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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.)
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
| Available Reg Filing : ASMF |
BioXera Pharma: A trusted partner for high-quality human and veterinary APIs and intermediates across global regulated markets.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2013-240 - Rev 02
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 1665
Status : Valid
Date of Issue : 2025-09-18
Valid Till : 2028-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1001
Start Marketing Date : 2015-03-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : CN, BR |
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Certificate Number : CEP 2011-101 - Rev 04
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 1665
Status : Valid
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2025-03-14
Registration Number : 20250205-211-J-1756(1)
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State, India
| Available Reg Filing : BR, MX |
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Registrant Name : Zmax Pharmachem Co., Ltd.
Registration Date : 2022-09-16
Registration Number : 20220916-211-J-1364
Manufacturer Name : LABORATORIOS ESPINOS Y BOFILL SA (LEBSA)
Manufacturer Address : Ctra. De L\'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
| Available Reg Filing : ASMF |
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19593
Submission : 2006-06-23
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36103
Submission : 2021-07-14
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19495
Submission : 2006-06-05
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Certificate Number : CEP 2009-177 - Rev 03
Status : Valid
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 1665
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2013-240 - Rev 02
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 1665
Certificate Number : CEP 2011-101 - Rev 04
Status : Valid
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 1665
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Certificate Number : CEP 2012-058 - Rev 01
Status : Valid
Issue Date : 2023-11-16
Type : Chemical
Substance Number : 1665

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Certificate Number : CEP 2009-001 - Rev 03
Status : Valid
Issue Date : 2025-10-28
Type : Chemical
Substance Number : 1665

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Certificate Number : CEP 2022-505 - Rev 02
Status : Valid
Issue Date : 2025-09-30
Type : Chemical
Substance Number : 1665

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Certificate Number : CEP 2006-316 - Rev 05
Status : Valid
Issue Date : 2024-07-08
Type : Chemical
Substance Number : 1665

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-11-12
Registration Number : 20220916-211-J-1364(A)
Manufacturer Name : LABORATORIOS ESPINOS Y BOFIL...
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
Registrant Name : Zmax Pharmachem Co., Ltd.
Registration Date : 2022-09-16
Registration Number : 20220916-211-J-1364
Manufacturer Name : LABORATORIOS ESPINOS Y BOFIL...
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2025-02-05
Registration Number : 20250205-211-J-1756
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2025-03-14
Registration Number : 20250205-211-J-1756(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2025-08-25
Registration Number : 20250825-211-J-2002
Manufacturer Name : Olon SPA
Manufacturer Address : Via Livelli 1, Casaletto Lodigiano, 26852, Italy

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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Menivert 24mg Tablets
Dosage Form : TAB
Dosage Strength : 24mg
Packaging : 20X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 16MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 24MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Regulatory Info : Generic
Registration Country : Egypt
Brand Name :
Dosage Form : TABLET
Dosage Strength : 24MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Egypt

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Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : TABLET
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India

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Regulatory Info : Generic DCP Ongoing
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic DCP Ongoing
Registration Country : Canada

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Regulatory Info : Generic DCP Ongoing
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 16MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic DCP Ongoing
Registration Country : Canada

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Regulatory Info : Generic DCP Ongoing
Registration Country : Canada
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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Regulatory Info : Generic
Registration Country : India
Brand Name : EMETINE
Dosage Form : TABLET
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Betahistine Dihydrochloride \"2Care4\"
Dosage Form : Tablet
Dosage Strength : 16mg
Packaging :
Approval Date : 08-04-2014
Application Number : 28105210013
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Betahistin Ebb
Dosage Form : Tablet
Dosage Strength : 8mg
Packaging :
Approval Date : 07/09/2016
Application Number : 20151223000095
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Betahistina Normon
Dosage Form : Tablet
Dosage Strength : 24MG
Packaging :
Approval Date : 08-07-2019
Application Number : 84332
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : Moldova
Brand Name : Vertimed
Dosage Form : Tablet
Dosage Strength : 24mg
Packaging :
Approval Date : 30-07-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Beta Host
Dosage Form : Tablet
Dosage Strength : 8mg
Packaging :
Approval Date : 28/06/2017
Application Number : 20161027000092
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Withdrawn
Registration Country : Malta
Brand Name : Betahistine Dihydrochloride
Dosage Form : Tablet
Dosage Strength : 8MG
Packaging :
Approval Date : 2014-04-08
Application Number :
Regulatory Info : Withdrawn
Registration Country : Malta

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Menisci
Dosage Form : Tablet
Dosage Strength : 16mg
Packaging :
Approval Date : 05/02/2025
Application Number : 20230331000095
Regulatory Info : Approved
Registration Country : Sweden

Regulatory Info :
Registration Country : Italy
Brand Name : Sincrover
Dosage Form :
Dosage Strength : 20 Cpr 16 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Brand Name : Microser
Dosage Form :
Dosage Strength : Gtt Os 30 Ml 1.25 Mg/Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Betaserc
Dosage Form : Tablet
Dosage Strength : 165MG
Packaging :
Approval Date : 2020-12-02
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
16
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 Betaserc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaserc, including repackagers and relabelers. The FDA regulates Betaserc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaserc 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 Betaserc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betaserc supplier is an individual or a company that provides Betaserc active pharmaceutical ingredient (API) or Betaserc finished formulations upon request. The Betaserc suppliers may include Betaserc API manufacturers, exporters, distributors and traders.
click here to find a list of Betaserc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betaserc DMF (Drug Master File) is a document detailing the whole manufacturing process of Betaserc active pharmaceutical ingredient (API) in detail. Different forms of Betaserc DMFs exist exist since differing nations have different regulations, such as Betaserc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betaserc DMF submitted to regulatory agencies in the US is known as a USDMF. Betaserc USDMF includes data on Betaserc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betaserc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betaserc 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 Betaserc Drug Master File in Korea (Betaserc KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betaserc. The MFDS reviews the Betaserc KDMF as part of the drug registration process and uses the information provided in the Betaserc KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betaserc 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 Betaserc API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betaserc suppliers with KDMF on PharmaCompass.
A Betaserc CEP of the European Pharmacopoeia monograph is often referred to as a Betaserc Certificate of Suitability (COS). The purpose of a Betaserc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betaserc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betaserc to their clients by showing that a Betaserc CEP has been issued for it. The manufacturer submits a Betaserc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betaserc CEP holder for the record. Additionally, the data presented in the Betaserc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betaserc DMF.
A Betaserc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betaserc 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 Betaserc suppliers with CEP (COS) on PharmaCompass.
A Betaserc written confirmation (Betaserc WC) is an official document issued by a regulatory agency to a Betaserc manufacturer, verifying that the manufacturing facility of a Betaserc active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betaserc APIs or Betaserc finished pharmaceutical products to another nation, regulatory agencies frequently require a Betaserc WC (written confirmation) as part of the regulatory process.
click here to find a list of Betaserc 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 Betaserc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betaserc 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 Betaserc 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 Betaserc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betaserc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betaserc suppliers with NDC on PharmaCompass.
Betaserc 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 Betaserc 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 Betaserc GMP manufacturer or Betaserc GMP API supplier for your needs.
A Betaserc CoA (Certificate of Analysis) is a formal document that attests to Betaserc's compliance with Betaserc specifications and serves as a tool for batch-level quality control.
Betaserc CoA mostly includes findings from lab analyses of a specific batch. For each Betaserc 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.
Betaserc may be tested according to a variety of international standards, such as European Pharmacopoeia (Betaserc EP), Betaserc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betaserc USP).