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1. 2-(2-aminothiazol-4-yl)-4'-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)acetanilide
2. Betanis
3. Betmiga
4. Ym 178
5. Ym-178
1. 223673-61-8
2. Myrbetriq
3. Betanis
4. Betmiga
5. Ym178
6. Mirabegron (ym178)
7. Ym-178
8. Ym 178
9. 2-(2-amino-1,3-thiazol-4-yl)-n-[4-(2-{[(2r)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide
10. Mvr3jl3b2v
11. Chebi:65349
12. 2-amino-n-[4-[2-[[(2r)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]-4-thiazoleacetamide
13. (r)-2-(2-aminothiazol-4-yl)-n-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
14. 4-thiazoleacetamide, 2-amino-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)-
15. Myrbetriq (tn)
16. 2-(2-amino-1,3-thiazol-4-yl)-n-[4-[2-[[(2r)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]acetamide
17. 2-(2-azanyl-1,3-thiazol-4-yl)-n-[4-[2-[[(2r)-2-oxidanyl-2-phenyl-ethyl]amino]ethyl]phenyl]ethanamide
18. Mirabegron [usan:inn]
19. Unii-mvr3jl3b2v
20. 2-(2-amino-1,3-thiazol-4-yl)-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
21. Mirabegron [mi]
22. Mirabegron [inn]
23. Mirabegron [jan]
24. Mirabegron (usan/jan)
25. Mirabegron [usan]
26. Mirabegron [vandf]
27. Mirabegron [mart.]
28. Mirabegron [who-dd]
29. N-(4-(2-(2-hydroxy-2-phenylethylamino)ethyl)phenyl)-2-(2-aminothiazol-4-yl)acetamide
30. Schembl904788
31. Gtpl7445
32. Chembl2095212
33. Mirabegron [orange Book]
34. Amy1800
35. Dtxsid101021648
36. Hms3714i09
37. Hms3885m16
38. 2-(2-amino-1,3-thiazol-4-yl)-n-(4-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}phenyl)acetamide
39. Ex-a1050
40. Zinc1996784
41. Mfcd11100356
42. S4009
43. Akos016340341
44. Ccg-268611
45. Cs-0915
46. Db08893
47. Ks-1398
48. 2-(2-aminothiazol-4-yl)-4'-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)acetanilide
49. Ncgc00386239-01
50. Hy-14773
51. Sw220301-1
52. D09535
53. Ab01565808_02
54. A816162
55. Ar-270/43507997
56. Q3702534
57. (r)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide
58. (r)-2-(2-aminothiazol-4-yl)-4-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}acetanilide
59. (r)-2-(2-aminothiazol-4-yl)-n-(4-(2-(2-hydroxy-2-phenylethylamino)ethyl)phenyl)acetamide
60. 2-(2-aminothiazol-4-yl)-n-(4-(2-(((2r)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
61. H6u
62. Ym 178;2-(2-aminothiazol-4-yl)-n-[4-[2-[[(2r)-2-hydroxy-2-phenyl-ethyl]amino]ethyl]phenyl]acetamide
| Molecular Weight | 396.5 g/mol |
|---|---|
| Molecular Formula | C21H24N4O2S |
| XLogP3 | 2.1 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 9 |
| Exact Mass | 396.16199719 g/mol |
| Monoisotopic Mass | 396.16199719 g/mol |
| Topological Polar Surface Area | 129 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 467 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Myrbetriq |
| PubMed Health | Mirabegron (Oral route) |
| Drug Label | Mirabegron is a beta-3 adrenergic agonist. The chemical name is 2-(2-aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural fo... |
| Active Ingredient | Mirabegron |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 25mg; 50mg |
| Market Status | Prescription |
| Company | Apgdi |
| 2 of 2 | |
|---|---|
| Drug Name | Myrbetriq |
| PubMed Health | Mirabegron (Oral route) |
| Drug Label | Mirabegron is a beta-3 adrenergic agonist. The chemical name is 2-(2-aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural fo... |
| Active Ingredient | Mirabegron |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 25mg; 50mg |
| Market Status | Prescription |
| Company | Apgdi |
Mirabegron is indicated for the treatment of overactive bladder (OAB) - with symptoms of urge urinary incontinence, urgency, and urinary frequency - either alone or in combination with [solifenacin]. It is also indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35kg or more.
Symptomatic treatment of urgency.
Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.
Treatment of idiopathic overactive bladder
Treatment of neurogenic detrusor overactivity
Mirabegron exerts its pharmacologic effects by forcing bladder smooth muscle to relax, thereby expanding its capacity and relieving urgency. Mirabegron does not appear to adversely affect the mean maximum flow rate or mean detrusor pressure at maximum flow rate in patients with lower urinary tract symptoms and bladder outlet obstruction (BOO), but should be used with in patients with BOO due to reports of significant urinary retention. Furthermore, mirabegron increases both blood pressure and heart rate in a dose-dependent manner and should therefore be used with caution in patients with severely uncontrolled hypertension or others for whom these increases may prove dangerous.
Adrenergic beta-3 Receptor Agonists
Compounds that bind to and activate ADRENERGIC BETA-3 RECEPTORS. (See all compounds classified as Adrenergic beta-3 Receptor Agonists.)
Urological Agents
Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)
G04BD12
G - Genito urinary system and sex hormones
G04 - Urologicals
G04B - Urologicals
G04BD - Drugs for urinary frequency and incontinence
G04BD12 - Mirabegron
Absorption
The absolute bioavailability of orally administered mirabegron ranges from 29% at a dose of 25 mg to 35% at a dose of 50 mg. The Tmax for the extended-release tablet and suspension formulations are approximately 3.5 hours, while the Tmax for the granule formulation is 4-5 hours. Both Cmax and AUC increase more than dose proportionally - an increase in dose from 50mg to 100mg results in a 2.9- and 2.6-fold increase in Cmax and AUC, respectively, whereas an increase from 50mg to 200mg results in a 8.4- and 6.5-fold increase in Cmax and AUC, respectively. Steady-state concentrations of mirabegron are achieved after approximately 7 days of once-daily administration.
Route of Elimination
Of a 160mg radiolabeled dose administered to healthy volunteers, approximately 55% of the radioactivity was recovered in the urine and 34% in the feces. Approximately 25% of unchanged mirabegron was recovered in the urine while 0% was recovered in the feces. Renal elimination is achieved primarily via active tubular secretion with some contribution by glomerular filtration.
Volume of Distribution
Following intravenous administration, mirabegron has an apparent steady-state volume of distribution (Vd) of 1670 L indicating extensive distribution.
Clearance
Total plasma clearance following intravenous administration is approximately 57 L/h, with renal clearance accounting for roughly 25% at approximately 13 L/h.
Mirabegron is extensively metabolized via a number of mechanisms, although unchanged parent drug is still the major circulating component following oral administration. Presumed metabolic pathways and their resultant metabolites include amide hydrolysis (M5, M16, M17), glucuronidation (mirabegron O-glucuronide, N-glucuronide, N-carbamoylglucuronide, M12), and secondary amine oxidation or dealkylation (M8, M9, M15), amongst others. The enzymes responsible for the oxidative metabolism of mirabegron are thought to be CYP3A4 and CYP2D6, while the UDP-glucuronosyltransferases responsible for conjugation reactions have been identified as UGT2B7, UGT1A3, and UGT1A8. Other enzymes that may be involved in the metabolism of mirabegron include butylcholinesterase and possibly alcohol dehydrogenase.
The mean terminal elimination half-life of mirabegron in adults being treated for overactive bladder is approximately 50 hours. In pediatric patients receiving the granule formulation for the treatment of neurogenic detrusor overactivity, the mean terminal elimination half-life is approximately 26-31 hours.
Mirabegron is a potent and selective agonist of beta-3 adrenergic receptors. The activation of beta-3 receptors relaxes detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle, which increases the bladder's storage capacity thereby alleviating feelings of urgency and frequency.
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Certificate Number : CEP 2023-314 - Rev 00
Status : Valid
Issue Date : 2024-12-11
Type : Chemical
Substance Number : 3132
Certificate Number : CEP 2024-056 - Rev 00
Status : Valid
Issue Date : 2025-03-19
Type : Chemical
Substance Number : 3132
Certificate Number : CEP 2023-180 - Rev 02
Status : Valid
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 3132
Certificate Number : CEP 2024-087 - Rev 00
Status : Valid
Issue Date : 2025-03-28
Type : Chemical
Substance Number : 3132
Certificate Number : CEP 2023-308 - Rev 00
Status : Valid
Issue Date : 2025-04-11
Type : Chemical
Substance Number : 3132
Mirabegron, Micronised And Non-micronised
Certificate Number : CEP 2023-249 - Rev 00
Status : Valid
Issue Date : 2025-04-10
Type : Chemical
Substance Number : 3132
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Mirabegron Amorphous IH/Mirabegron IH
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
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Drugs in Development
Details:
Myrbetriq-Generic (mirabegron) is an FDA-approved beta-3 adrenergic receptor inhibitor for treating overactive bladder with urge incontinence and urinary urgency.
Lead Product(s): Mirabegron
Therapeutic Area: Urology Brand Name: Myrbetriq-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2024
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Launches Mirabegron Extended-release Tablets in the US
Details : Myrbetriq-Generic (mirabegron) is an FDA-approved beta-3 adrenergic receptor inhibitor for treating overactive bladder with urge incontinence and urinary urgency.
Product Name : Myrbetriq-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2024
Details:
Mirabegron is a beta-3 adrenergic receptor inhibitor approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
Lead Product(s): Mirabegron
Therapeutic Area: Urology Brand Name: Myrbetriq-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 09, 2024
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Launches Mirabegron Extended-Release Tablets in the US
Details : Mirabegron is a beta-3 adrenergic receptor inhibitor approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
Product Name : Myrbetriq-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 09, 2024
Details:
Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.
Lead Product(s): Solifenacin Succinate,Mirabegron
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 30, 2022
Lead Product(s) : Solifenacin Succinate,Mirabegron
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules
Details : Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 30, 2022
Details:
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.
Lead Product(s): Mirabegron
Therapeutic Area: Urology Brand Name: Myrbetriq
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 01, 2021
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.
Product Name : Myrbetriq
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 01, 2021
Details:
The U.S. Food and Drug Administration (FDA) approved Myrbetriq for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules for the treatment of NDO in pediatric patients aged three years and older.
Lead Product(s): Mirabegron
Therapeutic Area: Urology Brand Name: Myrbetriq
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 26, 2021
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The U.S. Food and Drug Administration (FDA) approved Myrbetriq for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules for the treatment of NDO in pediatric patients aged three years and...
Product Name : Myrbetriq
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 26, 2021
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RLD : No
TE Code : AB
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 25MG
Approval Date : 2024-02-12
Application Number : 215948
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 50MG
Approval Date : 2024-02-12
Application Number : 215948
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Brand Name : MYRBETRIQ GRANULES
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;ORAL
Dosage Strength : 8MG/ML
Approval Date : 2021-03-25
Application Number : 213801
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 50MG
Approval Date : 2025-01-02
Application Number : 209434
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 25MG
Approval Date : 2022-09-28
Application Number : 209485
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 50MG
Approval Date : 2022-09-28
Application Number : 209485
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE
Dosage Strength : 50MG
Approval Date :
Application Number : 217989
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE
Dosage Strength : 25MG
Approval Date :
Application Number : 217989
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 25MG
Approval Date : 2019-12-27
Application Number : 209446
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : MIRABEGRON
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 25MG
Approval Date : 2022-09-29
Application Number : 209488
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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Registration Country : Sweden
Brand Name : Betmiga
Dosage Form : PROLONGED-RELEASE TABLET
Dosage Strength : 25 MG
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Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depottablett
Dosage Strength : 25 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depottablett
Dosage Strength : 25 mg
Packaging : Blister
Approval Date :
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Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depottablett
Dosage Strength : 50 mg
Packaging : Blister
Approval Date :
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Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depottablett
Dosage Strength : 50 mg
Packaging : Blister
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Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depot tablet
Dosage Strength : 50 mg
Packaging : Blisterpakning 30item
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Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depot tablet
Dosage Strength : 50 mg
Packaging : Blisterpakning 90item
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Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depot tablet
Dosage Strength : 25 mg
Packaging : Blisterpakning 30item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Betmiga
Dosage Form : Depot tablet
Dosage Strength : 25 mg
Packaging : Blisterpakning 90item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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Registration Country : Switzerland
Brand Name : Betmiga
Dosage Form : Ret Tablet
Dosage Strength : 25mg
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Registration Country : Switzerland
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG
USFDA APPLICATION NUMBER - 202611
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 202611
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RX/OTC/DISCN :
Dosage Form : Depot tablet
Dosage Strength : 50 mg
Price Per Pack (Euro) : 26.38
Published in :
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RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depot tablet
Dosage Strength : 50 mg
Price Per Pack (Euro) : 76.57
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RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depot tablet
Dosage Strength : 25 mg
Price Per Pack (Euro) : 26.38
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depot tablet
Dosage Strength : 25 mg
Price Per Pack (Euro) : 76.57
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depottablett
Dosage Strength : 25 mg
Price Per Pack (Euro) : 40.909
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depottablett
Dosage Strength : 25 mg
Price Per Pack (Euro) : 113.25
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depottablett
Dosage Strength : 50 mg
Price Per Pack (Euro) : 40.909
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depottablett
Dosage Strength : 50 mg
Price Per Pack (Euro) : 113.25
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Depottablett
Dosage Strength : 50 mg
Price Per Pack (Euro) : 113.25
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RX/OTC/DISCN :
RX/OTC/DISCN : Class B
Dosage Form : Ret Tablet
Dosage Strength : 25mg
Price Per Pack (Euro) : 36.74
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
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PharmaCompass offers a list of Mirabegron 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 Mirabegron manufacturer or Mirabegron supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirabegron manufacturer or Mirabegron supplier.
PharmaCompass also assists you with knowing the Mirabegron API Price utilized in the formulation of products. Mirabegron API Price is not always fixed or binding as the Mirabegron Price is obtained through a variety of data sources. The Mirabegron Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Betanis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betanis, including repackagers and relabelers. The FDA regulates Betanis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betanis 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 Betanis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betanis supplier is an individual or a company that provides Betanis active pharmaceutical ingredient (API) or Betanis finished formulations upon request. The Betanis suppliers may include Betanis API manufacturers, exporters, distributors and traders.
click here to find a list of Betanis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betanis DMF (Drug Master File) is a document detailing the whole manufacturing process of Betanis active pharmaceutical ingredient (API) in detail. Different forms of Betanis DMFs exist exist since differing nations have different regulations, such as Betanis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betanis DMF submitted to regulatory agencies in the US is known as a USDMF. Betanis USDMF includes data on Betanis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betanis USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betanis 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 Betanis Drug Master File in Korea (Betanis KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betanis. The MFDS reviews the Betanis KDMF as part of the drug registration process and uses the information provided in the Betanis KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betanis 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 Betanis API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betanis suppliers with KDMF on PharmaCompass.
A Betanis CEP of the European Pharmacopoeia monograph is often referred to as a Betanis Certificate of Suitability (COS). The purpose of a Betanis CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betanis EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betanis to their clients by showing that a Betanis CEP has been issued for it. The manufacturer submits a Betanis CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betanis CEP holder for the record. Additionally, the data presented in the Betanis CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betanis DMF.
A Betanis CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betanis 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 Betanis suppliers with CEP (COS) on PharmaCompass.
A Betanis written confirmation (Betanis WC) is an official document issued by a regulatory agency to a Betanis manufacturer, verifying that the manufacturing facility of a Betanis active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betanis APIs or Betanis finished pharmaceutical products to another nation, regulatory agencies frequently require a Betanis WC (written confirmation) as part of the regulatory process.
click here to find a list of Betanis 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 Betanis as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betanis 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 Betanis 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 Betanis and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betanis NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betanis suppliers with NDC on PharmaCompass.
Betanis 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 Betanis 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 Betanis GMP manufacturer or Betanis GMP API supplier for your needs.
A Betanis CoA (Certificate of Analysis) is a formal document that attests to Betanis's compliance with Betanis specifications and serves as a tool for batch-level quality control.
Betanis CoA mostly includes findings from lab analyses of a specific batch. For each Betanis 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.
Betanis may be tested according to a variety of international standards, such as European Pharmacopoeia (Betanis EP), Betanis JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betanis USP).
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