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ACTIVE PHARMA INGREDIENTS

53 API Suppliers, 14 USDMF, 2 CEP/COS, 4 JDMF, 16 EU WC, 23 KDMF, 17 NDC API, 41 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers, 29 FDA Orange Book, 60 Europe, 20 South Africa, 94 Listed Dossiers

203 FDF Dossiers
29 FDA Orange Book
60 Europe
20 South Africa
94 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SOLUTION;ORAL - 2.5MG/5ML, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 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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53 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 24 Thickeners and Stabilizers, 24 Controlled & Modified Release, 23 Direct Compression, 15 Solubilizers, 15 Disintegrants & Superdisintegrants, 14 Granulation, 14 Film Formers & Plasticizers, 13 Taste Masking, 13 Co-Processed Excipients, 12 Topical, 12 Parenteral, 11 Lubricants & Glidants, 7 Emulsifying Agents, 5 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Coloring Agents, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 24 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
24 NEWS #PharmaBuzz

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

43 APIs, 5 FDF Dossiers

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43 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents

patents
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)

$ 661

MARKET PLACE

API

FDF

11INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

203

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

209 RELATED EXCIPIENT COMPANIES

327EXCIPIENTS 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

BIO Partnering at JPM

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

BIO Partnering at JPM

Not Confirmed

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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NDC

KDMF VMF Others AUDIT

03

Cohance Lifesciences

India

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

BIO Partnering at JPM

Not Confirmed

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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CEP/COS JDMF EU-WC

NDC

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04

DKSH

Switzerland

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

CPhI WW Frankfurt

Booth #8.0P66

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

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Dr. Reddy's Laboratories

India

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

CPhI WW Frankfurt

Booth #9.1B48

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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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Jai Radhe Sales

India

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Jai Radhe Sales is your partner for all your sourcing needs.

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HRV Global Life Sciences

India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Octavius Pharma Pvt. Ltd

India

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MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Tenatra Chemie

India

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Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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API Reference Price

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REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. 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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0004","unit":"KGS","unitRateFc":"1260000","totalValueFC":"516.8","currency":"USD","unitRateINR":"96221875","date":"25-Nov-2021","totalValueINR":"38488.75","totalValueInUsd":"516.8","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"6405087","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708367400,"product":"LEVOCETIRIZINE DIHYDROCHLORIDE #130018-87-0 \/ BATCH NO: 23H004430","address":"PLOT.NO.A-39 B-11, ROAD.NO.7, IDA","city":"HYDERABAD","supplier":"NEUTEC ILAC SAN TIC A.S","supplierCountry":"TURKEY","foreign_port":"ISTANBUL","customer":"ALMELO","customerCountry":"INDIA","quantity":"29.91","actualQuantity":"29.91","unit":"KGS","unitRateFc":"250","totalValueFC":"8073.8","currency":"USD","unitRateINR":"22397.5","date":"20-Feb-2024","totalValueINR":"669909.78","totalValueInUsd":"8073.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2216498","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"A.S.I.ORGANIZE SANAYI BOLGESI 1.YOLNO:3ADAPAZARI SAKARYASDNF TURKEY","customerAddress":"PLOT.NO.A-39 B-11, ROAD.NO.7, IDA"}]

Number of Transactions

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

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

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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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ABOUT THIS PAGE

Levocetirizine Dihydrochloride Manufacturers

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

Levocetirizine Dihydrochloride Suppliers

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

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

Levocetirizine Dihydrochloride USDMF

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

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

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

Levocetirizine Dihydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Levocetirizine Dihydrochloride Drug Master File in Japan (Levocetirizine Dihydrochloride JDMF) empowers Levocetirizine Dihydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Levocetirizine Dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Levocetirizine Dihydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Levocetirizine Dihydrochloride suppliers with JDMF on PharmaCompass.

Levocetirizine Dihydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Levocetirizine Dihydrochloride Drug Master File in Korea (Levocetirizine Dihydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levocetirizine Dihydrochloride. The MFDS reviews the Levocetirizine Dihydrochloride KDMF as part of the drug registration process and uses the information provided in the Levocetirizine Dihydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Levocetirizine Dihydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Levocetirizine Dihydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Levocetirizine Dihydrochloride suppliers with KDMF on PharmaCompass.

Levocetirizine Dihydrochloride CEP

A Levocetirizine Dihydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Levocetirizine Dihydrochloride Certificate of Suitability (COS). The purpose of a Levocetirizine Dihydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levocetirizine Dihydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levocetirizine Dihydrochloride to their clients by showing that a Levocetirizine Dihydrochloride CEP has been issued for it. The manufacturer submits a Levocetirizine Dihydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levocetirizine Dihydrochloride CEP holder for the record. Additionally, the data presented in the Levocetirizine Dihydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levocetirizine Dihydrochloride DMF.

A Levocetirizine Dihydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levocetirizine Dihydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Levocetirizine Dihydrochloride suppliers with CEP (COS) on PharmaCompass.

Levocetirizine Dihydrochloride WC

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

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

Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Levocetirizine Dihydrochloride GMP

Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride GMP manufacturer or Levocetirizine Dihydrochloride GMP API supplier for your needs.

Levocetirizine Dihydrochloride CoA

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

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

Levocetirizine Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Levocetirizine Dihydrochloride EP), Levocetirizine Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levocetirizine Dihydrochloride 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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ACTIVE PHARMA INGREDIENTS

53 API Suppliers

14 USDMF

2 CEP/COS

4 JDMF

16 EU WC

23 KDMF

17 NDC API

41 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers

29 FDA Orange Book

60 Europe

20 South Africa

94 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**

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EXCIPIENTS BY APPLICATIONS

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47 Coating Systems & Additives

24 Thickeners and Stabilizers

24 Controlled & Modified Release

23 Direct Compression

15 Solubilizers

15 Disintegrants & Superdisintegrants

14 Granulation

14 Film Formers & Plasticizers

13 Taste Masking

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