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Chemistry

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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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Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720809000,"product":"BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"OLON SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"IND SWIFT LIMITED","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"235","totalValueFC":"64484.3","currency":"EUR","unitRateINR":"21561.3","date":"13-Jul-2024","totalValueINR":"5390312.5","totalValueInUsd":"64484.3","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"4485840","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":"Q3","strtotime":1722018600,"product":"BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"OLON SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"IND SWIFT LIMITED","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"235","totalValueFC":"65152","currency":"EUR","unitRateINR":"21784.5","date":"27-Jul-2024","totalValueINR":"5446125","totalValueInUsd":"65152","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"4731012","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":"Q4","strtotime":1734114600,"product":"BETAHISTINE DIHYDROCHLORIDE BETAHISTINE DIHYDROCHLORIDE","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"OLON SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"IND SWIFT 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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739557800,"product":"BETAHISTINE DIHYDROCHLORIDE PH EUR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"N\/A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"312.5","totalValueFC":"7941.4","currency":"EUR","unitRateINR":"27624.6","date":"15-Feb-2025","totalValueINR":"690615","totalValueInUsd":"7941.4","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"8375573","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"}]
11-Jan-2022
30-Apr-2025
KGS
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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

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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
PharmaVenue
Not Confirmed
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Mepha Pharma AG

Switzerland
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PharmaVenue
Not Confirmed

Betahistini dihydrochloridum

Brand Name : Betahistin-Mepha 16

Dosage Form : Tabl

Dosage Strength : 16mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

MYLAN SpA

U.S.A
PharmaVenue
Not Confirmed
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MYLAN SpA

U.S.A
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PharmaVenue
Not Confirmed

Betahistine

Brand Name : Betahistine

Dosage Form :

Dosage Strength : 30 Cpr 16 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

Betahistini dihydrochloridum

Brand Name : Betaserc

Dosage Form : Tabl

Dosage Strength : 8mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

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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05

Hennig Arzneimittel GmbH & Co. KG

Country
PharmaVenue
Not Confirmed
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Hennig Arzneimittel GmbH & Co. KG

Country
arrow
PharmaVenue
Not Confirmed

betahistindihydroklorid

Brand Name : Vertisan

Dosage Form : TABLETT

Dosage Strength : 8 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

C.T. LAB.FARMACEUTICO Srl

Country
PharmaVenue
Not Confirmed
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C.T. LAB.FARMACEUTICO Srl

Country
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PharmaVenue
Not Confirmed

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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07

SOLVAY PHARMA SpA

Country
PharmaVenue
Not Confirmed
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SOLVAY PHARMA SpA

Country
arrow
PharmaVenue
Not Confirmed

Betahistine

Brand Name : Vertiserc

Dosage Form :

Dosage Strength : 20 Cpr 16 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

Country
PharmaVenue
Not Confirmed
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Country
arrow
PharmaVenue
Not Confirmed

Betahistine

Brand Name : Betahistine Bluefish 16Mg 30 Tablets Efg

Dosage Form : Tablet

Dosage Strength : 16 Mg/Tablet

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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09

Country
PharmaVenue
Not Confirmed
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Country
arrow
PharmaVenue
Not Confirmed

Betahistine

Brand Name : Betahistine Normon 16Mg 30 Tablets Efg

Dosage Form : Tablet

Dosage Strength : 16 Mg/Tablet

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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10

Country
PharmaVenue
Not Confirmed
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Country
arrow
PharmaVenue
Not Confirmed

Betahistine

Brand Name : Betahistine Stada 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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ABOUT THIS PAGE

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

Betahistine Dihydrochloride manufacturers, exporters & distributors 1

41

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.

Vasomotal Manufacturers

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

Vasomotal Suppliers

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

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

Vasomotal USDMF

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

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

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

Vasomotal KDMF

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

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

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

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

Vasomotal CEP

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

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

Vasomotal WC

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

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

Vasomotal 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 Vasomotal as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vasomotal GMP

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

Vasomotal CoA

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

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

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