 2016-06-02

DMF Number : 30559

Submission : 2016-06-03

Status : Active

Type : II

02

Teva Pharmaceutical Industries Ltd

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

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Sunitinib Malate

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-11-13

DMF Number : 23414

Submission : 2009-12-29

Status : Active

Type : II

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Sun Pharmaceutical Industries Ltd

India

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API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"3211.1","totalValueFC":"38415.5","currency":"USD","unitRateINR":"247414","date":"17-May-2022","totalValueINR":"2968968","totalValueInUsd":"38415.5","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"1000713","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"N\/A","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666895400,"product":"SUNITINIB MALATE","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PVT. 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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"31.00","actualQuantity":"31","unit":"KGS","unitRateFc":"3127","totalValueFC":"98167.7","currency":"USD","unitRateINR":"263606.1","date":"14-Dec-2023","totalValueINR":"8171789","totalValueInUsd":"98167.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"1002281","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"ADD: HF 61,HAL FAR INDUSTRIAL ESTAT E,HAL FAR BBG3000 MALTA Malta","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]

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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ABOUT THIS PAGE

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers

12 USDMF

1 JDMF

9 EU WC

6 KDMF

7 NDC API

35 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

220 FDF Dossiers

35 FDA Orange Book

34 Europe

15 Canada

90 Australia

7 South Africa

39 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

12 SPI Pharma

7 DKSH

4 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

11 BASF

1 DFE Pharma

1 Finar

4 Gangwal Chemicals

2 Ingredion Pharma Solutions

2 Kerry

3 Lonza Capsugel

8 Microlex e.U

1 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

2 Prachin Chemical

1 Qualicaps

6 Roquette

1 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

2 Sigachi Industries

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

34 Fillers, Diluents & Binders

15 Direct Compression

13 Disintegrants & Superdisintegrants

10 Chewable & Orodispersible Aids

10 Granulation

10 Taste Masking

8 Thickeners and Stabilizers

8 Lubricants & Glidants

8 Empty Capsules

8 Solubilizers

7 Coating Systems & Additives

7 Parenteral

6 Co-Processed Excipients

5 Film Formers & Plasticizers

4 Controlled & Modified Release

3 Coloring Agents

3 Topical

2 Emulsifying Agents

1 Rheology Modifiers

1 API Stability Enhancers

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2 DATA COMPILATION #PharmaFlow