Synopsis
Synopsis
0
JDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Neuland Laboratories- A dedicated 100% API provider.
Neuland Laboratories- A dedicated 100% API provider.
Certificate Number : CEP 2023-314 - Rev 00
Status : Valid
Issue Date : 2024-12-11
Type : Chemical
Substance Number : 3132
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Certificate Number : CEP 2023-286 - Rev 00
Status : Valid
Issue Date : 2025-06-03
Type : Chemical
Substance Number : 3132
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
Certificate Number : CEP 2024-344 - Rev 00
Status : Valid
Issue Date : 2025-07-25
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 2024-208 - Rev 00
Status : Valid
Issue Date : 2025-06-27
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 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
Certificate Number : CEP 2024-037 - Rev 00
Status : Valid
Issue Date : 2025-05-30
Type : Chemical
Substance Number : 3132
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Date of Issue : 2023-05-22
Valid Till : 2026-05-27
Written Confirmation Number : WC-0559
Address of the Firm : Unit-V, Gundlamachnur(V), Hathnoora (M), Sangareddy (Dist)-502296, Telangana, In...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
Date of Issue : 2025-08-05
Valid Till : 2028-06-16
Written Confirmation Number : WC-0049
Address of the Firm : Block -21, At & Post. -Dabhasa, Tal. -Padra, Dist. -Vadodara -391 440, Gujarat, ...
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No\'s. ...
Date of Issue : 2022-09-30
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...
Date of Issue : 2025-10-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0087
Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & Kl201, Village Lakhmapur, Taluka Dindo...
Date of Issue : 2025-07-07
Valid Till : 2028-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...
Date of Issue : 2025-07-07
Valid Till : 2028-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...
Date of Issue : 2025-06-30
Valid Till : 2028-07-02
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandal, Sangareddy District, T...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
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,Inapplicable
Therapeutic Area: Urology Brand Name: Myrbetriq-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 04, 2024
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
September 04, 2024
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,Inapplicable
Therapeutic Area: Urology Brand Name: Myrbetriq-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2024
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2024
Details:
Mirabegron is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Bladder, Overactive.
Lead Product(s): Mirabegron,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Il-Yang Pharm
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 26, 2023
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Il-Yang Pharm
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Mirabegron is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Bladder, Overactive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 26, 2023
Details:
DA-8010 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): DA-8010,Paroxetine Hydrochloride,Mirabegron
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 15, 2023
Lead Product(s) : DA-8010,Paroxetine Hydrochloride,Mirabegron
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
Details : DA-8010 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
August 15, 2023
Details:
Solifenacin Succinate is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Solifenacin Succinate,Mirabegron
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Hikma Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 14, 2023
Lead Product(s) : Solifenacin Succinate,Mirabegron
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Hikma Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Solifenacin Succinate is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 14, 2023
Details:
Mirabegron is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Neurogenic Detrusor Overactivity.
Lead Product(s): Mirabegron,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 18, 2022
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Mirabegron is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Neurogenic Detrusor Overactivity.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 18, 2022
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: Miscellaneous
Sponsor: Undisclosed
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 : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
March 30, 2022
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,Inapplicable
Therapeutic Area: Urology Brand Name: Myrbetriq
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 26, 2021
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
March 26, 2021
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,Inapplicable
Therapeutic Area: Urology Brand Name: Myrbetriq
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2021
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
January 06, 2021
Details:
Mirabegron is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Urinary Bladder, Overactive.
Lead Product(s): Mirabegron,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 24, 2020
Lead Product(s) : Mirabegron,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Mirabegron is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Urinary Bladder, Overactive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 24, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG
USFDA APPLICATION NUMBER - 202611
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 202611
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
47
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 Mirabegron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirabegron, including repackagers and relabelers. The FDA regulates Mirabegron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirabegron 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 Mirabegron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirabegron supplier is an individual or a company that provides Mirabegron active pharmaceutical ingredient (API) or Mirabegron finished formulations upon request. The Mirabegron suppliers may include Mirabegron API manufacturers, exporters, distributors and traders.
click here to find a list of Mirabegron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirabegron DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirabegron active pharmaceutical ingredient (API) in detail. Different forms of Mirabegron DMFs exist exist since differing nations have different regulations, such as Mirabegron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirabegron DMF submitted to regulatory agencies in the US is known as a USDMF. Mirabegron USDMF includes data on Mirabegron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirabegron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirabegron 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 Mirabegron Drug Master File in Korea (Mirabegron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirabegron. The MFDS reviews the Mirabegron KDMF as part of the drug registration process and uses the information provided in the Mirabegron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirabegron 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 Mirabegron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirabegron suppliers with KDMF on PharmaCompass.
A Mirabegron CEP of the European Pharmacopoeia monograph is often referred to as a Mirabegron Certificate of Suitability (COS). The purpose of a Mirabegron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mirabegron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mirabegron to their clients by showing that a Mirabegron CEP has been issued for it. The manufacturer submits a Mirabegron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mirabegron CEP holder for the record. Additionally, the data presented in the Mirabegron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mirabegron DMF.
A Mirabegron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mirabegron 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 Mirabegron suppliers with CEP (COS) on PharmaCompass.
A Mirabegron written confirmation (Mirabegron WC) is an official document issued by a regulatory agency to a Mirabegron manufacturer, verifying that the manufacturing facility of a Mirabegron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mirabegron APIs or Mirabegron finished pharmaceutical products to another nation, regulatory agencies frequently require a Mirabegron WC (written confirmation) as part of the regulatory process.
click here to find a list of Mirabegron 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 Mirabegron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirabegron 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 Mirabegron 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 Mirabegron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirabegron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirabegron suppliers with NDC on PharmaCompass.
Mirabegron 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 Mirabegron 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 Mirabegron GMP manufacturer or Mirabegron GMP API supplier for your needs.
A Mirabegron CoA (Certificate of Analysis) is a formal document that attests to Mirabegron's compliance with Mirabegron specifications and serves as a tool for batch-level quality control.
Mirabegron CoA mostly includes findings from lab analyses of a specific batch. For each Mirabegron 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.
Mirabegron may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirabegron EP), Mirabegron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirabegron USP).
