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ACTIVE PHARMA INGREDIENTS

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JDMF

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VMF

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JP

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Australia

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GLOBAL SALES INFORMATION

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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
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 Weight 477.6 g/mol
Molecular Formula C26H31N5O4
XLogP32.7
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count6
Exact Mass477.23760449 g/mol
Monoisotopic Mass477.23760449 g/mol
Topological Polar Surface Area110 Ų
Heavy Atom Count35
Formal Charge0
Complexity849
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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Neuland Laboratories

India

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Inke S.A

Spain

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

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HRV Global Life Sciences

India

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

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Mankind Pharma

India

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

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Breathgreen Pharmaceuticals

U.S.A

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

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Breathgreen Pharmaceuticals

U.S.A

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

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Cipla

India

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

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Cipla

India

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Lee Pharma

India

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

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Lee Pharma

India

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

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Hovione

Portugal

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Hovione

Portugal

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Chemicea

India

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

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Chemicea

India

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Angene International

United Kingdom

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Angene International

United Kingdom

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

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USDMF

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AACR Annual meeting
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AACR Annual meeting
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41421

Submission : 2025-03-17

Status : Active

Type : II

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Cipla Ltd

India

USDMF

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Cipla Ltd

India
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41432

Submission : 2025-03-25

Status : Active

Type : II

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NDC API

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ENSIFENTRINE

NDC Package Code : 50909-1705

Start Marketing Date : 2024-06-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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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.
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Inke S.A

Spain
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Virtual BoothInke S.A: APIs manufacturing plant.

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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.
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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Ensifentrine

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Ensifentrine

About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...

Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical company in 1995. Today, we have 11,000 employees and are heading towards a turnover of INR 50000 million. Our vast network includes 50 C&F agents and 7500+ stockists. We provide a wide range of products – Antibiotic, Antifungal, NSAIDs, Gastrointestinal, Anthelmintic, Cardiovascular, Dermal, Erectile Dysfunction, and several other categories – across the nation.
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Angene International

United Kingdom
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Angene International

United Kingdom
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Ensifentrine

About the Company : Angene is pledged to providing quality chemicals for use in research and development and commercial manufacturing. Angenes offers over 100,000 products including lab reagents, inte...

Angene is pledged to providing quality chemicals for use in research and development and commercial manufacturing. Angenes offers over 100,000 products including lab reagents, intermediates, bulk commodities, agro-chemicals, natural ingredients and active pharmaceutical ingredients (APIs). In addition to the 100,000+ products, Angene offers custom synthesis of chemicals that are not commercially available.
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Chemicea

India
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Chemicea

India
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Ensifentrine

About the Company : Chemicea Pharmaceuticals is a reputable contract research organization based in Pune, India. Specializing in chemistry-driven solutions, Chemicea offers a wide range of R&D product...

Chemicea Pharmaceuticals is a reputable contract research organization based in Pune, India. Specializing in chemistry-driven solutions, Chemicea offers a wide range of R&D products and services tailored for Pharmaceutical/Biotech companies and research institutes. Certified under ISO 9001:2015, the company excels in providing pharmaceutical impurities such as Process Impurities, Degradation Impurities, API Intermediates, and Custom Synthesis. Their expertise lies in delivering high-quality solutions crucial for the development and production processes within the pharmaceutical industry.
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Ensifentrine

About the Company : Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With ...

Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With its fast and efficient synthesis, the Glixx R&D team focuses on commercializing newly discovered research chemicals and bringing them to the life sciences R&D communities. Our company goal is to help our community by lowering the cost of the essential chemicals for research needs, to better progress on to new discoveries in drug development, medical screening, and all facets of scientific innovations.
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Lee Pharma

India
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Lee Pharma

India
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Ensifentrine

About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...

Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affordable and high-quality healthcare solutions. Through advanced research, modern manufacturing, and a strong emphasis on quality, we are dedicated to producing medicines that enhance lives. Lee Pharma is a research-focused company that prioritizes the development, synthesis, and commercialization of high-quality Active Pharmaceutical Ingredients (APIs), intermediate chemicals, and finished formulations.
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ABOUT THIS PAGE

Looking for 1884461-72-6 / Ensifentrine API manufacturers, exporters & distributors?

Ensifentrine manufacturers, exporters & distributors 1

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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.

API | Excipient name

Ensifentrine

Synonyms

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

Cas Number

1884461-72-6

Unique Ingredient Identifier (UNII)

3E3D8T1GIX

About Ensifentrine

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.

Ensifentrine Manufacturers

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.

Ensifentrine Suppliers

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.

Ensifentrine USDMF

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.

Ensifentrine NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ensifentrine API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Ensifentrine CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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