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    Chemistry

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    Also known as: Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)
    Molecular Formula
    C18H20ClN3O
    Molecular Weight
    329.8  g/mol
    InChI Key
    MKBLHFILKIKSQM-UHFFFAOYSA-N
    FDA UNII
    2999F27MAD
    Ondansetron Hydrochloride
    A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
    1 2D Structure

    Ondansetron Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C18H19N3O.ClH/c1-12-19-9-10-21(12)11-13-7-8-16-17(18(13)22)14-5-3-4-6-15(14)20(16)2;/h3-6,9-10,13H,7-8,11H2,1-2H3;1H
    2.1.3 InChI Key
    MKBLHFILKIKSQM-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    2999F27MAD
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-

    2. Dihydrate, Ondansetron Monohydrochloride

    3. Gr 38032f

    4. Gr-38032f

    5. Gr38032f

    6. Hydrochloride, Ondansetron

    7. Monohydrochloride Dihydrate, Ondansetron

    8. Monohydrochloride, Ondansetron

    9. Odt, Zofran

    10. Ondansetron

    11. Ondansetron Monohydrochloride

    12. Ondansetron Monohydrochloride Dihydrate

    13. Ondansetron, (+,-)-isomer

    14. Ondansetron, (r)-isomer

    15. Ondansetron, (s)-isomer

    16. Sn 307

    17. Sn-307

    18. Sn307

    19. Zofran

    20. Zofran Odt

    2.3.2 Depositor-Supplied Synonyms

    1. Ondansetron Hcl

    2. 99614-01-4

    3. Zofran

    4. Ondemet

    5. Emeset

    6. Ondansetron (hydrochloride)

    7. Zofran Odt

    8. Nsc 665799

    9. Ondansetronhydrochloride

    10. 2999f27mad

    11. Nsc-665799

    12. C18h20cln3o

    13. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-, Monohydrochloride

    14. Emetron

    15. 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-4h-carbazol-4-one Hydrochloride

    16. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4h-carbazol-4-one Hydrochloride

    17. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-2,3-dihydro-1h-carbazol-4(9h)-one Hydrochloride

    18. Smr000469179

    19. Gr 38032

    20. Unii-2999f27mad

    21. Sr-01000763250

    22. Zofran Preservative Free

    23. Zofran And Dextrose In Plastic Container

    24. Cpd000469179

    25. Ondansetron Hydrochloride Preservative Free

    26. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-4h-carbazol-4-one Monohydrochloride

    27. Schembl41455

    28. Mls001304076

    29. Mls001401397

    30. Mls002222312

    31. Regid_for_cid_68647

    32. Gr 38032 Hcl

    33. Ondansetron Hydrochloride, 98%

    34. Chembl1201111

    35. Ondansetron Hydrochloride- Bio-x

    36. Ondansetron Hydrochloride And Dextrose In Plastic Container

    37. Dtxsid701027913

    38. Hms1571c18

    39. Ondansetron Hydrochloride (zofran)

    40. Hy-b0002

    41. Ondansetron Hydrochloride And Sodium Chloride In Plastic Container

    42. Mfcd00764297

    43. Nsc665799

    44. S1390

    45. Ondansetron Hydrochloride [mi]

    46. Akos015889292

    47. Ab07046

    48. Ccg-100852

    49. Ccg-221058

    50. Cs-1715

    51. Gs-3597

    52. H39o049

    53. Nc00102

    54. Ac-12464

    55. Bo164177

    56. Ondansetron Hydrochloride [who-dd]

    57. Ondansetron Hydrochloride Anhydrous

    58. O0407

    59. Sw100810-5

    60. Vu0424014-2

    61. C90628

    62. (+/-)-ondansetron Hydrochloride Anhydrous

    63. A800774

    64. Ondansetron Hydrochloride Anhydrous, (+/-)-

    65. Q-201515

    66. Sr-01000763250-5

    67. Q27254405

    68. 9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1h-carbazol-4-one;hydrochloride

    69. 1,2,3,4-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-9h-carbazol-4-one Hydrochloride

    70. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-, Hydrochloride (1:1)

    71. 9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1h-carbazol-4-one Hydrochloride

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 329.8 g/mol
    Molecular Formula C18H20ClN3O
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count2
    Exact Mass329.1294900 g/mol
    Monoisotopic Mass329.1294900 g/mol
    Topological Polar Surface Area39.8 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity440
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameOndansetron hydrochloride
    Drug LabelThe active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (1, 2, 3, 9-te...
    Active IngredientOndansetron hydrochloride
    Dosage FormTablet; Injectable; Solution
    Routeoral; Injection; Oral
    Strengtheq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base
    Market StatusTentative Approval; Prescription
    CompanyAmneal Pharms; Wockhardt; Silarx; Bedford; Hospira; Gland Pharma; Sun Pharm Inds (in); Teva; Apotex; Hikma Farmaceutica; Aurobindo Pharma; Natco Pharma; Taro; Sandoz; Par Pharm; Roxane; Glenmark Generics; Emcure Pharms; Fresenius Kabi Usa; Ipca Labs; Hikm

    2 of 6  
    Drug NameOndansetron hydrochloride preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyWockhardt; Hospira; Teva; Hikma Farmaceutica; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Hikma Maple; Claris Lifesciences; Taro Pharms Ireland; Luitpold; Bedford Labs; Agila Speclts; Bd Rx

    3 of 6  
    Drug NameZofran preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyGlaxosmithkline

    4 of 6  
    Drug NameOndansetron hydrochloride
    Drug LabelThe active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (1, 2, 3, 9-te...
    Active IngredientOndansetron hydrochloride
    Dosage FormTablet; Injectable; Solution
    Routeoral; Injection; Oral
    Strengtheq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base
    Market StatusTentative Approval; Prescription
    CompanyAmneal Pharms; Wockhardt; Silarx; Bedford; Hospira; Gland Pharma; Sun Pharm Inds (in); Teva; Apotex; Hikma Farmaceutica; Aurobindo Pharma; Natco Pharma; Taro; Sandoz; Par Pharm; Roxane; Glenmark Generics; Emcure Pharms; Fresenius Kabi Usa; Ipca Labs; Hikm

    5 of 6  
    Drug NameOndansetron hydrochloride preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyWockhardt; Hospira; Teva; Hikma Farmaceutica; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Hikma Maple; Claris Lifesciences; Taro Pharms Ireland; Luitpold; Bedford Labs; Agila Speclts; Bd Rx

    6 of 6  
    Drug NameZofran preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyGlaxosmithkline

    4.2 Drug Indication

    Treatment of alcohol use disorder

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Serotonin 5-HT3 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)

    Antipruritics

    Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

    Antiemetics

    Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin-3 Receptor Antagonist [EPC]; Serotonin 3 Receptor Antagonists [MoA]

    API Reference Price

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COLTD","customerCountry":"THAILAND","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"320","totalValueFC":"9274.8","currency":"N\/A","unitRateINR":28051.833333333332,"date":"30-Jan-2026","totalValueINR":"841555","totalValueInUsd":"9274.8","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"601","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1769711400,"product":"ONDANSETRON HYDROCHLORIDE DIHYDRATE (PH.EUR)","address":"PLOT NO. 705, ADITYA TRADE CENTRE","city":"HYDERABAD ANDHRA PRADESH","supplier":"SHODHANA LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"TRANSMEC DE BORTOLI GROU","customerCountry":"SPAIN","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"895","totalValueFC":"8600.3","currency":"N\/A","unitRateINR":78035.199999999997,"date":"30-Jan-2026","totalValueINR":"780352","totalValueInUsd":"8600.3","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"35","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. 705, ADITYA TRADE CENTRE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1769711400,"product":"DRUGS: ONDANSETRON HYDROCHLORIDE DIHYDRATE \/ ONDANSETRON HYDROCHLORIDE PH.EUR.","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"IPCA LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"DAMMAM","customer":"TO ORDER OF","customerCountry":"SAUDI ARABIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1110","totalValueFC":"4981.2","currency":"N\/A","unitRateINR":90395,"date":"30-Jan-2026","totalValueINR":"451975","totalValueInUsd":"4981.2","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"48, KANDIVLI INDUSTRIAL ESTATE,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1769797800,"product":"HETEROCYCLIC COMPOUNDS WITH NITROGEN (INV NO.PI\/3052100855 DT:27.01.2026) ORGANIC CHEMICAL:ONDANSETRON HYDROCHLORIDE USP","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"AS PER INVOICE","customerCountry":"PAKISTAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"280","totalValueFC":"265.2","currency":"N\/A","unitRateINR":24060,"date":"31-Jan-2026","totalValueINR":"24060","totalValueInUsd":"265.2","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"0","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710441000,"product":"ONDANSETRON HYDROCHLORIDE(TOXIC SOLID,ORGANIC,N.O.S.)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"CAMBREX CHARLES CITY INC","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO","customer":"PFIZER HEALTHCARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"5285.3","totalValueFC":"319842.5","currency":"USD","unitRateINR":"442639.6","date":"15-Mar-2024","totalValueINR":"26558378","totalValueInUsd":"319842.5","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29332920","bill_no":"1000417","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO","supplierAddress":"1205 11TH STREETCHARLES CITY IAUSA","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749407400,"product":"TOXIC SOLID, ORGANIC, N.O.S (ONDANSETRON HYDROCHLORIDE)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"CAMBREX CHARLES CITY INC","supplierCountry":"UNITED STATES","foreign_port":"CHARLES TOWN","customer":"PFIZER HEALTHCARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"85.09","actualQuantity":"85.087","unit":"KGS","unitRateFc":"5283.2","totalValueFC":"453843.9","currency":"USD","unitRateINR":"458315.9","date":"09-Jun-2025","totalValueINR":"38996726.59","totalValueInUsd":"453843.9","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29332920","bill_no":"2544257","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHARLES TOWN","supplierAddress":"1205 11 STREET CHARLES CITY IA SDNF UNITED STATES","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1763922600,"product":"TOXIC SOLID, ORGANIC, N.O.S (ONDANSETRON HYDROCHLORIDE)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"CAMBREX CHARLES CITY INC","supplierCountry":"UNITED STATES","foreign_port":"CHARLESTOWN","customer":"PFIZER HEALTHCARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"174.36","actualQuantity":"174.36","unit":"KGS","unitRateFc":"5269.8","totalValueFC":"925234.7","currency":"USD","unitRateINR":"471643.6","date":"24-Nov-2025","totalValueINR":"82235778.15","totalValueInUsd":"925234.7","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29332920","bill_no":"2","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHARLESTOWN","supplierAddress":"1205 11 STREET CHARLES CITY IA SDNF UNITED STATES","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"}]
    12-Jan-2022
    31-Jan-2026
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20007

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    DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20103

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    DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20103

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    DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20103

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    DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20605

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    ABOUT THIS PAGE

    Looking for 99614-01-4 / Ondansetron Hydrochloride API manufacturers, exporters & distributors?

    Ondansetron Hydrochloride manufacturers, exporters & distributors 1

    43

    PharmaCompass offers a list of Ondansetron Hydrochloride 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 Ondansetron Hydrochloride manufacturer or Ondansetron Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Ondansetron Hydrochloride

    Synonyms

    Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)

    Cas Number

    99614-01-4

    Unique Ingredient Identifier (UNII)

    2999F27MAD

    About Ondansetron Hydrochloride

    A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

    Zensana Manufacturers

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

    Zensana Suppliers

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

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

    Zensana USDMF

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

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

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

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

    Zensana KDMF

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

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

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

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

    Zensana CEP

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

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

    Zensana WC

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

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

    Zensana 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 Zensana as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Zensana GMP

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

    Zensana CoA

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

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

    Zensana may be tested according to a variety of international standards, such as European Pharmacopoeia (Zensana EP), Zensana JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zensana 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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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

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