Synopsis
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CEP/COS
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JDMF
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EU WC
0
KDMF
0
VMF
0
EDQM
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USP
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JP
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Others
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Europe
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Canada
0
Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
US Medicaid
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1. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimidino(6,1-a)isoquinolin-4-one
2. Rpl 554
3. Rpl-554
4. Rpl554
1. Rpl-554
2. 298680-25-8
3. Rpl554
4. 1884461-72-6
5. Ensifentrine [inn]
6. Ensifentrine [usan]
7. Ls-193855
8. 3e3d8t1gix
9. Ls-193,855
10. A]isoquinolin-3(4h)-yl}ethyl)urea
11. (e)-1-(2-(2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2h-pyrimido[6,1-a]isoquinolin-3(4h)-yl)ethyl)urea
12. 2-[9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido[6,1-a]isoquinolin-3-yl]ethylurea
13. Trimethylphenyl)imino]-6,7-dihydro-2h-pyrimido[6,1-
14. N-(2-{(2e)-9,10-dimethoxy-4-oxo-2-[(2,4,6-
15. 2-(9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido(6,1-a)isoquinolin-3-yl)ethylurea
16. N-(2-((2e)-9,10-dimetoxi-4-oxo-2-((2,4,6-trimetilfenil)imino)-6,7-dihidro-2h-pirimido(6,1-a)isoquinolein-3(4h)-il)etil)urea
17. Urea, N-(2-(6,7-dihydro-9,10-dimethoxy-4-oxo-2-((2,4,6-trimethylphenyl)imino)-2h-pyrimido(6,1-a)isoquinolin-3(4h)-yl)ethyl)-
18. Unii-3e3d8t1gix
19. Vmx-554
20. Rpl-554;ensifentrinum
21. Ensifentrine (usan/inn)
22. Ensifentrine [who-dd]
23. Schembl625876
24. Chembl4594287
25. Schembl20720900
26. Gtpl11865
27. Dtxsid00183983
28. Bcp31840
29. Ex-a6633
30. Who 10726
31. Sb19810
32. D11743
33. A937318
34. Q7277486
35. Ensifentrina; Ensifentrinum;rpl-554;rpl554;rpl 554
36. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimidino(6,1-a)isoquinolin-4-one
37. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimido[6,1-a]isoquinolin-4-one
38. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimido[6,1-a]isoquinolin-4-one
39. 9,10-dimethoxy-2-(2.4.6-trimethylphenylimino)-3-(n-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2h-pyrimido[6.1-a]isoquinolin-4-one
| Molecular Weight | 477.6 g/mol |
|---|---|
| Molecular Formula | C26H31N5O4 |
| XLogP3 | 2.7 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 6 |
| Exact Mass | 477.23760449 g/mol |
| Monoisotopic Mass | 477.23760449 g/mol |
| Topological Polar Surface Area | 110 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 849 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41432
Submission : 2025-03-25
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41421
Submission : 2025-03-17
Status : Active
Type : II



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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41421
Submission : 2025-03-17
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41432
Submission : 2025-03-25
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 50909-1705
Start Marketing Date : 2024-06-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 64567-0033
Start Marketing Date : 2025-10-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
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Details:
Through the acquisition Merck will add Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of PDE3 and PDE4, to its growing cardio-pulmonary pipeline and portfolio.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Ohtuvayre
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: $10,000.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 07, 2025

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : $10,000.0 million
Deal Type : Acquisition
Merck completes acquisition of Verona Pharma
Details : Through the acquisition Merck will add Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of PDE3 and PDE4, to its growing cardio-pulmonary pipeline and portfolio.
Product Name : Ohtuvayre
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 07, 2025

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Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.
Lead Product(s): Ensifentrine,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 20, 2025

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Lead Product(s) : Ensifentrine,Glycopyrronium Bromide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Ensifentrine ± Glycopyrrolate FDC PK, PD & Safety in COPD Patients
Details : Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 20, 2025

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Details:
Through this acquisition Merck will add Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of PDE3 and PDE4, to its growing cardio-pulmonary pipeline and portfolio.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Ohtuvayre
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: $10,000.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 09, 2025

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Lead Product(s) : Ensifentrine
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : $10,000.0 million
Deal Type : Acquisition
Merck to Acquire Verona Pharma, Expanding its Portfolio to Include Ohtuvayre
Details : Through this acquisition Merck will add Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of PDE3 and PDE4, to its growing cardio-pulmonary pipeline and portfolio.
Product Name : Ohtuvayre
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 09, 2025

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Details:
Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.
Lead Product(s): Ensifentrine,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 11, 2025

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Lead Product(s) : Ensifentrine,Glycopyrronium Bromide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase IIb Study of Ensifentrine-Glycopyrrolate Fixed-dose Combo in COPD
Details : Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 11, 2025

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Details:
Verona partnered with Ritedose for the development and manufacturing partner of Ohtuvayre (ensifentrine), a new novel product for Chronic Obstructive Pulmonary Disease.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Ohtuvayre
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Verona Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 17, 2024

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Verona Pharma
Deal Size : Undisclosed
Deal Type : Partnership
Ritedose Partners with Verona Pharma To Deliver COPD Drug Ohtuvayre
Details : Verona partnered with Ritedose for the development and manufacturing partner of Ohtuvayre (ensifentrine), a new novel product for Chronic Obstructive Pulmonary Disease.
Product Name : Ohtuvayre
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 17, 2024

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Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Bronchiectasis.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 19, 2024

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Details : Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Bronchiectasis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 19, 2024

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Details:
Ohtuvayre (ensifentrine), is a first-in-class PDE3/4 inhibitor product candidate, which is being evaluated for the maintenance treatment of chronic obstructive pulmonary disease.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Ohtuvayre
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 26, 2024

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Verona Pharma Announces US FDA Approval of Ohtuvayre™ (ensifentrine)
Details : Ohtuvayre (ensifentrine), is a first-in-class PDE3/4 inhibitor product candidate, which is being evaluated for the maintenance treatment of chronic obstructive pulmonary disease.
Product Name : Ohtuvayre
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 26, 2024

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Details:
Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Midwest Chest Consultants
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 14, 2024

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Midwest Chest Consultants
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Ensifentrine Treatment on CAT Score
Details : Ensifentrine is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 14, 2024

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Details:
The proceeds will support Verona’s commercial launch of RPL554 (ensifentrine), a first-in-class product under review by the US FDA for COPD maintenance treatment.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Ohtuvayre
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Oaktree Capital
Deal Size: $650.0 million Upfront Cash: Undisclosed
Deal Type: Financing May 09, 2024

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Oaktree Capital
Deal Size : $650.0 million
Deal Type : Financing
Verona Pharma Announces $650 Million Strategic Financing with Oaktree and OMERS
Details : The proceeds will support Verona’s commercial launch of RPL554 (ensifentrine), a first-in-class product under review by the US FDA for COPD maintenance treatment.
Product Name : Ohtuvayre
Product Type : Miscellaneous
Upfront Cash : Undisclosed
May 09, 2024

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The proceeds will support Verona’s commercial launch of RPL554 (ensifentrine), a first-in-class product under review by the US FDA for COPD maintenance treatment.
Lead Product(s): Ensifentrine,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Ohtuvayre
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Oxford Finance
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing January 02, 2024

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Lead Product(s) : Ensifentrine,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Oxford Finance
Deal Size : Undisclosed
Deal Type : Financing
Verona Pharma Secures Debt Facility Of Up to $400 Million
Details : The proceeds will support Verona’s commercial launch of RPL554 (ensifentrine), a first-in-class product under review by the US FDA for COPD maintenance treatment.
Product Name : Ohtuvayre
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 02, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]6,7-Dihydro-9,10-dimethoxy-2-[(2,4,6-trimethylphen...
CAS Number : 76536-66-8
End Use API : Ensifentrine
About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...

7-Dihydro-9,10-dimethoxy-2-[(2,4,6- trimethylpheny...
CAS Number : 76536-66-8
End Use API : Ensifentrine
About The Company : Chemvisai Labs is a dynamic pharmaceutical partner established with a clear vision: to become a leading and trusted force in the industry. We address critical u...

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RLD : Yes
TE Code :
Brand Name : OHTUVAYRE
Dosage Form : SUSPENSION;INHALATION
Dosage Strength : 3MG/2.5ML
Approval Date : 2024-06-26
Application Number : 217389
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Reply
28 Nov 2024

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2035-09-15
US Patent Number : 10945950
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217389
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-15

Patent Expiration Date : 2043-02-20
US Patent Number : 12409180
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217389
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2043-02-20

Patent Expiration Date : 2044-06-25
US Patent Number : 12251384
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217389
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2044-06-25

Patent Expiration Date : 2031-08-21
US Patent Number : 9062047
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217389
Patent Use Code : U-3962
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-21

Patent Expiration Date : 2035-09-15
US Patent Number : 9956171
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217389
Patent Use Code : U-3962
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-15

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Exclusivity Code : NCE
Exclusivity Expiration Date : 2029-06-26
Application Number : 217389
Product Number : 1
Exclusivity Details :

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
52
PharmaCompass offers a list of Ensifentrine 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 Ensifentrine manufacturer or Ensifentrine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ensifentrine manufacturer or Ensifentrine supplier.
PharmaCompass also assists you with knowing the Ensifentrine API Price utilized in the formulation of products. Ensifentrine API Price is not always fixed or binding as the Ensifentrine Price is obtained through a variety of data sources. The Ensifentrine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ensifentrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ensifentrine, including repackagers and relabelers. The FDA regulates Ensifentrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ensifentrine 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 Ensifentrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ensifentrine supplier is an individual or a company that provides Ensifentrine active pharmaceutical ingredient (API) or Ensifentrine finished formulations upon request. The Ensifentrine suppliers may include Ensifentrine API manufacturers, exporters, distributors and traders.
click here to find a list of Ensifentrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ensifentrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ensifentrine active pharmaceutical ingredient (API) in detail. Different forms of Ensifentrine DMFs exist exist since differing nations have different regulations, such as Ensifentrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ensifentrine DMF submitted to regulatory agencies in the US is known as a USDMF. Ensifentrine USDMF includes data on Ensifentrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ensifentrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ensifentrine suppliers with USDMF 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 Ensifentrine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ensifentrine 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 Ensifentrine 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 Ensifentrine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ensifentrine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ensifentrine suppliers with NDC on PharmaCompass.
Ensifentrine 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 Ensifentrine 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 Ensifentrine GMP manufacturer or Ensifentrine GMP API supplier for your needs.
A Ensifentrine CoA (Certificate of Analysis) is a formal document that attests to Ensifentrine's compliance with Ensifentrine specifications and serves as a tool for batch-level quality control.
Ensifentrine CoA mostly includes findings from lab analyses of a specific batch. For each Ensifentrine 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.
Ensifentrine may be tested according to a variety of international standards, such as European Pharmacopoeia (Ensifentrine EP), Ensifentrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ensifentrine USP).