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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
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
| Molecular Weight | 209.11 g/mol |
|---|---|
| Molecular Formula | C8H14Cl2N2 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 3 |
| Exact Mass | 208.0534038 g/mol |
| Monoisotopic Mass | 208.0534038 g/mol |
| Topological Polar Surface Area | 24.9 Ų |
| Heavy Atom Count | 12 |
| Formal Charge | 0 |
| Complexity | 83.3 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
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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Certificate Number : CEP 2009-177 - Rev 03
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 1665
Status : Valid
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-11-12
Registration Number : 20220916-211-J-1364(A)
Manufacturer Name : LABORATORIOS ESPINOS Y BOFILL SA (LEBSA)
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
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Certificate Number : CEP 2013-240 - Rev 02
Issue Date : 2024-07-09
Type : Chemical
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Date of Issue : 2025-09-18
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Substance Number : 1665
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Written Confirmation Number : WC-0054
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Drugs in Development
Details:
Betahistine dihydrochloride is an antivertigo agent, which is act as the histamine receptor inhibitor, which is indicated for the reduction of recurrent vertigo episodes associated with Meniere's disease in patients 18 years old and above.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Betahistine Dihydrochloride-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 03, 2023
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Shilpa Medicare Receives UKMHRA Approval for Mouth-dissolving Strips to Treat Illnesses
Details : Betahistine dihydrochloride is an antivertigo agent, which is act as the histamine receptor inhibitor, which is indicated for the reduction of recurrent vertigo episodes associated with Meniere's disease in patients 18 years old and above.
Product Name : Betahistine Dihydrochloride-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 03, 2023
Details:
AM-125 is a patented intranasal formulation of betahistine dihydrochloride. It has been shown to have 5 to 29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 15, 2023
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Altamira Therapeutics Announces IND Clearance by U.S. FDA for AM-125 in Acute Vestibular Syndrome
Details : AM-125 is a patented intranasal formulation of betahistine dihydrochloride. It has been shown to have 5 to 29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 15, 2023
Details:
AM-125 is a patented intranasal formulation of betahistine. It has been shown to have 5-to-29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 12, 2023
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AM-125 is a patented intranasal formulation of betahistine. It has been shown to have 5-to-29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 12, 2023
Details:
AM-125 is a patented intranasal formulation of betahistine dihydrochloride. It has been shown to have 5-to-29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 10, 2023
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AM-125 is a patented intranasal formulation of betahistine dihydrochloride. It has been shown to have 5-to-29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 10, 2023
Details:
In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute peripheral vertigo following neurosurgery. They are randomized to receive either 10 or 20 mg of intranasal betahistine or a placebo three times daily for four weeks.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 14, 2021
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute peripheral vertigo following neurosurgery. They are randomized to receive either 10 or 20 mg of intranasal betahistine or a placebo three times daily for four weeks...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 14, 2021
Details:
First patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 13, 2020
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo
Details : First patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 13, 2020
Details:
Interim analysis of Phase 2 “TRAVERS” trial demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 03, 2020
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Auris Medical Announces Positive Interim Data from TRAVERS Phase 2 Study with AM-125 in Vertigo
Details : Interim analysis of Phase 2 “TRAVERS” trial demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 03, 2020
Details:
Auris Medical Holding completed patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125). The Company expects to release interim results from TRAVERS and commence Part B of the trial in the coming weeks.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 29, 2020
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Auris Medical Holding completed patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125). The Company expects to release interim results from TRAVERS and commence Part B of the trial in the coming ...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 29, 2020
Details:
Last subject had last treatment visit in Phase 1b trial with AM-201 in prevention of antipsychotic-induced weight gain and somnolence; data read-out expected for early May 2020.
Lead Product(s): Betahistine Dihydrochloride,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 05, 2020
Lead Product(s) : Betahistine Dihydrochloride,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Auris Medical Provides Update on Ongoing Clinical Trials with Intranasal Betahistine
Details : Last subject had last treatment visit in Phase 1b trial with AM-201 in prevention of antipsychotic-induced weight gain and somnolence; data read-out expected for early May 2020.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 05, 2020
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Application Number :
Registration Country : Egypt
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : SR Tablet
Dosage Strength : 16MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : SR Tablet
Dosage Strength : 16MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic CTD, BE- Available
Registration Country : Jordan
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic CTD, BE- Available
Registration Country : Jordan
Regulatory Info :
Registration Country : U.A.E
Brand Name : Mevetin
Dosage Form : Tablet
Dosage Strength : 16MG
Packaging : 6x10's
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.A.E
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Oral Disintegrating/Di...
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage : Oral Disintegrating/Di...
Dosage Strength : 8MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
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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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
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