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    Also known as: 5579-84-0, Betahistine hydrochloride, Betahistine 2hcl, Betahistine hcl, Serc, Betaserc
    Molecular Formula
    C8H14Cl2N2
    Molecular Weight
    209.11  g/mol
    InChI Key
    XVDFMHARQUBJRE-UHFFFAOYSA-N
    FDA UNII
    49K58SMZ7U
    Betahistine Dihydrochloride
    A histamine analog and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.
    1 2D Structure

    Betahistine Dihydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-methyl-2-pyridin-2-ylethanamine;dihydrochloride
    2.1.2 InChI
    InChI=1S/C8H12N2.2ClH/c1-9-7-5-8-4-2-3-6-10-8;;/h2-4,6,9H,5,7H2,1H3;2*1H
    2.1.3 InChI Key
    XVDFMHARQUBJRE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CNCCC1=CC=CC=N1.Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    49K58SMZ7U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Aequamen

    2. Betahistin Al

    3. Betahistin Ratiopharm

    4. Betahistin Stada

    5. Betahistin-ratiopharm

    6. Betahistine

    7. Betahistine Biphar

    8. Betahistine Dihydrobromide

    9. Betahistine Hydrochloride

    10. Betahistine Mesylate

    11. Betahistine Methanesulfonate

    12. Betahistine Methanesulphonate

    13. Betaserc

    14. Betavert

    15. By Vertin

    16. By-vertin

    17. Dihydrobromide, Betahistine

    18. Dihydrochloride, Betahistine

    19. Extovyl

    20. Fidium

    21. Hydrochloride, Betahistine

    22. Lectil

    23. Melopat

    24. Mersilon

    25. Mesylate, Betahistine

    26. Methanesulfonate, Betahistine

    27. Methanesulphonate, Betahistine

    28. Pt 9

    29. Pt-9

    30. Pt9

    31. Ribrain

    32. Serc

    33. Vasomotal

    34. Vertigon

    2.3.2 Depositor-Supplied Synonyms

    1. 5579-84-0

    2. Betahistine Hydrochloride

    3. Betahistine 2hcl

    4. Betahistine Hcl

    5. Serc

    6. Betaserc

    7. Microser

    8. Antivom

    9. 2-pyridineethanamine, N-methyl-, Dihydrochloride

    10. Betahistine (dihydrochloride)

    11. Pt-9

    12. 2-(2-(methylamino)ethyl)pyridine Dihydrochloride

    13. Betahistine Hydrochloride [usan:usp]

    14. Beta-histine Dihdrochloride

    15. N-methyl-n-(2-pyridin-2-ylethyl)amine Dihydrochloride

    16. 5579-84-0 (hcl)

    17. 49k58smz7u

    18. Methyl[2-(2-pyridyl)ethyl]amine Dihydrochloride

    19. N-methyl-2-pyridin-2-ylethanamine;dihydrochloride

    20. Veserc

    21. Mfcd00012813

    22. N-methyl-2-(pyridin-2-yl)ethanamine Dihydrochloride

    23. Nsc-757397

    24. Methyl[2-(pyridin-2-yl)ethyl]amine Dihydrochloride

    25. Novo-betahistine

    26. Pt 9

    27. Betahistine Hydrochloride [usan]

    28. Einecs 226-966-5

    29. Unii-49k58smz7u

    30. Betahistine Dihcl

    31. Betahistine Di Hcl

    32. Serc (tn)

    33. Beta-histine Dihydrochloride

    34. N-methyl-2-pyridin-2-ylethanamine Dihydrochloride

    35. Schembl60646

    36. Spectrum1500670

    37. Betahistine Hydrochloride ,(s)

    38. Betahistine Hydrochloride (usp)

    39. Chembl1446813

    40. Hy-b0524a

    41. Betahistine Dihydrochloride, 97%

    42. Dtxsid10204355

    43. Amy40800

    44. Bcp13779

    45. Ccg-40327

    46. S3176

    47. Akos015891507

    48. Ks-5298

    49. Nsc 757397

    50. 2-(2-(methylamino)ethyl)pyridine 2hcl

    51. Betahistine Dihydrochloride [mi]

    52. Betahistine Hydrochloride [mart.]

    53. Betahistine Hydrochloride [vandf]

    54. Ncgc00095910-01

    55. Betahistine Hydrochloride [usp-rs]

    56. Betahistine Hydrochloride [who-dd]

    57. Db-052800

    58. Ft-0622911

    59. Ft-0663076

    60. Sw196969-3

    61. En300-31560

    62. 79b840

    63. D03102

    64. Betahistine Hydrochloride [usp Monograph]

    65. A830811

    66. Betahistine Dihydrochloride [ep Monograph]

    67. N-methyl-2-(2-pyridinyl)ethanamine Dihydrochloride

    68. N-methyl-2-(pyridin-2-yl)ethanaminedihydrochloride

    69. N-methyl-2-pyridin-2-yl-ethanamine Dihydrochloride

    70. Q27259291

    71. Betahistine Dihydrochloride, European Pharmacopoeia (ep) Reference Standard

    72. Betahistine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 209.11 g/mol
    Molecular Formula C8H14Cl2N2
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count3
    Exact Mass208.0534038 g/mol
    Monoisotopic Mass208.0534038 g/mol
    Topological Polar Surface Area24.9 Ų
    Heavy Atom Count12
    Formal Charge0
    Complexity83.3
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Histamine Agonists

    Drugs that bind to and activate histamine receptors. Although they have been suggested for a variety of clinical applications histamine agonists have so far been more widely used in research than therapeutically. (See all compounds classified as Histamine Agonists.)

    Vasodilator Agents

    Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

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LIFESCIENCES","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"80","totalValueFC":"482.4","currency":"EUR","unitRateINR":"7156","date":"06-Aug-2021","totalValueINR":"35780","totalValueInUsd":"482.4","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"4956892","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"806\/807,8TH FLOOR, 215 ATRIUM,CHAKALA, ANDHERI KURLA RD."},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1628620200,"product":"BETAHISTINE DI HCL EP ( RE-IMPORT)","address":"2 FLR.PRESTIGE PLAZA40 URMI SOCIETY","city":"AKOTA BARODA","supplier":"JAMJOOM PHARMACEUTICALS COMPANY.","supplierCountry":"INDIA","foreign_port":"","customer":"AMI LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"175","totalValueFC":"7787.3","currency":"USD","unitRateINR":"14439","date":"11-Aug-2021","totalValueINR":"577561.43","totalValueInUsd":"7787.3","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"5005175","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"2 FLR.PRESTIGE PLAZA40 URMI SOCIETY"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645727400,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"65.00","actualQuantity":"65","unit":"KGS","unitRateFc":"280","totalValueFC":"21099.9","currency":"EUR","unitRateINR":"24332","date":"25-Feb-2022","totalValueINR":"1581580","totalValueInUsd":"21099.9","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"7644138","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649788200,"product":"CHEMICAL : BETAHISTINE 2HCI PH.UR","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"LABORATORIOS ESPINOS Y BOFILL S A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"219.8","totalValueFC":"27965.9","currency":"USD","unitRateINR":"16880","date":"13-Apr-2022","totalValueINR":"2110000","totalValueInUsd":"27965.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1001470","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657823400,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"280","totalValueFC":"289.3","currency":"EUR","unitRateINR":"23002","date":"15-Jul-2022","totalValueINR":"23002","totalValueInUsd":"289.3","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"9570068","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657823400,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"44.00","actualQuantity":"44","unit":"KGS","unitRateFc":"280","totalValueFC":"12728","currency":"EUR","unitRateINR":"23002","date":"15-Jul-2022","totalValueINR":"1012088","totalValueInUsd":"12728","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"9570068","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663871400,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"280","totalValueFC":"5646","currency":"EUR","unitRateINR":"22624","date":"23-Sep-2022","totalValueINR":"452480","totalValueInUsd":"5646","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"2578028","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664130600,"product":"8603 BETAHISTINE 2HCL PH.EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"201","totalValueFC":"30246.7","currency":"USD","unitRateINR":"16160","date":"26-Sep-2022","totalValueINR":"2424000","totalValueInUsd":"30246.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29333990","bill_no":"1003982","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664476200,"product":"(RE-IMPORTED) BETAHISTINE DIHYDROCHLORIDE (AS PER INV) (SB NO.4144575 DT.26.08.2021 9071091 DT.03.03.2021)","address":"2ND FLOOR, PRESTIGE PLAZA, 40 URMI NEAR URMI CROSSING, BPC ROAD, AKOTA","city":"VADODARA","supplier":"MAHENDRA LIMITED","supplierCountry":"INDIA","foreign_port":"NA","customer":"AMI LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1025.00","actualQuantity":"1025","unit":"KGS","unitRateFc":"200","totalValueFC":"205662.4","currency":"USD","unitRateINR":"16080","date":"30-Sep-2022","totalValueINR":"16482000","totalValueInUsd":"205662.4","indian_port":"JNPT","hs_no":"29333990","bill_no":"2679361","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"2ND FLOOR, PRESTIGE PLAZA, 40 URMI NEAR URMI CROSSING, BPC ROAD, AKOTA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676313000,"product":"CHEMICAL : BETAHISTINE 2HCI PH.EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"LABORATORIOS ESPINOS Y BOFILL S A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"225.00","actualQuantity":"225","unit":"KGS","unitRateFc":"172","totalValueFC":"38764.1","currency":"USD","unitRateINR":"14229","date":"14-Feb-2023","totalValueINR":"3201525","totalValueInUsd":"38764.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1000641","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682015400,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"280","totalValueFC":"25091.2","currency":"EUR","unitRateINR":"25704","date":"21-Apr-2023","totalValueINR":"2056320","totalValueInUsd":"25091.2","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"5624686","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686508200,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"28.94","actualQuantity":"28.94","unit":"KGS","unitRateFc":"280","totalValueFC":"8857.7","currency":"EUR","unitRateINR":"25158.3","date":"12-Jun-2023","totalValueINR":"728072.821","totalValueInUsd":"8857.7","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697221800,"product":"BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"235","totalValueFC":"37799.9","currency":"EUR","unitRateINR":"20973.8","date":"14-Oct-2023","totalValueINR":"3146062.5","totalValueInUsd":"37799.9","indian_port":"Delhi Air","hs_no":"29333990","bill_no":"8297901","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM6\/7 20090 RODANO(MI) Milano, , ITALY ITALY","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708972200,"product":"BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"235","totalValueFC":"51348.1","currency":"EUR","unitRateINR":"21302.8","date":"27-Feb-2024","totalValueINR":"4260550","totalValueInUsd":"51348.1","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"2321669","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM6\/7 20090 RODANO(MI) Milano, , ITALY ITALY","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712773800,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"313.4","totalValueFC":"5181.9","currency":"EUR","unitRateINR":"28848.5","date":"11-Apr-2024","totalValueINR":"432727.05","totalValueInUsd":"5181.9","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"2975080","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CTRA DE I\\' HOSPITALET, 34 08940 CORNELLA (BARCELONA) Cornella, , SpainSDNF Spain","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712773800,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"313.4","totalValueFC":"17273","currency":"EUR","unitRateINR":"28848.5","date":"11-Apr-2024","totalValueINR":"1442423.5","totalValueInUsd":"17273","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"2975080","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CTRA DE I\\' HOSPITALET, 34 08940 CORNELLA (BARCELONA) Cornella, , SpainSDNF Spain","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716575400,"product":"BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"N\/A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"235","totalValueFC":"45637.3","currency":"EUR","unitRateINR":"21737.5","date":"25-May-2024","totalValueINR":"3804063","totalValueInUsd":"45637.3","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"3668052","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"781, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718821800,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"313.4","totalValueFC":"1388.3","currency":"EUR","unitRateINR":"28973.8","date":"20-Jun-2024","totalValueINR":"115895.32","totalValueInUsd":"1388.3","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"4089924","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CTRA DE I\\' HOSPITALET, 34 08940 CORNELLA (BARCELONA) Cornella, , SpainSDNF Spain","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"BETAHISTINE DIHYDROCHLORIDE, CAS NO. 5579-84-0, BATCH NO. 0024500786","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"8.68","actualQuantity":"8.68","unit":"KGS","unitRateFc":"240","totalValueFC":"2355.4","currency":"EUR","unitRateINR":"22740","date":"11-Sep-2024","totalValueINR":"197383.2","totalValueInUsd":"2355.4","indian_port":"Delhi Air","hs_no":"29333990","bill_no":"5550570","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA RIVOLTANA KM 6\/7,RODANO MI 2 0090 ITITALY SDNF ITALY","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734114600,"product":"BETAHISTINE DIHYDROCHLORIDE BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"249.3","totalValueFC":"50253","currency":"USD","unitRateINR":"21349.8","date":"14-Dec-2024","totalValueINR":"4269950","totalValueInUsd":"50253","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"7235657","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM 6\/7 20090 RODANO(MI) Milano, , ITA LY ITALY","customerAddress":"781, INDUSTRIAL AREA,"}]
    02-Jan-2021
    27-Mar-2025
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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

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    API Imports and Exports

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

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    Europe

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    01

    Mepha Pharma AG

    Switzerland
    PEGS Boston Summit
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    Mepha Pharma AG

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Betahistini dihydrochloridum

    Brand Name : Betahistin-Mepha 24

    Dosage Form : Tabl

    Dosage Strength : 24mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    02

    Mepha Pharma AG

    Switzerland
    PEGS Boston Summit
    Not Confirmed
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    Mepha Pharma AG

    Switzerland
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    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Betahistini dihydrochloridum

    Brand Name : Betahistine-Mepha 16

    Dosage Form : Tabl

    Dosage Strength : 16mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    03

    Viatris Pharma GmbH

    U.S.A
    PEGS Boston Summit
    Not Confirmed
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    Viatris Pharma GmbH

    U.S.A
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    PEGS Boston Summit
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Betahistini dihydrochloridum

    Brand Name : Betaserc

    Dosage Form : Tabl

    Dosage Strength : 24mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    04

    C.T. LAB.FARMACEUTICO Srl

    Country
    PEGS Boston Summit
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    C.T. LAB.FARMACEUTICO Srl

    Country
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    Regulatory Info :

    Registration Country : Italy

    Betahistine

    Brand Name : Sincrover

    Dosage Form :

    Dosage Strength : 50 Cpr 8 Mg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    05

    ANGENERICO SpA

    Country
    PEGS Boston Summit
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    ANGENERICO SpA

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    Betahistine

    Brand Name : Betahistine

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    06

    BB FARMA Srl

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    PEGS Boston Summit
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    Betahistine

    Brand Name : Betahistine

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    Dosage Strength : 20 Cpr 16 Mg  

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    07

    SOLVAY PHARMA SpA

    Country
    PEGS Boston Summit
    Not Confirmed
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    SOLVAY PHARMA SpA

    Country
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    Betahistine

    Brand Name : Vertiserc

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    Dosage Strength : 20 Cpr 16 Mg  

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    Registration Country : Italy

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    08

    Country
    PEGS Boston Summit
    Not Confirmed
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    Country
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    PEGS Boston Summit
    Not Confirmed
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    Registration Country : Spain

    Betahistine

    Brand Name : Betahistine Sandoz 16Mg 30 Tablets Efg

    Dosage Form : Tablet

    Dosage Strength : 16 Mg/Tablet

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    Registration Country : Spain

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    09

    Country
    PEGS Boston Summit
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    Country
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    PEGS Boston Summit
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    Registration Country : Spain

    Betahistine

    Brand Name : Betahistine Bluefish 8Mg 60 Tablets Efg

    Dosage Form : Tablet

    Dosage Strength : 8 Mg/Tablet

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    Registration Country : Spain

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    10

    Country
    PEGS Boston Summit
    Not Confirmed
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    Country
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    PEGS Boston Summit
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    Betahistine

    Brand Name : Betahistine Cinfa 8Mg 60 Tablets Efg

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    Dosage Strength : 8 Mg/Tablet

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    Regulatory Info :

    Registration Country : Spain

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    Canada

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    01

    AURO PHARMA INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    AURO PHARMA INC

    Canada
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    Registration Country : Canada

    BETAHISTINE HYDROCHLORIDE

    Brand Name : AURO-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 16MG

    Packaging :

    Approval Date :

    Application Number : 2449153

    Regulatory Info : Prescription

    Registration Country : Canada

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    02

    AURO PHARMA INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    AURO PHARMA INC

    Canada
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    Registration Country : Canada

    BETAHISTINE HYDROCHLORIDE

    Brand Name : AURO-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 24MG

    Packaging :

    Approval Date :

    Application Number : 2449161

    Regulatory Info : Prescription

    Registration Country : Canada

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    03

    MANTRA PHARMA INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    MANTRA PHARMA INC

    Canada
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    PEGS Boston Summit
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    Regulatory Info : Prescription

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    BETAHISTINE HYDROCHLORIDE

    Brand Name : M-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 8MG

    Packaging :

    Approval Date :

    Application Number : 2519682

    Regulatory Info : Prescription

    Registration Country : Canada

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    04

    MANTRA PHARMA INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    MANTRA PHARMA INC

    Canada
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    PEGS Boston Summit
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    Flag Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    BETAHISTINE HYDROCHLORIDE

    Brand Name : M-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 16MG

    Packaging :

    Approval Date :

    Application Number : 2519690

    Regulatory Info : Prescription

    Registration Country : Canada

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    05

    MANTRA PHARMA INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    MANTRA PHARMA INC

    Canada
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    PEGS Boston Summit
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    Flag Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    BETAHISTINE HYDROCHLORIDE

    Brand Name : M-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 24MG

    Packaging :

    Approval Date :

    Application Number : 2519704

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    Neogen N.V.

    Belgium
    PEGS Boston Summit
    Not Confirmed
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    Neogen N.V.

    Belgium
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    PEGS Boston Summit
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    Flag Belgium
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    Regulatory Info : Generic DCP Ongoing

    Registration Country : Canada

    Betahistine

    Brand Name :

    Dosage Form : TABLET

    Dosage Strength : 24MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Generic DCP Ongoing

    Registration Country : Canada

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    07

    NORA PHARMA INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    NORA PHARMA INC

    Canada
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    PEGS Boston Summit
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    Regulatory Info : Prescription

    Registration Country : Canada

    BETAHISTINE HYDROCHLORIDE

    Brand Name : NRA-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 8MG

    Packaging :

    Approval Date :

    Application Number : 2544911

    Regulatory Info : Prescription

    Registration Country : Canada

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    08

    Pharmascience Inc.

    Canada
    PEGS Boston Summit
    Not Confirmed
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    Pharmascience Inc.

    Canada
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    PEGS Boston Summit
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    Flag Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    Betahistine Dihydrochloride

    Brand Name : PMS-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 16MG

    Packaging : 100 (4X25)

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Canada

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    09

    Pharmascience Inc.

    Canada
    BioProcess International Europe
    Not Confirmed
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    Pharmascience Inc.

    Canada
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    BioProcess International Europe
    Not Confirmed
    • fda
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    Flag Canada
    Virtual Booth Virtual Booth
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    Regulatory Info : Prescription

    Registration Country : Canada

    Betahistine Dihydrochloride

    Brand Name : PMS-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 24MG

    Packaging : 100 TAB(4X25)

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Canada

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    10

    PHARMASCIENCE INC

    Canada
    PEGS Boston Summit
    Not Confirmed
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    PHARMASCIENCE INC

    Canada
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    Flag Canada
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Prescription

    Registration Country : Canada

    BETAHISTINE HYDROCHLORIDE

    Brand Name : PMS-BETAHISTINE

    Dosage Form : TABLET

    Dosage Strength : 16MG

    Packaging : 100 (4X25)

    Approval Date :

    Application Number : 2330210

    Regulatory Info : Prescription

    Registration Country : Canada

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    South Africa

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    01

    Pharmacare Limited, Woodmead

    South Africa
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    BPI Europe
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    • fda
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    Flag South Africa
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine Dihydrochloride

    Brand Name : Menivert 24mg Tablets

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

    Portfolio PDF

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    Website

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    02

    Abbott Laboratories SA (Pty) Ltd

    U.S.A
    BPI Europe
    Not Confirmed
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    Abbott Laboratories SA (Pty) Ltd

    U.S.A
    arrow
    BPI Europe
    Not Confirmed
    • fda
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Originator

    Registration Country : South Africa

    Betahistine

    Brand Name : Serc 24

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    03

    Abbott Laboratories SA (Pty) Ltd

    U.S.A
    BPI Europe
    Not Confirmed
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    Abbott Laboratories SA (Pty) Ltd

    U.S.A
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    BPI Europe
    Not Confirmed
    • fda
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    Flag U.S.A
    Virtual Booth Virtual Booth
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    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine dihydrochloride

    Brand Name : Vertin 24

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    04

    Accord Healthcare (Pty) Ltd

    United Kingdom
    BPI Europe
    Not Confirmed
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    Accord Healthcare (Pty) Ltd

    United Kingdom
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    BPI Europe
    Not Confirmed
    • fda
    • EDQM
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    Flag United Kingdom
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine

    Brand Name : Revihist 24 mg

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    05

    Aurobindo Pharma (Pty) Ltd

    India
    BPI Europe
    Not Confirmed
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    Aurobindo Pharma (Pty) Ltd

    India
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    BPI Europe
    Not Confirmed
    • fda
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine Dihydrochloride

    Brand Name : Hidrist 16 mg Tablets

    Dosage Form : TAB

    Dosage Strength : 16mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    06

    Aurobindo Pharma (Pty) Ltd

    India
    PEGS Boston Summit
    Not Confirmed
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    Aurobindo Pharma (Pty) Ltd

    India
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    PEGS Boston Summit
    Not Confirmed
    • fda
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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine Dihydrochloride

    Brand Name : Dahide 24 mg Tablets

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    07

    Novagen Pharma (Pty) Ltd

    South Africa
    BPI Europe
    Not Confirmed
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    Novagen Pharma (Pty) Ltd

    South Africa
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    BPI Europe
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    Virtual Booth Virtual Booth
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    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine dihydrochloride

    Brand Name : Trevigo 24 mg Tablets

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    08

    Unicorn Pharmaceuticals (Pty) Ltd

    South Africa
    BPI Europe
    Not Confirmed
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    Unicorn Pharmaceuticals (Pty) Ltd

    South Africa
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    BPI Europe
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine Dihydrochloride

    Brand Name : Betahistine 24 Unicorn

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    09

    Zydus Healthcare SA (Pty) Ltd

    India
    BPI Europe
    Not Confirmed
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    Zydus Healthcare SA (Pty) Ltd

    India
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    BPI Europe
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine

    Brand Name : Zygovert

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    10

    Aurogen South Africa (Pty) Ltd

    Country
    BPI Europe
    Not Confirmed
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    Aurogen South Africa (Pty) Ltd

    Country
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    Flag Country
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Betahistine Dihydrochloride

    Brand Name : Hidrist 24 mg Tablets

    Dosage Form : TAB

    Dosage Strength : 24mg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Looking for 5579-84-0 / Betahistine Dihydrochloride API manufacturers, exporters & distributors?

    Betahistine Dihydrochloride manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Betahistine 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 Betahistine Dihydrochloride manufacturer or Betahistine Dihydrochloride supplier for your needs.

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

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

    API | Excipient name

    Betahistine Dihydrochloride

    Synonyms

    5579-84-0, Betahistine hydrochloride, Betahistine 2hcl, Betahistine hcl, Serc, Betaserc

    Cas Number

    5579-84-0

    Unique Ingredient Identifier (UNII)

    49K58SMZ7U

    About Betahistine Dihydrochloride

    A histamine analog and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.

    Aequamen Manufacturers

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

    Aequamen Suppliers

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

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

    Aequamen USDMF

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

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

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

    Aequamen KDMF

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

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

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

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

    Aequamen CEP

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

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

    Aequamen WC

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

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

    Aequamen 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 Aequamen as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Aequamen GMP

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

    Aequamen CoA

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

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

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