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ACTIVE PHARMA INGREDIENTS

7 API Suppliers, 1 NDC API, 7 Listed Suppliers

7 API Suppliers
1 NDC API
7 Listed Suppliers

DEVELOPMENTS

39 Drugs in Development

39 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 1 FDA Orange Book, 1 Listed Dossiers

2 FDF Dossiers
1 FDA Orange Book
1 Listed Dossiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 2 STOCK RECAP #PipelineProspector, 42 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
2 STOCK RECAP #PipelineProspector
42 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

3 US Patents, 1 US Exclusivities

patents
3 US Patents
1 US Exclusivities

Neuland Lab Ensifentrine

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Rpl-554, 298680-25-8, Rpl554, 1884461-72-6, Ensifentrine [inn], Ensifentrine [usan]

Molecular Formula

C₂₆H₃₁N₅O₄

Molecular Weight

477.6 g/mol

InChI Key

CSOBIBXVIYAXFM-UHFFFAOYSA-N

FDA UNII

3E3D8T1GIX

Ensifentrine is an inhaled inhibitor of the phosphodiesterase (PDE) types 3 (PDE3) and 4 (PDE4), with potential anti-inflammatory and bronchodilator activities. Upon administration, ensifentrine targets, binds to and inhibits PDE3 and PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. This may lead to bronchial smooth muscle relaxation and modulate inflammatory responses. PDE3 and PDE4, members of the PDE superfamily, hydrolyze cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates. PDE3 is the most expressed PDE isoenzyme in bronchial smooth muscle. PDE4 is expressed in immune cells including T-cells, monocytes, macrophages, neutrophils, dendritic cells and eosinophils. It plays an important role in inflammation, especially in inflammatory airway diseases.

1 2D Structure

Ensifentrine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[9,10-dimethoxy-4-oxo-2-(2,4,6-trimethylphenyl)imino-6,7-dihydropyrimido[6,1-a]isoquinolin-3-yl]ethylurea

2.1.2 InChI

InChI=1S/C26H31N5O4/c1-15-10-16(2)24(17(3)11-15)29-23-14-20-19-13-22(35-5)21(34-4)12-18(19)6-8-30(20)26(33)31(23)9-7-28-25(27)32/h10-14H,6-9H2,1-5H3,(H3,27,28,32)

2.1.3 InChI Key

CSOBIBXVIYAXFM-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CC(=C(C(=C1)C)N=C2C=C3C4=CC(=C(C=C4CCN3C(=O)N2CCNC(=O)N)OC)OC)C

2.2 Other Identifiers

2.2.1 UNII

3E3D8T1GIX

2.3 Synonyms

2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₁N₅O₄
Molecular Weight	477.6 g/mol
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 Å²
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

API SUPPLIERS

01

Neuland Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Neuland Laboratories- A dedicated 100% API provider.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Inke S.A

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Exhibiting

Inke S.A: APIs manufacturing plant.

Contact Supplier

Spain

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Product Web Link

03

Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Contact Supplier

France

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

Chongqing Sintaho Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

Contact Supplier

China

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

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05

Glixx Laboratories

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

06

Angene International

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

07

Chemicea

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

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NDC API

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Listed Suppliers

01

Neuland Laboratories

India

AES 2024

Not Confirmed

Neuland Laboratories- A dedicated 100% API provider.

Contact Supplier

India

Virtual Booth

Digital Content

Ensifentrine

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...

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 pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.

02

Inke S.A

Spain

DDL Conference

Exhibiting

Inke S.A: APIs manufacturing plant.

Contact Supplier

Spain

Virtual Booth

Digital Content

Ensifentrine

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.

Product Web Link

03

Seqens

France

AES 2024

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Contact Supplier

France

Virtual Booth

Digital Content

Ensifentrine

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.

04

Chongqing Sintaho Pharmaceutical

China

AES 2024

Not Confirmed

Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Ensifentrine

About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...

Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosynthetic APIs (application contains oncology, nervous system, and metabolic diseases and etc.,) with a product portfolio ranging from small molecule APIs, ADC compounds (linkers and payloads) to polypeptides, also provides CDMO services of cytotoxic and OEB4/5 grade APIs.

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