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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.
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
GDUFA
DMF Review : N/A
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DMF Number : 38770
Submission : 2023-08-31
Status : Active
Type : II
Certificate Number : CEP 2023-314 - Rev 00
Issue Date : 2024-12-11
Type : Chemical
Substance Number : 3132
Status : Valid
NDC Package Code : 58032-2040
Start Marketing Date : 2023-03-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 28392
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NDC Package Code : 55111-971
Start Marketing Date : 2015-02-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2020-08-27
Registration Number : Su574-10-ND(2)
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Chemical Technical Operations-Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India
| Available Reg Filing : ASMF, CDMF |
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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Status : Active
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Date of Issue : 2025-08-05
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NDC Package Code : 42765-047
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Marketing Category : BULK INGREDIENT
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Rev. Date : 2014-09-29
Pay. Date : 2014-07-14
DMF Number : 28392
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Type : II
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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Rev. Date : 2016-02-26
Pay. Date : 2016-01-14
DMF Number : 29925
Submission : 2015-12-31
Status : Active
Type : II
GDUFA
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Rev. Date : 2020-12-03
Pay. Date : 2018-07-09
DMF Number : 32929
Submission : 2018-09-14
Status : Active
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Certificate Number : CEP 2023-314 - Rev 00
Status : Valid
Issue Date : 2024-12-11
Type : Chemical
Substance Number : 3132
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
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Certificate Number : CEP 2024-208 - Rev 00
Status : Valid
Issue Date : 2025-06-27
Type : Chemical
Substance Number : 3132

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Certificate Number : CEP 2023-180 - Rev 02
Status : Valid
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 3132

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Certificate Number : CEP 2023-308 - Rev 00
Status : Valid
Issue Date : 2025-04-11
Type : Chemical
Substance Number : 3132

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Certificate Number : CEP 2024-031 - Rev 00
Status : Valid
Issue Date : 2025-07-09
Type : Chemical
Substance Number : 3132

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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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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] NDC Package Code : 58032-2040
Start Marketing Date : 2023-03-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC Package Code : 55111-961
Start Marketing Date : 2014-06-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 55111-971
Start Marketing Date : 2015-02-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 42765-047
Start Marketing Date : 2022-04-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-015
Start Marketing Date : 2024-01-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 66639-022
Start Marketing Date : 2016-06-08
End Marketing Date : 2026-12-31
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NDC Package Code : 65977-0133
Start Marketing Date : 2012-06-28
End Marketing Date : 2026-12-31
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NDC Package Code : 14501-0031
Start Marketing Date : 2017-03-06
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NDC Package Code : 14501-0108
Start Marketing Date : 2022-01-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 64220-191
Start Marketing Date : 2023-10-24
End Marketing Date : 2026-12-31
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Marketing Category : BULK INGREDIENT

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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company focused on the development, identification, production, and distribution of phytochemicals and botanical extracts. Its APIs a...
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A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide, including repackagers and relabelers. The FDA regulates (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide 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 (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide supplier is an individual or a company that provides (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide active pharmaceutical ingredient (API) or (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide finished formulations upon request. The (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide suppliers may include (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide API manufacturers, exporters, distributors and traders.
click here to find a list of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide DMF (Drug Master File) is a document detailing the whole manufacturing process of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide active pharmaceutical ingredient (API) in detail. Different forms of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide DMFs exist exist since differing nations have different regulations, such as (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide DMF submitted to regulatory agencies in the US is known as a USDMF. (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide USDMF includes data on (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide Drug Master File in Korea ((2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide. The MFDS reviews the (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide KDMF as part of the drug registration process and uses the information provided in the (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide KDMF to evaluate the safety and efficacy of the drug.
After submitting a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide 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 (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide API can apply through the Korea Drug Master File (KDMF).
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A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP of the European Pharmacopoeia monograph is often referred to as a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide Certificate of Suitability (COS). The purpose of a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide to their clients by showing that a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP has been issued for it. The manufacturer submits a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP (COS) as part of the market authorization procedure, and it takes on the role of a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP holder for the record. Additionally, the data presented in the (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide DMF.
A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide written confirmation ((2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide WC) is an official document issued by a regulatory agency to a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide manufacturer, verifying that the manufacturing facility of a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide APIs or (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide finished pharmaceutical products to another nation, regulatory agencies frequently require a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide WC (written confirmation) as part of the regulatory process.
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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 (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide 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 (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide 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 (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide NDC to their finished compounded human drug products, they may choose to do so.
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(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide 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 (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide GMP manufacturer or (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide GMP API supplier for your needs.
A (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CoA (Certificate of Analysis) is a formal document that attests to (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide's compliance with (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide specifications and serves as a tool for batch-level quality control.
(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide CoA mostly includes findings from lab analyses of a specific batch. For each (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide 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.
(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide may be tested according to a variety of international standards, such as European Pharmacopoeia ((2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide EP), (2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide USP).