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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.)

    API Reference Price

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VAISHNODE"},{"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":"Q2","strtotime":1683138600,"product":"CHEMICAL: BETAHISTINE 2HCL PH. EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"LABORATORIOS ESPINOS Y BOFILL SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"171.1","totalValueFC":"25938.8","currency":"USD","unitRateINR":"14229","date":"04-May-2023","totalValueINR":"2134350","totalValueInUsd":"25938.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1001888","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":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 LIMITED","customerCountry":"INDIA","quantity":"16.90","actualQuantity":"16.9","unit":"KGS","unitRateFc":"280","totalValueFC":"5172.6","currency":"EUR","unitRateINR":"25158.3","date":"12-Jun-2023","totalValueINR":"425169.864","totalValueInUsd":"5172.6","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":"Q3","strtotime":1696012200,"product":"BETAHISTINE DIHYDROCHLORIDE IP\/EP, CAS NO. 5579-84-0, BATCHNO. 2350001429","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"240","totalValueFC":"6509","currency":"EUR","unitRateINR":"21612","date":"30-Sep-2023","totalValueINR":"540300","totalValueInUsd":"6509","indian_port":"Delhi Air","hs_no":"29333990","bill_no":"8095832","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STR. RIVOLTANA KM 6\/7,20053 RODANO(MI), ITALYSDNF ITALY","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"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":"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 LIMITED","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":1715538600,"product":"BETAHISTINE DIMESILATE","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"LEBSA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"1800","totalValueFC":"982.7","currency":"EUR","unitRateINR":"163824.6","date":"13-May-2024","totalValueINR":"81912.29","totalValueInUsd":"982.7","indian_port":"Madras Air","hs_no":"29333990","bill_no":"3458189","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CTRA DE L HOSPITALET,3408940 CORNELLA DE LLOBREGATSPAIN SPAIN","customerAddress":"NO 31, RACE COURSE ROAD,BANGALORE"},{"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 LIMITED","customerCountry":"INDIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"313.4","totalValueFC":"3817.9","currency":"EUR","unitRateINR":"28973.8","date":"20-Jun-2024","totalValueINR":"318712.13","totalValueInUsd":"3817.9","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,"}]
    02-Jan-2021
    30-Nov-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    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

    Farmak JSC

    Ukraine
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    Farmak JSC

    Ukraine
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    Regulatory Info :

    Registration Country : Ukraine

    Betahistine

    Brand Name : Vestinorm

    Dosage Form : Tablet

    Dosage Strength : 24MG

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    Approval Date :

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    Regulatory Info :

    Registration Country : Ukraine

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    02

    RATIOPHARM ITALIA Srl

    Germany
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    RATIOPHARM ITALIA Srl

    Germany
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    Regulatory Info :

    Registration Country : Italy

    Betahistine

    Brand Name : Betahistine

    Dosage Form :

    Dosage Strength : 20 Cpr 24 Mg  

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    Regulatory Info :

    Registration Country : Italy

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    03

    MYLAN SpA

    U.S.A
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    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Betahistine

    Brand Name : Betahistine

    Dosage Form :

    Dosage Strength : 20 Cpr 16 Mg  

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    Regulatory Info :

    Registration Country : Italy

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    04

    Viatris Pharma GmbH

    U.S.A
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    Viatris Pharma GmbH

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Betahistini dihydrochloridum

    Brand Name : Betaserc

    Dosage Form : Tabl

    Dosage Strength : 8mg

    Packaging :

    Approval Date :

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    Regulatory Info :

    Registration Country : Switzerland

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    05

    Viatris Pharma GmbH

    U.S.A
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    Viatris Pharma GmbH

    U.S.A
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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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    06

    Hennig Arzneimittel GmbH & Co. KG

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    Registration Country : Sweden

    betahistindihydroklorid

    Brand Name : Vertisan

    Dosage Form : TABLETT

    Dosage Strength : 16 MG

    Packaging :

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    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    07

    PRODOTTI FORMENTI Srl

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    Regulatory Info :

    Registration Country : Italy

    Betahistine

    Brand Name : Microser

    Dosage Form :

    Dosage Strength : 50 Cpr 8 Mg  

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    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    PRODOTTI FORMENTI Srl

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    Regulatory Info :

    Registration Country : Italy

    Betahistine

    Brand Name : Microser

    Dosage Form :

    Dosage Strength : 30 Cpr 16 Mg  

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    Registration Country : Italy

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    09

    Country
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    Regulatory Info :

    Registration Country : Spain

    Betahistine

    Brand Name : Betahistine Normon 8Mg 60 Tablets Efg

    Dosage Form : Tablet

    Dosage Strength : 8 Mg/Tablet

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Spain

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    10

    Country
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    Regulatory Info :

    Registration Country : Spain

    Betahistine

    Brand Name : Fidium 8Mg 60 Tablets

    Dosage Form : Tablet

    Dosage Strength : 8 Mg/Tablet

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Spain

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    ABOUT THIS PAGE

    Betahistine Dihydrochloride Manufacturers

    A Betahistine Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Dihydrochloride, including repackagers and relabelers. The FDA regulates Betahistine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine Dihydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Betahistine Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Betahistine Dihydrochloride Suppliers

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

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

    Betahistine Dihydrochloride USDMF

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

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

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

    Betahistine Dihydrochloride KDMF

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

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

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

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

    Betahistine Dihydrochloride CEP

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

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

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

    Betahistine Dihydrochloride WC

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

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

    Betahistine Dihydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Betahistine Dihydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Betahistine Dihydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Betahistine Dihydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Betahistine Dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betahistine Dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

    Betahistine Dihydrochloride GMP

    Betahistine Dihydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

    Betahistine Dihydrochloride CoA

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

    Betahistine Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Betahistine Dihydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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