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2 EU WC
2 NDC API
6 Listed Suppliers
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51 Drugs in Development

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33 Intermediates Suppliers

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17 FDF Dossiers, 6 Europe, 7 Australia, 2 South Africa, 2 Listed Dossiers

17 FDF Dossiers
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7 Australia
2 South Africa
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1 US Medicaid Prescriptions, 6 Finished Drug Prices, 13 Annual Reports

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13 Annual Reports

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1 APIs, 1 FDF Dossiers

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Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

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CEP/COS

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KDMF

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$ 35,768

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625,976,421

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11,840

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137 RELATED EXCIPIENT COMPANIES

247EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 417716-92-8, E7080, 4-(3-chloro-4-(3-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide, E7080 (lenvatinib), Lenvatinib (e7080), E-7080

Molecular Formula

C₂₁H₁₉ClN₄O₄

Molecular Weight

426.9 g/mol

InChI Key

WOSKHXYHFSIKNG-UHFFFAOYSA-N

FDA UNII

EE083865G2

Lenvatinib is a synthetic, orally available inhibitor of vascular endothelial growth factor receptor 2 (VEGFR2, also known as KDR/FLK-1) tyrosine kinase with potential antineoplastic activity. Lenvatinib blocks VEGFR2 activation by VEGF, resulting in inhibition of the VEGF receptor signal transduction pathway, decreased vascular endothelial cell migration and proliferation, and vascular endothelial cell apoptosis.

Lenvatinib is a Kinase Inhibitor. The mechanism of action of lenvatinib is as a Receptor Tyrosine Kinase Inhibitor.

1 2D Structure

Lenvatinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[3-chloro-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxyquinoline-6-carboxamide

2.1.2 InChI

InChI=1S/C21H19ClN4O4/c1-29-19-10-17-13(9-14(19)20(23)27)18(6-7-24-17)30-12-4-5-16(15(22)8-12)26-21(28)25-11-2-3-11/h4-11H,2-3H2,1H3,(H2,23,27)(H2,25,26,28)

2.1.3 InChI Key

WOSKHXYHFSIKNG-UHFFFAOYSA-N

2.1.4 Canonical SMILES

COC1=CC2=NC=CC(=C2C=C1C(=O)N)OC3=CC(=C(C=C3)NC(=O)NC4CC4)Cl

2.2 Other Identifiers

2.2.1 UNII

EE083865G2

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4-(3-chloro-4-(((cyclopropylamino)carbonyl)amino)phenoxy)-7-hydroxy-6-quinolinecarboxamide

2. 4-(3-chloro-4-((cyclopropylaminocarbonyl)amino)phenoxy)-7-methoxy-6-quinolinecarboxamide

3. 4-(3-chloro-4-(n'-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide

4. E 7080

5. E-7080

6. E-7080 Mesylate

7. E7080

8. E7080 Mesylate

9. Er-203492-00

10. Lenvatinib Mesilate

11. Lenvatinib Mesylate

12. Lenvatinib Metabolite M2

13. Lenvatinib Methanesulfonate

14. Lenvima

15. N-(4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)-n'-cyclopropylurea Monomethanesulfonate

2.3.2 Depositor-Supplied Synonyms

1. 417716-92-8

2. E7080

3. 4-(3-chloro-4-(3-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide

4. E7080 (lenvatinib)

5. Lenvatinib (e7080)

6. E-7080

7. E 7080

8. Er-203492-00

9. Lenvatinib Free Base

10. Unii-ee083865g2

11. 4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide

12. 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide

13. 4-[3-chloro-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxyquinoline-6-carboxamide

14. Chembl1289601

15. Chebi:85994

16. 417716-92-8 (free Base)

17. Ee083865g2

18. 4-(3-chloro-4-(n'-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide

19. 4-(3-chloro-4-((cyclopropylaminocarbonyl)amino)phenoxy)-7-methoxy-6-quinolinecarboxamide

20. 4-[3-chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide

21. Lenvatinib [usan]

22. Lenvatinib [usan:inn]

23. Kisplyx

24. 4-(3-chloro-4-((cyclopropylcarbamoyl)amino)phenoxy)-7-methoxyquinoline-6-carboxamide

25. 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide

26. Lev

27. Lenvatinib; E7080

28. Lenvatinib [mi]

29. Lenvatinib Base- Bio-x

30. Lenvatinib [inn]

31. Lenvatinib (usan/inn)

32. Lenvatinib [who-dd]

33. Mls006011239

34. Schembl864638

35. Gtpl7426

36. Amy9240

37. Dtxsid50194605

38. Ex-a249

39. Bcpp000247

40. Hms3244a07

41. Hms3244a08

42. Hms3244b07

43. Hms3654a14

44. Bcp01799

45. Zinc3816292

46. Bdbm50331094

47. Mfcd16038644

48. Nsc755980

49. Nsc800781

50. S1164

51. Akos025401742

52. Bcp9000633

53. Ccg-264842

54. Cs-0109

55. Db09078

56. Nsc-755980

57. Nsc-800781

58. Sb16580

59. Ncgc00263198-01

60. Ncgc00263198-04

61. Ncgc00263198-07

62. Ac-25047

63. As-16203

64. Bl164616

65. Hy-10981

66. Smr004702999

67. Db-070219

68. Ft-0700727

69. Sw219259-1

70. D09919

71. 716c928

72. A825653

73. J-513372

74. Q6523413

75. Brd-k39974922-001-02-7

76. 4-[3-chloranyl-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxy-quinoline-6-carboxamide

77. N-(4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)-n'-cyclopropylurea

78. 4-[3-chloro-4-[[(cyclopropylamino)-oxomethyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide

79. 6-quinolinecarboxamide, 4-(3-chloro-4- (((cyclopropylamino)carbonyl)amino)phenoxy)-7-methoxy-

80. 6-quinolinecarboxamide, 4-(3-chloro-4-(((cyclopropylamino)carbonyl)amino)phenoxy)- 7-methoxy-

81. 6-quinolinecarboxamide, 4-(3-chloro-4-(((cyclopropylamino)carbonyl)amino)phenoxy)-7-methoxy-

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₁₉ClN₄O₄
Molecular Weight	426.9 g/mol
XLogP3	2.8
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	6
Exact Mass	426.1094828 g/mol
Monoisotopic Mass	426.1094828 g/mol
Topological Polar Surface Area	116 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	634
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

4 Drug and Medication Information

4.1 Drug Indication

Lenvatinib is indicated for the treatment of following conditions. - Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. - Treatment of advanced renal cell carcinoma (RCC) in combination with everolimus following one prior antiangiogenic therapy. - First-line treatment of unresectable hepatocellular carcinoma (HCC).

FDA Label

Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hrthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.

Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC):

- in combination with pembrolizumab, as first-line treatment (see section 5. 1).

- in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.

Treatment of follicular thyroid cancer , Treatment of osteosarcoma, Treatment of papillary thyroid cancer

Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thyroid cancer , follicular thyroid cancer and osteosarcoma

5 Pharmacology and Biochemistry

5.1 Pharmacology

Based on x-ray crystallography and kinetic interaction studies, lenvatinib binds to the adenosine 5'-triphosphate binding site of VEGFR2 and to a neighbouring region via a cyclopropane ring and thereby inhibits tyrosine kinase activity and associated signalling pathways.

5.2 MeSH Pharmacological Classification

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.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

LENVATINIB

5.3.2 FDA UNII

EE083865G2

5.3.3 Pharmacological Classes

Receptor Tyrosine Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]

5.4 ATC Code

L01XE

L01XE29

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EX - Other protein kinase inhibitors

L01EX08 - Lenvatinib

5.5 Absorption, Distribution and Excretion

Absorption

Time to peak plasma concentration occurred from 1 to 4 hours postdose. Administration with food did not affect the extent of absorption, but decreased the rate of absorption and delayed the median Tmax from 2 hours to 4 hours.

Route of Elimination

Following administration of a radiolabeled dose, approximately 64% and 25% of the radiolabel were eliminated in the feces and urine, respectively.

5.6 Metabolism/Metabolites

Lenvatinib is metabolized by CYP3A and aldehyde oxidase.

5.7 Biological Half-Life

The terminal elimination halflife of lenvatinib is approximately 28 hours.

5.8 Mechanism of Action

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFR), KIT, and RET.

API SUPPLIERS

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USDMF

01

Msn Laboratories Private Ltd

India

PharmaVenue

Not Confirmed

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EU WC

01

MSN Laboratories

India

PharmaVenue

Not Confirmed

02

MSN Laboratories

India

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Not Confirmed

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NDC API

01

HETERO LABS LIMITED

India

PharmaVenue

Not Confirmed

02

MSN Laboratories Private Limited

India

PharmaVenue

Not Confirmed

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Listed Suppliers

01

Faran Shimi Pharmaceutical

Iran

PharmaVenue

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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Lenvatinib

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.

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02

Cipla

India

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Not Confirmed

03

Fujian South Pharmaceutical

China

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Not Confirmed

04

Hangzhou Longshine Bio-Tech

China

PharmaVenue

Not Confirmed

05

Haoyuan Chemexpress Co.Ltd

China

PharmaVenue

Not Confirmed

Haoyuan Chemexpress Co.Ltd

China

PharmaVenue

Not Confirmed

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China

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lenvatinib

About the Company : Haoyuan Chemexpress Co., Ltd., located in Shanghai Zhangjiang Biomedical Base, is a high-tech company specializing in customized chemical synthesis and R&D of pharmaceutical interm...

Haoyuan Chemexpress Co., Ltd., located in Shanghai Zhangjiang Biomedical Base, is a high-tech company specializing in customized chemical synthesis and R&D of pharmaceutical intermediates and new drugs. The company is mainly engaged in customized synthesis of complex small molecule frameworks and pharmaceutical intermediates, and independent R&D of innovative new drugs; and provides services of production technology improvement and consigned new drug development for pharmaceutical enterprises. Haoyuan Chemexpress is committed to researching and developing APIs and pharmaceutical intermediates with high synthesis technology barriers and difficulties and high added value, and also focuses on the synthesis of chiral compounds.

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06

Shandong Haohong Biotechnology Co.,...

China

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API Reference Price

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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

Lenvatinib Manufacturers

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

Lenvatinib Suppliers

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

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

Lenvatinib USDMF

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

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

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

Lenvatinib WC

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

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

Lenvatinib 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 Lenvatinib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Lenvatinib GMP

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

Lenvatinib CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

8 API Suppliers

1 USDMF

2 EU WC

2 NDC API

6 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

51 Drugs in Development

INTERMEDIATES

33 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

17 FDF Dossiers

6 Europe

7 Australia

2 South Africa

2 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives

38 Fillers, Diluents & Binders

27 Direct Compression

21 Controlled & Modified Release

15 Chewable & Orodispersible Aids

14 Taste Masking

13 Co-Processed Excipients

12 Thickeners and Stabilizers

10 Granulation

9 Film Formers & Plasticizers

7 Disintegrants & Superdisintegrants

5 Empty Capsules

5 Coloring Agents

5 Parenteral

4 Vegetarian Capsules

4 API Stability Enhancers

4 Lubricants & Glidants

3 Solubilizers

3 Topical

2 Emulsifying Agents

2 Rheology Modifiers