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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
    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 Weight 461.8 g/mol
    Molecular Formula C21H27Cl3N2O3
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count8
    Exact Mass460.108726 g/mol
    Monoisotopic Mass460.108726 g/mol
    Topological Polar Surface Area53 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity443
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameLevocetirizine dihydrochloride
    Drug LabelLevocetirizine 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 IngredientLevocetirizine dihydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strength2.5mg/5ml; 5mg
    Market StatusPrescription
    CompanySynthon 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 NameXyzal
    PubMed HealthLevocetirizine (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelLevocetirizine 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 IngredientLevocetirizine dihydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strength2.5mg/5ml; 5mg
    Market StatusPrescription
    CompanyUcb

    3 of 4  
    Drug NameLevocetirizine dihydrochloride
    Drug LabelLevocetirizine 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 IngredientLevocetirizine dihydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strength2.5mg/5ml; 5mg
    Market StatusPrescription
    CompanySynthon 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 NameXyzal
    PubMed HealthLevocetirizine (By mouth)
    Drug ClassesRespiratory Agent
    Drug LabelLevocetirizine 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 IngredientLevocetirizine dihydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strength2.5mg/5ml; 5mg
    Market StatusPrescription
    CompanyUcb

    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]

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PETERSBURG","customer":"UNDISCLOSED","customerCountry":"RUSSIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1050","totalValueFC":"15329.6","currency":"USD","unitRateINR":88520.957333333339,"date":"26-Mar-2025","totalValueINR":"1327814.36","totalValueInUsd":"15329.6","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"9358218","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743100200,"product":"LEVOCETIRIZINE DIHYDROCHLORIDE USP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA LTD","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ARLANDA IMPORTACAO E EXPORTACAO LTD","customerCountry":"BRAZIL","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"850","totalValueFC":"16500.5","currency":"USD","unitRateINR":71461.554499999998,"date":"28-Mar-2025","totalValueINR":"1429231.09","totalValueInUsd":"16500.5","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"9444089","productDescription":"API","marketType":"","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743791400,"product":"LEVOCETIRIZINE DIHYDROCHLORIDE (TAX INVOICE NO: 24-25\/EXP-1198 DT: 27\/03\/2025)","address":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE","city":"HYDERABAD-AP","supplier":"SYMED LABS LTD","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"ABSOLUTE BROKERAGE CUSTOMS SC","customerCountry":"MEXICO","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"570","totalValueFC":"33026.4","currency":"USD","unitRateINR":47118.699999999997,"date":"05-Apr-2025","totalValueINR":"2827122","totalValueInUsd":"33026.4","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"9700243","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE, HYDERABAD-AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745260200,"product":"LEVOCETIRIZINE DIHYDROCHLORIDE PHARMACEUTICAL RAW MATERIALS","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"LINARIA CHEMICALS THAILAND LTD","customerCountry":"THAILAND","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"330","totalValueFC":"3215.8","currency":"USD","unitRateINR":27528.017,"date":"22-Apr-2025","totalValueINR":"275280.17","totalValueInUsd":"3215.8","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"1154089","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747420200,"product":"LEVOCETIRIZINE DIHYDROCHLORIDE (TAX INVOICE NO: 25-26\/EXP-103 DT: 12\/05\/2025)","address":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE","city":"HYDERABAD-AP","supplier":"SYMED LABS LTD","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM PRATTELN BONDED WAREHOUSE","customerCountry":"SWITZERLAND","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"732.6","totalValueFC":"1228.6","currency":"USD","unitRateINR":52339.720000000001,"date":"17-May-2025","totalValueINR":"104679.44","totalValueInUsd":"1228.6","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"1918169","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE, HYDERABAD-AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747852200,"product":"LEVOCETIRIZINE DI HCL USP (BATCH NO.LCTZ\/079\/24-25 MFG. DT. MAR\/2025EXP DT. FEB\/2030)(LEVOCETIRIZINE DIHYDRO","address":"WZ-764-B S\/F KH.NO58\/7\/2&13\/2 GALI","city":"NEW DELHI","supplier":"AVISON PHARMACEUTICALS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"TASHKENT","customer":"FC WELL MED PHARM LLC","customerCountry":"UZBEKISTAN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"212.9","totalValueFC":"1058.4","currency":"USD","unitRateINR":18036.034,"date":"22-May-2025","totalValueINR":"90180.17","totalValueInUsd":"1058.4","indian_port":"JNPT","hs_no":"29335990","bill_no":"2054032","productDescription":"API","marketType":"","country":"UZBEKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"WZ-764-B S\/F KH.NO58\/7\/2&13\/2 GALI, NEW DELHI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652812200,"product":"REIMPORT OF LEVOCETIRIZINE DIHYDROCHLORIDE (BATCH NO. 22LC002)","address":"MAPS HOUSE, 1ST FLOOR, DR.TAKHATASINHJI ROAD,","city":"GUJARAT","supplier":"PHARMANEER CO LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"MAPS LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"570","totalValueFC":"17239.6","currency":"USD","unitRateINR":"44412.6","date":"18-May-2022","totalValueINR":"1332377.49","totalValueInUsd":"17239.6","indian_port":"JNPT","hs_no":"29335990","bill_no":"8727349","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"MAPS HOUSE, 1ST FLOOR, DR.TAKHATASINHJI ROAD,"},{"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 SANAYI TICARET","supplierCountry":"TURKEY","foreign_port":"ISTANBUL","customer":"ALMELO PRIVATE LTD","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":"","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"}]
    05-Jan-2022
    22-May-2025
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    DOSAGE - SOLUTION;ORAL - 2.5MG/5ML

    USFDA APPLICATION NUMBER - 209090

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    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

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    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

    Looking for 130018-87-0 / Levocetirizine Dihydrochloride API manufacturers, exporters & distributors?

    Levocetirizine Dihydrochloride manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Levocetirizine Dihydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier.

    PharmaCompass also assists you with knowing the Levocetirizine Dihydrochloride API Price utilized in the formulation of products. Levocetirizine Dihydrochloride API Price is not always fixed or binding as the Levocetirizine Dihydrochloride Price is obtained through a variety of data sources. The Levocetirizine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Levocetirizine Dihydrochloride

    Synonyms

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

    Cas Number

    130018-87-0

    Unique Ingredient Identifier (UNII)

    SOD6A38AGA

    About Levocetirizine Dihydrochloride

    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.

    Xusal Manufacturers

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

    Xusal Suppliers

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

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

    Xusal USDMF

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

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

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

    Xusal 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 Xusal Drug Master File in Japan (Xusal JDMF) empowers Xusal 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 Xusal JDMF during the approval evaluation for pharmaceutical products. At the time of Xusal 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 Xusal suppliers with JDMF on PharmaCompass.

    Xusal KDMF

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

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

    After submitting a Xusal 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 Xusal API can apply through the Korea Drug Master File (KDMF).

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

    Xusal CEP

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

    A Xusal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xusal 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 Xusal suppliers with CEP (COS) on PharmaCompass.

    Xusal WC

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

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

    Xusal 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 Xusal as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Xusal GMP

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

    Xusal CoA

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

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

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