Synopsis
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DRUG PRODUCT COMPOSITIONS0
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1. 67555, R
2. Alpha,alpha'-(iminobis(methylene))bis(6-fluoro-3,4-dihydro)-2h-1-benzopyran-2-methanol
3. Bystolic
4. Hydrochloride, Nebivolol
5. Lobivon
6. Nebilet
7. Nebivolol
8. R 67555
9. R-67555
10. R67555
11. Silostar
1. 169293-50-9
2. Nebivolol Hcl
3. 2,2'-azanediylbis(1-(6-fluorochroman-2-yl)ethanol) Hydrochloride
4. 152520-56-4
5. Rac Nebivolol Hydrochloride
6. R 065824 Hydrochloride
7. Nebilox
8. Rac-nebivolol Hcl
9. R-067555
10. Schembl514784
11. N-phenyliminodiaceticacid
12. Chembl1201731
13. Akos016006035
14. Ac-4233
15. Ac-5636
16. Ccg-214847
17. Ro67555
18. As-12100
19. Cs-0362720
20. Ft-0652243
21. Ft-0655833
22. 520n564
23. W-60374
24. J-010524
25. 1-(6-fluoro-3,4-dihydro-2h-chromen-2-yl)-2-[[2-(6-fluoro-3,4-dihydro-2h-chromen-2-yl)-2-hydroxyethyl]amino]ethanol;hydrochloride
26. 2h-1-benzopyran-2-methanol,a,a'-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-,hydrochloride(1:1)
27. Alpha,alpha'[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2h-1-benzopyran-2-methanol]hydrochloride
| Molecular Weight | 441.9 g/mol |
|---|---|
| Molecular Formula | C22H26ClF2NO4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 6 |
| Exact Mass | 441.1518423 g/mol |
| Monoisotopic Mass | 441.1518423 g/mol |
| Topological Polar Surface Area | 71 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 483 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 4 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Adrenergic beta-1 Receptor Agonists
Compounds that bind to and activate ADRENERGIC BETA-1 RECEPTORS. (See all compounds classified as Adrenergic beta-1 Receptor Agonists.)
Antihypertensive Agents
Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)
Vasodilator Agents
Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)
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Average Price (USD/KGS) |
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DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG
USFDA APPLICATION NUMBER - 206302
DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 21742
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE
USFDA APPLICATION NUMBER - 21742
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USFDA APPLICATION NUMBER - 21742
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 21742
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ABOUT THIS PAGE
A Nebivolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nebivolol, including repackagers and relabelers. The FDA regulates Nebivolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nebivolol 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 Nebivolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nebivolol supplier is an individual or a company that provides Nebivolol active pharmaceutical ingredient (API) or Nebivolol finished formulations upon request. The Nebivolol suppliers may include Nebivolol API manufacturers, exporters, distributors and traders.
click here to find a list of Nebivolol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nebivolol DMF (Drug Master File) is a document detailing the whole manufacturing process of Nebivolol active pharmaceutical ingredient (API) in detail. Different forms of Nebivolol DMFs exist exist since differing nations have different regulations, such as Nebivolol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nebivolol DMF submitted to regulatory agencies in the US is known as a USDMF. Nebivolol USDMF includes data on Nebivolol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nebivolol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nebivolol 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 Nebivolol Drug Master File in Korea (Nebivolol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nebivolol. The MFDS reviews the Nebivolol KDMF as part of the drug registration process and uses the information provided in the Nebivolol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nebivolol 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 Nebivolol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nebivolol suppliers with KDMF on PharmaCompass.
A Nebivolol CEP of the European Pharmacopoeia monograph is often referred to as a Nebivolol Certificate of Suitability (COS). The purpose of a Nebivolol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nebivolol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nebivolol to their clients by showing that a Nebivolol CEP has been issued for it. The manufacturer submits a Nebivolol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nebivolol CEP holder for the record. Additionally, the data presented in the Nebivolol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nebivolol DMF.
A Nebivolol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nebivolol 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 Nebivolol suppliers with CEP (COS) on PharmaCompass.
A Nebivolol written confirmation (Nebivolol WC) is an official document issued by a regulatory agency to a Nebivolol manufacturer, verifying that the manufacturing facility of a Nebivolol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nebivolol APIs or Nebivolol finished pharmaceutical products to another nation, regulatory agencies frequently require a Nebivolol WC (written confirmation) as part of the regulatory process.
click here to find a list of Nebivolol 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 Nebivolol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nebivolol 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 Nebivolol 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 Nebivolol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nebivolol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nebivolol suppliers with NDC on PharmaCompass.
Nebivolol 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 Nebivolol 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 Nebivolol GMP manufacturer or Nebivolol GMP API supplier for your needs.
A Nebivolol CoA (Certificate of Analysis) is a formal document that attests to Nebivolol's compliance with Nebivolol specifications and serves as a tool for batch-level quality control.
Nebivolol CoA mostly includes findings from lab analyses of a specific batch. For each Nebivolol 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.
Nebivolol may be tested according to a variety of international standards, such as European Pharmacopoeia (Nebivolol EP), Nebivolol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nebivolol USP).
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