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Bendamustine Hydrochloride

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 23 USDMF, 7 JDMF, 10 EU WC, 7 KDMF, 12 NDC API, 26 Listed Suppliers, $ API Reference Price

41 API Suppliers
23 USDMF
7 JDMF
10 EU WC
7 KDMF
12 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

INTERMEDIATES

8 Intermediates Suppliers

8 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers, 39 FDA Orange Book, 30 Europe, 12 Canada, 16 Australia, 8 South Africa, 29 Listed Dossiers

134 FDF Dossiers
39 FDA Orange Book
30 Europe
12 Canada
16 Australia
8 South Africa
29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML), SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML), SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

drugProductComposition
SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 1 Faran Shimi Pharmaceutical, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Actylis, 2 BASF, 1 Clariant, 1 Finar, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

18 Fillers, Diluents & Binders, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Direct Compression, 7 Parenteral, 5 Topical, 4 Co-Processed Excipients, 3 Thickeners and Stabilizers, 3 Disintegrants & Superdisintegrants, 3 Film Formers & Plasticizers, 3 Granulation, 2 Solubilizers, 1 Coating Systems & Additives, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Rheology Modifiers, 1 Emulsifying Agents

excipientsByApplications
18 Fillers, Diluents & Binders
10 Chewable & Orodispersible Aids
9 Taste Masking
9 Direct Compression
7 Parenteral
5 Topical
4 Co-Processed Excipients
3 Thickeners and Stabilizers
3 Disintegrants & Superdisintegrants
3 Film Formers & Plasticizers
3 Granulation
2 Solubilizers
1 Coating Systems & Additives
1 API Stability Enhancers
1 Surfactant & Foaming Agents
1 Rheology Modifiers
1 Emulsifying Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 85 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
85 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 26 Finished Drug Prices, 16 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
26 Finished Drug Prices
16 Annual Reports

MARKET PLACE

5 APIs, 8 FDF Dossiers

marketPlace
5 APIs
8 FDF Dossiers

PATENTS & EXCLUSIVITIES

91 US Patents

patents
91 US Patents

REF. STANDARDS & IMPURITIES

5 USP , 14 Others

otherSolutions
5 USP
14 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 35,952

MARKET PLACE

API

FDF

8INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

134

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

26DRUGS 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)

5,191,131

Annual Reports (USD Million)

4,963

Finished Drug Prices

37 RELATED EXCIPIENT COMPANIES

81EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 3543-75-7, Bendamustine hcl, Treanda, Ribomustin, Cytostasan, Sdx-105

Molecular Formula

C₁₆H₂₂Cl₃N₃O₂

Molecular Weight

394.7 g/mol

InChI Key

ZHSKUOZOLHMKEA-UHFFFAOYSA-N

FDA UNII

981Y8SX18M

A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

1 2D Structure

Bendamustine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydrochloride

2.1.2 InChI

InChI=1S/C16H21Cl2N3O2.ClH/c1-20-14-6-5-12(21(9-7-17)10-8-18)11-13(14)19-15(20)3-2-4-16(22)23;/h5-6,11H,2-4,7-10H2,1H3,(H,22,23);1H

2.1.3 InChI Key

ZHSKUOZOLHMKEA-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CN1C2=C(C=C(C=C2)N(CCCl)CCCl)N=C1CCCC(=O)O.Cl

2.2 Other Identifiers

2.2.1 UNII

981Y8SX18M

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Bendamustin

2. Bendamustine

3. Cytostasan

4. Hydrochloride, Bendamustine

5. Imet 3393

6. Ribomustin

7. Treanda

8. Zimet 3393

2.3.2 Depositor-Supplied Synonyms

1. 3543-75-7

2. Bendamustine Hcl

3. Treanda

4. Ribomustin

5. Cytostasan

6. Sdx-105

7. Bendamustin Hydrochloride

8. Bendeka

9. Imet 3393

10. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzo[d]imidazol-2-yl)butanoic Acid Hydrochloride

11. Syb L-0501

12. Ribomustine

13. Treakisym

14. Bendamustine (hydrochloride)

15. 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic Acid Hydrochloride

16. 97832-05-8

17. Nsc-138783

18. Sdx 105

19. 3543-75-7 (hcl)

20. Sybl-0501

21. 981y8sx18m

22. Levact

23. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzo-[d]imidazol-2-yl)butanoic Acid Hydrochloride

24. 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic Acid;hydrochloride

25. Treanda (tn)

26. 1h-benzimidazole-2-butanoic Acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, Monohydrochloride

27. Bendit

28. Ccris 1864

29. Nsc 138783

30. Cytostosan

31. Innomustine

32. Symbenda

33. Benda

34. Unii-981y8sx18m

35. Treanda Hcl

36. Zimet 33/93

37. Ribomustin (tn)

38. Bendamustine Hydrochloride Injection

39. Vivimusta

40. Inno-p08001

41. Gamma(1-methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid [german]

42. Schembl18843

43. Mls006010156

44. Sdx-105 (cytostasane) Hcl

45. Chembl1201734

46. Dtxsid40188912

47. Bcpp000348

48. Bcp02107

49. Hy-b0077

50. Tox21_500623

51. Mfcd01658758

52. Nsc138783

53. S1212

54. Akos015951203

55. Ac-1619

56. Bcp9000390

57. Bendamustine Hydrochloride (jan/usan)

58. Bendamustine Hydrochloride [mi]

59. Bendamustine Hydrochloride [usan:jan]

60. Ccg-221927

61. Cs-1771

62. Ep-3101

63. Lp00623

64. Sb17462

65. 2-benzimidazolebutyric Acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, Monohydrochloride

66. 2-benzimidazolinebutryric Acid, 1-methyl-5-bis(2-chloroethyl)amino-, Hydrochloride

67. Bendamustine Hydrochloride [jan]

68. Gamma(1-methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid

69. Bendamustine Hydrochloride [usan]

70. Ncgc00261308-01

71. As-15856

72. Bb164239

73. Bendamustine Hydrochloride [mart.]

74. Bp-25399

75. Smr004234484

76. Bendamustine Hydrochloride [usp-rs]

77. Bendamustine Hydrochloride [who-dd]

78. Bendamustine Hcl (sdx-105, Cytostasane)

79. 2-benzimidazolinebutryric Acid, Hydrochloride

80. Am20090666

81. B4033

82. Ft-0650624

83. Ft-0696296

84. Sw219266-1

85. 2-benzimidazolebutyric Acid, Monohydrochloride

86. Bendamustine Hydrochloride [orange Book]

87. D07085

88. Wln: T56 Bn Dnj B1 C3vq Gn2g2g &gh

89. 543b757

90. Bendamustine Hydrochloride [usp Monograph]

91. Q27272066

92. Fmoc-(s)-3-amino-3-(3-trifluoromethyl-phenyl)-propionicacid

93. 4-(5-(bis(2-chloroethyl)amino)-1-methylbenzimidazol-2-yl)butanoic Acid Hcl

94. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzo[d]imidazol-2-yl)butanoicacidhydrochloride

95. 5-[bis(2-chloroethyl)amino]-1-methyl-1h-benzimidazole-2-butanoic Acid Hydrochloride

96. 5-[bis(2-chloroethyl)amino]-1-methylbenzimidazole-2-butyric Acid Hydrochloride

97. 1h-benzimidazole-2-butanoic Acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, Hydrochloride (1:1)

98. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzimidazole-2-yl)butanoic Acid Monohydrochloride

99. 5-[bis(2-chloroethyl)-amino]-1-methyl-1h-benzimidazole-2-butanoic Acid Hydrochloride;ribomustin Hcl

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₂₂Cl₃N₃O₂
Molecular Weight	394.7 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	9
Exact Mass	393.077760 g/mol
Monoisotopic Mass	393.077760 g/mol
Topological Polar Surface Area	58.4 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	380
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Bendamustine hydrochloride
PubMed Health	Bendamustine (Injection)
Drug Classes	Antineoplastic Agent
Drug Label	TREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
Active Ingredient	Bendamustine hydrochloride
Dosage Form	Injectable
Route	injection
Strength	100mg
Market Status	Tentative Approval
Company	Eagle Pharms

2 of 4
Drug Name	Treanda
Drug Label	TREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
Active Ingredient	Bendamustine hydrochloride
Dosage Form	Powder; Injectable; Solution
Route	injection; Iv (infusion)
Strength	25mg/vial; 180mg/2ml (90mg/ml); 45mg/0.5ml (90mg/ml); 100mg/vial; 100mg
Market Status	Prescription
Company	Cephalon

3 of 4
Drug Name	Bendamustine hydrochloride
PubMed Health	Bendamustine (Injection)
Drug Classes	Antineoplastic Agent
Drug Label	TREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
Active Ingredient	Bendamustine hydrochloride
Dosage Form	Injectable
Route	injection
Strength	100mg
Market Status	Tentative Approval
Company	Eagle Pharms

4 of 4
Drug Name	Treanda
Drug Label	TREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
Active Ingredient	Bendamustine hydrochloride
Dosage Form	Powder; Injectable; Solution
Route	injection; Iv (infusion)
Strength	25mg/vial; 180mg/2ml (90mg/ml); 45mg/0.5ml (90mg/ml); 100mg/vial; 100mg
Market Status	Prescription
Company	Cephalon

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antineoplastic Agents, Alkylating

A class of drugs that differs from other alkylating agents used clinically in that they are monofunctional and thus unable to cross-link cellular macromolecules. Among their common properties are a requirement for metabolic activation to intermediates with antitumor efficacy and the presence in their chemical structures of N-methyl groups, that after metabolism, can covalently modify cellular DNA. The precise mechanisms by which each of these drugs acts to kill tumor cells are not completely understood. (From AMA, Drug Evaluations Annual, 1994, p2026) (See all compounds classified as Antineoplastic Agents, Alkylating.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Alkylating Drug [EPC]; Alkylating Activity [MoA]

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

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

iPHEX India

Attending

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

LGM Pharma

U.S.A

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

Antibody Engineering

Not Confirmed

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

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

03

Rochem International Inc

U.S.A

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

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Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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04

Dr. Reddy's Laboratories

India

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

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Beijing Huikang Boyuan Chemical Te...

China

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USDMF

01

Biophore India Pharmaceuticals Pvt L...

India

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Digital Content

Bendamustine Hydrochloride Monohydrate

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-24

Pay. Date : 2013-09-25

DMF Number : 27483

Submission : 2013-09-20

Status : Active

Type : II

02

Dr Reddys Laboratories Ltd

India

CPhI India 2024

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Bendamustine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-03

Pay. Date : 2012-11-29

DMF Number : 24823

Submission : 2011-03-30

Status : Active

Type : II

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API Reference Price

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VAISHNODE","city":"AHMEDABAD","supplier":"EAGLE PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"0.11","actualQuantity":"0.105","unit":"KGS","unitRateFc":"18000","totalValueFC":"2130.4","currency":"USD","unitRateINR":"1675713.1","date":"05-Feb-2023","totalValueINR":"175949.88","totalValueInUsd":"2130.4","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"4503089","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683570600,"product":"BENDAMUSTINE. BATCH NO. 23001AR26V. MAT. 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XX","supplierCountry":"GERMANY","foreign_port":"FRANKFURT AM MAIN","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1000","unit":"GMS","unitRateFc":"102","totalValueFC":"103029.3","currency":"USD","unitRateINR":"8603.7","date":"11-Apr-2024","totalValueINR":"8603700","totalValueInUsd":"103029.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1001350","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT AM MAIN","supplierAddress":"N\/A","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723746600,"product":"BENDAMUSTINE HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"15766.2","totalValueFC":"795.1","currency":"USD","unitRateINR":"1333824","date":"16-Aug-2024","totalValueINR":"66691.2","totalValueInUsd":"795.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"5080172","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"FTO -7, PLOT NO.P1 TO P9 V.S.E.Z., DUVVADA,VISAKHAPATNAM SDNF India","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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India

Medlab Asia & Asia Health

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DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

USFDA APPLICATION NUMBER - 205580

DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

USFDA APPLICATION NUMBER - 208194

DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

USFDA APPLICATION NUMBER - 215033

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01

Brand Name : Bendamustina

United Kingdom

Medlab Asia & Asia Health

Not Confirmed

02

Brand Name : Levact

Japan

Medlab Asia & Asia Health

Not Confirmed

03

Brand Name : Bendamustina

Germany

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Medlab Asia & Asia Health

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers

23 USDMF

7 JDMF

10 EU WC

7 KDMF

12 NDC API

26 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

INTERMEDIATES

8 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers

39 FDA Orange Book

30 Europe

12 Canada

16 Australia

8 South Africa

29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

12 SPI Pharma

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2 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Actylis

2 BASF

1 Clariant

1 Finar

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

2 Kerry

2 Microlex e.U

1 Pluviaendo

3 Roquette

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

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10 Chewable & Orodispersible Aids

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9 Direct Compression

7 Parenteral

5 Topical

4 Co-Processed Excipients

3 Thickeners and Stabilizers

3 Disintegrants & Superdisintegrants

3 Film Formers & Plasticizers

3 Granulation

2 Solubilizers

1 Coating Systems & Additives

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1 Surfactant & Foaming Agents

1 Rheology Modifiers

1 Emulsifying Agents

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85 NEWS #PharmaBuzz

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91 US Patents