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1. 503070-58-4
2. Vilanterol Trifenate
3. Vilanterol (trifenatate)
4. Gw642444m
5. Unii-40aho2c6dg
6. Chebi:75040
7. Gw 642444m
8. Gw-642444m
9. Vilanterol (as Trifenatate)
10. 40aho2c6dg
11. Vilanterol Trifenatate [usan]
12. 4-[(1r)-2-[6-[2-[(2,6-dichlorophenyl)methoxy]ethoxy]hexylamino]-1-hydroxyethyl]-2-(hydroxymethyl)phenol;2,2,2-triphenylacetic Acid
13. Benzeneacetic Acid, Alpha,alpha-diphenyl-, Compd. With (alpha1r)-alpha1-[[[6-[2-[(2,6-dichlorophenyl)methoxy]ethoxy]hexyl]amino]methyl]-4-hydroxy-1,3-benzenedimethanol (1
14. Triphenylacetic Acid-4-((1r)-2-((6-(2-((2,6-dichlorobenzyl)oxy)ethoxy)hexyl)amino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol (1:1)
15. Vilanterol Triphenylacetate
16. Gw642444 (trifenatate)
17. Schembl164639
18. Chembl1084172
19. Dtxsid80659232
20. Hms3885o21
21. Vilanterol Trifenatate [mi]
22. Amy30059
23. Bcp18862
24. Ex-a4159
25. Vilanterol Trifenatate (jan/usan)
26. Vilanterol Trifenatate [jan]
27. Hy-14300a
28. S3727
29. Ccg-270458
30. Cs-1679
31. Vilanterol Trifenatate [who-dd]
32. Vilanterol Trifenatate [orange Book]
33. D09697
34. F11535
35. A899729
36. Breo Ellipta Component Vilanterol Trifenatate
37. Anoro Ellipta Component Vilanterol Trifenatate
38. Q27145087
39. Trelegy Ellipta Component Vilanterol Trifenatate
40. Vilanterol Trifenatate Component Anoro Ellipta
41. Gw 642444x;gw-642444x;gw642444x
42. Vilanterol Trifenatate Component Of Breo Ellipta
43. Vilanterol Trifenatate Component Of Trelegy Ellipta
44. 4-((1r)-2-((6-(2-((2,6-dichlorophenyl)methoxy)ethoxy)hexyl)amino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol Triphenylacetate
45. 4-[(1r)-2-[6-[2-[(2,6-dichlorophenyl)methoxy]ethoxy]hexylamino]-1-hydroxyethyl]-2-(hydroxymethyl)phenol,2,2,2-triphenylacetic Acid
46. 4-{(1r)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol Triphenylacetate
47. 6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}-n-{(2r)-2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl}hexan-1-aminium Triphenylacetate
48. Benzeneacetic Acid, Alpha,alpha-diphenyl-, Compd. With (alpha1r)-alpha1-(((6-(2-((2,6-dichlorophenyl)methoxy)ethoxy)hexyl)amino)methyl)-4-hydroxy-1,3-benzenedimethanol (1:1)
49. Triphenylacetic Acid--4-{(1r)-2-[(6-{2-[(2,6-dichlorophenyl)methoxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1/1)
50. Triphenylacetic Acid-4-((1r)-2-((6-(2-(2,6-dicholorobenzyl)oxy)ethoxy)hexyl)amino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol (1:1)
| Molecular Weight | 774.8 g/mol |
|---|---|
| Molecular Formula | C44H49Cl2NO7 |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 20 |
| Exact Mass | 773.2886083 g/mol |
| Monoisotopic Mass | 773.2886083 g/mol |
| Topological Polar Surface Area | 129 Ų |
| Heavy Atom Count | 54 |
| Formal Charge | 0 |
| Complexity | 778 |
| 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 | 2 |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-19
Pay. Date : 2023-01-09
DMF Number : 35498
Submission : 2023-03-16
Status : Active
Type : II
NDC Package Code : 64567-0027
Start Marketing Date : 2021-01-20
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36450
Submission : 2022-01-07
Status : Active
Type : II
Date of Issue : 2025-06-16
Valid Till : 2028-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
| Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC Package Code : 84644-054
Start Marketing Date : 2024-11-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25906
Submission : 2012-06-19
Status : Active
Type : II
NDC Package Code : 63379-114
Start Marketing Date : 2024-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-06-30
Registration Number : Su2480-12-ND
Manufacturer Name : Glaxo Wellcome Manufacturing Pte Ltd@[micronization process manufacturing company] Glaxo Operations UK Ltd
Manufacturer Address : 1 Pioneer Sector 1, Singapore 628413@Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39842
Submission : 2024-04-15
Status : Active
Type : II
NDC Package Code : 59057-016
Start Marketing Date : 2023-05-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37700
Submission : 2022-11-22
Status : Active
Type : II
Date of Issue : 2025-10-24
Valid Till : 2028-02-07
Written Confirmation Number : WC-0227
Address of the Firm :
Registrant Name : G-Max Pharmachem Co., Ltd.
Registration Date : 2025-10-02
Registration Number : Su660-1-ND
Manufacturer Name : Melody Healthcare Pvt. Ltd
Manufacturer Address : Plot No. J-73, MIDC, Tarapur, Boisar Dist. Palghar – 401 506, Maharashtra State, India

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36668
Submission : 2022-03-18
Status : Active
Type : II

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PharmaCompass offers a list of Vilanterol Trifenatate 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 Vilanterol Trifenatate manufacturer or Vilanterol Trifenatate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vilanterol Trifenatate manufacturer or Vilanterol Trifenatate supplier.
PharmaCompass also assists you with knowing the Vilanterol Trifenatate API Price utilized in the formulation of products. Vilanterol Trifenatate API Price is not always fixed or binding as the Vilanterol Trifenatate Price is obtained through a variety of data sources. The Vilanterol Trifenatate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BREO ELLIPTA-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BREO ELLIPTA-1, including repackagers and relabelers. The FDA regulates BREO ELLIPTA-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BREO ELLIPTA-1 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 BREO ELLIPTA-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BREO ELLIPTA-1 supplier is an individual or a company that provides BREO ELLIPTA-1 active pharmaceutical ingredient (API) or BREO ELLIPTA-1 finished formulations upon request. The BREO ELLIPTA-1 suppliers may include BREO ELLIPTA-1 API manufacturers, exporters, distributors and traders.
click here to find a list of BREO ELLIPTA-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BREO ELLIPTA-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of BREO ELLIPTA-1 active pharmaceutical ingredient (API) in detail. Different forms of BREO ELLIPTA-1 DMFs exist exist since differing nations have different regulations, such as BREO ELLIPTA-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BREO ELLIPTA-1 DMF submitted to regulatory agencies in the US is known as a USDMF. BREO ELLIPTA-1 USDMF includes data on BREO ELLIPTA-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BREO ELLIPTA-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BREO ELLIPTA-1 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 BREO ELLIPTA-1 Drug Master File in Korea (BREO ELLIPTA-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BREO ELLIPTA-1. The MFDS reviews the BREO ELLIPTA-1 KDMF as part of the drug registration process and uses the information provided in the BREO ELLIPTA-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a BREO ELLIPTA-1 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 BREO ELLIPTA-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BREO ELLIPTA-1 suppliers with KDMF on PharmaCompass.
A BREO ELLIPTA-1 written confirmation (BREO ELLIPTA-1 WC) is an official document issued by a regulatory agency to a BREO ELLIPTA-1 manufacturer, verifying that the manufacturing facility of a BREO ELLIPTA-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BREO ELLIPTA-1 APIs or BREO ELLIPTA-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a BREO ELLIPTA-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of BREO ELLIPTA-1 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 BREO ELLIPTA-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BREO ELLIPTA-1 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 BREO ELLIPTA-1 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 BREO ELLIPTA-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BREO ELLIPTA-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BREO ELLIPTA-1 suppliers with NDC on PharmaCompass.
BREO ELLIPTA-1 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 BREO ELLIPTA-1 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 BREO ELLIPTA-1 GMP manufacturer or BREO ELLIPTA-1 GMP API supplier for your needs.
A BREO ELLIPTA-1 CoA (Certificate of Analysis) is a formal document that attests to BREO ELLIPTA-1's compliance with BREO ELLIPTA-1 specifications and serves as a tool for batch-level quality control.
BREO ELLIPTA-1 CoA mostly includes findings from lab analyses of a specific batch. For each BREO ELLIPTA-1 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.
BREO ELLIPTA-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (BREO ELLIPTA-1 EP), BREO ELLIPTA-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BREO ELLIPTA-1 USP).