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ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 14 USDMF, 2 CEP/COS, 4 JDMF, 16 EU WC, 23 KDMF, 17 NDC API, 39 Listed Suppliers, $ API Reference Price

51 API Suppliers
14 USDMF
2 CEP/COS
4 JDMF
16 EU WC
23 KDMF
17 NDC API
39 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

221 FDF Dossiers, 29 FDA Orange Book, 60 Europe, 39 South Africa, 93 Listed Dossiers

221 FDF Dossiers
29 FDA Orange Book
60 Europe
39 South Africa
93 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 2.5MG/5ML, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
SOLUTION;ORAL - 2.5MG/5ML
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 1 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 10 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 24 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 59 Finished Drug Prices, 7 Annual Reports

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1 US Medicaid Prescriptions
59 Finished Drug Prices
7 Annual Reports

MARKET PLACE

42 APIs, 5 FDF Dossiers

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42 APIs
5 FDF Dossiers

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1 US Patents

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1 US Patents

REF. STANDARDS & IMPURITIES

2 USP , 9 Others

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2 USP
9 Others

ANALYTICAL

4 BioAnalytical Methods

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4 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 660

MARKET PLACE

API

FDF

11INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

221

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS 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)

37,332,215

Annual Reports (USD Million)

474

Finished Drug Prices

211 RELATED EXCIPIENT COMPANIES

328EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 130018-87-0, Xyzal, Xusal, (r)-cetirizine dihydrochloride, Levocetirizine hcl, Levocetirizine dihydrochloride [usan]

Molecular Formula

C₂₁H₂₇Cl₃N₂O₃

Molecular Weight

461.8 g/mol

InChI Key

PGLIUCLTXOYQMV-GHVWMZMZSA-N

FDA UNII

SOD6A38AGA

Levocetirizine Dihydrochloride is the dihydrochloride salt form of the active levorotatory enantiomer of cetirizine, levocetirizine; a third generation, non-sedating, selective histamine H1 receptor antagonist, with antihistamine, anti-inflammatory and potential anti-angiogenic activities. Levocetirizine competes with endogenous histamine for binding at peripheral H1-receptor sites on the effector cell surface. This prevents the negative symptoms associated with histamine release and an allergic reaction. In addition, as histamine plays an important role in angiogenesis during an allergic inflammatory reaction, blocking the action of histamine may modulate the expression of proangiogenic factors and thus may prevent angiogenesis. As a third-generation histamine H1 receptor antagonist, levocetirizine has fewer side effects than most second-generation antihistamines.

1 2D Structure

Levocetirizine Dihydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;dihydrochloride

2.1.2 InChI

InChI=1S/C21H25ClN2O3.2ClH/c22-19-8-6-18(7-9-19)21(17-4-2-1-3-5-17)24-12-10-23(11-13-24)14-15-27-16-20(25)26;;/h1-9,21H,10-16H2,(H,25,26);2*1H/t21-;;/m1../s1

2.1.3 InChI Key

PGLIUCLTXOYQMV-GHVWMZMZSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCOCC(=O)O)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl.Cl

2.1.5 Isomeric SMILES

C1CN(CCN1CCOCC(=O)O)[C@H](C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl.Cl

2.2 Other Identifiers

2.2.1 UNII

SOD6A38AGA

2.3 Synonyms

2.3.1 MeSH Synonyms

1. (2-(4-((r)-(4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride

2. (2-(4-((r)-p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid

3. Acetic Acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-

4. Acetic Acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride

5. Cetirizine (r)-form Dihydrochloride

6. Levocetirizine

7. Levocetirizine Hydrochloride

8. Levocetrizine

9. Ucb-28556

10. Xusal

11. Xyzal

2.3.2 Depositor-Supplied Synonyms

1. 130018-87-0

2. Xyzal

3. Xusal

4. (r)-cetirizine Dihydrochloride

5. Levocetirizine Hcl

6. Levocetirizine Dihydrochloride [usan]

7. Cetirizine (r)-form Dihydrochloride

8. Ucb-28556

9. Sod6a38aga

10. Ucb 28556

11. (2-(4-((r)-(4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride

12. (r)-2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride

13. Acetic Acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride

14. Nsc-758898

15. Levocetirizine Hydrochloride (jan)

16. (-)-cetirizine Dihydrochloride

17. 2-[2-[4-[(r)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid;dihydrochloride

18. 2-[2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Dihydrochloride

19. Levocetirizine (dihydrochloride)

20. Levocetirizine Hydrochloride [jan]

21. Levocetirizine 2hcl

22. Unii-sod6a38aga

23. Levocetirizine Dihcl

24. Mfcd07366507

25. Xyzal Allergy 24hr

26. Xyzal (tn)

27. Levocetirizinedihydrochloride

28. Schembl144375

29. Chembl1201190

30. Levocetirizine Hydrochloride,(s)

31. Dtxsid30926567

32. Bcp21544

33. Ac-549

34. Levocetirizine Dihydrochloride (usp)

35. S4849

36. Akos015994681

37. Ccg-269359

38. Cs-w011557

39. Hy-w010841

40. Ks-1177

41. Nsc 758898

42. [2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-acetic Acid 2hcl

43. 2-[2-[4-[(r)-(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride

44. Levocetirizine Hydrochloride [mart.]

45. L0264

46. Levocetirizine Dihydrochloride [vandf]

47. Levocetirizine(r)-cetirizine (hydrochloride)

48. D08118

49. Levocetirizine Dihydrochloride [usp-rs]

50. Levocetirizine Dihydrochloride [who-dd]

51. Levocetirizine Dihydrochloride, >=98% (hplc)

52. Cetirizine (r)-form Dihydrochloride [mi]

53. 018l870

54. Levocetirizine Dihydrochloride [orange Book]

55. Levocetirizine Dihydrochloride [usp Monograph]

56. Q27289313

57. [2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-acetic Acid Dihydrochloride

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₇Cl₃N₂O₃
Molecular Weight	461.8 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	8
Exact Mass	460.108726 g/mol
Monoisotopic Mass	460.108726 g/mol
Topological Polar Surface Area	53 Å²
Heavy Atom Count	29
Formal Charge	0
Complexity	443
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Levocetirizine dihydrochloride
Drug Label	Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H1-receptor antagonist. The chemical name is R-(+)-2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydr...
Active Ingredient	Levocetirizine dihydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	2.5mg/5ml; 5mg
Market Status	Prescription
Company	Synthon Pharms; Apotex; Hetero Labs Ltd Iii; Sciegen Pharms; Taro Pharm Inds; Sun Pharma Global; Glenmark Generics; Teva Pharms; Micro Labs Ltd India; Dr Reddys Labs; L Perrigo

2 of 4
Drug Name	Xyzal
PubMed Health	Levocetirizine (By mouth)
Drug Classes	Respiratory Agent
Drug Label	Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride....
Active Ingredient	Levocetirizine dihydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	2.5mg/5ml; 5mg
Market Status	Prescription
Company	Ucb

3 of 4
Drug Name	Levocetirizine dihydrochloride
Drug Label	Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H1-receptor antagonist. The chemical name is R-(+)-2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydr...
Active Ingredient	Levocetirizine dihydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	2.5mg/5ml; 5mg
Market Status	Prescription
Company	Synthon Pharms; Apotex; Hetero Labs Ltd Iii; Sciegen Pharms; Taro Pharm Inds; Sun Pharma Global; Glenmark Generics; Teva Pharms; Micro Labs Ltd India; Dr Reddys Labs; L Perrigo

4 of 4
Drug Name	Xyzal
PubMed Health	Levocetirizine (By mouth)
Drug Classes	Respiratory Agent
Drug Label	Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride....
Active Ingredient	Levocetirizine dihydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	2.5mg/5ml; 5mg
Market Status	Prescription
Company	Ucb

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists, Non-Sedating

A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

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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Metrochem API Private Limited

India

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

Pharmtech & Ingredients

Exhibiting

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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KDMF VMF Others AUDIT

03

Cohance Lifesciences

India

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

CPhI India 2024

Attending

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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India

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DKSH

Switzerland

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

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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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Dr. Reddy's Laboratories

India

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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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Egis Pharmaceuticals PLC

Hungary

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Jai Radhe Sales

India

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India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Octavius Pharma Pvt. Ltd

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API Reference Price

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DOSAGE - SOLUTION;ORAL - 2.5MG/5ML

USFDA APPLICATION NUMBER - 209090

DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22064

DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal ...DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22157

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SOLUTION;ORAL - 2.5MG/5ML

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 Novo Excipients

1 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

17 Roquette

12 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

2 The Dow Chemical Company

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders

47 Coating Systems & Additives

24 Thickeners and Stabilizers

24 Controlled & Modified Release

23 Direct Compression

15 Disintegrants & Superdisintegrants

15 Solubilizers

14 Film Formers & Plasticizers

14 Granulation

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;ORAL - 2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons