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Chemistry

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Also known as: Ciloprost, Ventavis, Endoprost, Ilomedin, 78919-13-8, Iloprostum
Molecular Formula
C22H32O4
Molecular Weight
360.5  g/mol
InChI Key
HIFJCPQKFCZDDL-ACWOEMLNSA-N
FDA UNII
JED5K35YGL

Iloprost
An eicosanoid, derived from the cyclooxygenase pathway of arachidonic acid metabolism. It is a stable and synthetic analog of EPOPROSTENOL, but with a longer half-life than the parent compound. Its actions are similar to prostacyclin. Iloprost produces vasodilation and inhibits platelet aggregation.
Iloprost is a Prostacycline.
1 2D Structure

Iloprost

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(5E)-5-[(3aS,4R,5R,6aS)-5-hydroxy-4-[(E,3S)-3-hydroxy-4-methyloct-1-en-6-ynyl]-3,3a,4,5,6,6a-hexahydro-1H-pentalen-2-ylidene]pentanoic acid
2.1.2 InChI
InChI=1S/C22H32O4/c1-3-4-7-15(2)20(23)11-10-18-19-13-16(8-5-6-9-22(25)26)12-17(19)14-21(18)24/h8,10-11,15,17-21,23-24H,5-7,9,12-14H2,1-2H3,(H,25,26)/b11-10+,16-8+/t15?,17-,18+,19-,20+,21+/m0/s1
2.1.3 InChI Key
HIFJCPQKFCZDDL-ACWOEMLNSA-N
2.1.4 Canonical SMILES
CC#CCC(C)C(C=CC1C(CC2C1CC(=CCCCC(=O)O)C2)O)O
2.1.5 Isomeric SMILES
CC#CCC(C)[C@@H](/C=C/[C@H]1[C@@H](C[C@H]2[C@@H]1C/C(=C/CCCC(=O)O)/C2)O)O
2.2 Other Identifiers
2.2.1 UNII
JED5K35YGL
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ciloprost

2. Ventavis

3. Zk 36374

4. Zk-36374

5. Zk36374

2.3.2 Depositor-Supplied Synonyms

1. Ciloprost

2. Ventavis

3. Endoprost

4. Ilomedin

5. 78919-13-8

6. Iloprostum

7. Zk-36374

8. Jed5k35ygl

9. Zk 36374

10. Chembl494

11. Chebi:63916

12. Zk 00036374

13. (5e)-5-[(3as,4r,5r,6as)-5-hydroxy-4-[(e,3s)-3-hydroxy-4-methyloct-1-en-6-ynyl]-3,3a,4,5,6,6a-hexahydro-1h-pentalen-2-ylidene]pentanoic Acid

14. [3h]-iloprost

15. Ventavis (tn)

16. Zk-00036374

17. 73873-87-7

18. (16r,s)-methyl-18,18,19,19-tetradehydro-6a-carbaprostaglandin I2

19. 15(r)-iloprost

20. (5e)-5-[(3as,4r,5r,6as)-5-hydroxy-4-[(1e,3s)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl]hexahydropentalen-2(1h)-ylidene]pentanoic Acid

21. Iloprostum [latin]

22. Sr-05000001498

23. Unii-jed5k35ygl

24. Iloprost [usan:inn:ban]

25. Ilomedine

26. Bay Q6256

27. Iloprost [usan]

28. Iloprost (usan/inn)

29. Iloprost [inn]

30. Iloprost [jan]

31. Iloprost [mi]

32. Iloprost [vandf]

33. Iloprost [mart.]

34. Iloprost [who-dd]

35. Iloprost [ema Epar]

36. Iloprost [orange Book]

37. Schembl6083382

38. Iloprost, >=98% (hplc)

39. Bay-q-6256

40. Dtxsid2041046

41. Bdbm23954

42. Hms2090a19

43. 85026-51-3

44. Ex-a6213

45. Hy-a0096

46. Sh-401

47. (16r,s)-methyl-18,18,19,19-tetradehydro-6a-carbaprostaglandin I(sub 2)

48. Akos024456922

49. Cs-5586

50. Db01088

51. (e)-5-(3as,4r,5r,6as)-5-hydroxy-4((e)-(3s,4rs)-3-hydroxy-4-methyl-1-octen-6-inyl)perhydropentalen-2-yliden)valeriansaeure

52. Pentanoic Acid, 5-(hexahydro-5-hydroxy-4-(3-hydroxy-4-methyl-1-octen-6-ynyl)-2(1h)-pentalenylidene)-

53. D02721

54. E-1030

55. Aceticacid2-tert-butyl-4-methylphenylester

56. J-502615

57. Sr-05000001498-1

58. Sr-05000001498-2

59. Brd-a45664787-001-01-4

60. Brd-a45664787-001-02-2

61. Q20817139

62. (1s,2r,3r,5s)-7-[(e)-4-carboxybutylidene]-2-[(3s,1e)-3-hydroxy-4-methyl-6-octyne-1-enyl]-3-hydroxybicyclo[3.3.0]octane

63. (5e)-(3as,4r,5r,6as)-5-hydroxy-4-((1e)-(3s,4rs)-3-hydroxy-4-methyloct-1-en-6-ynyl)-hexahydropentalen-2(1h)-ylidene)pentanoic Acid

64. (5e)-5-[(3as,4r,5r,6as)-hexahydro-5-hydroxy-4-[(1e,3s)-3-hydroxy-4-methyl-1-octen-6-ynyl]-2(1h)-pentalenylidene]pentanoic Acid

65. (e)-(3as,4r,5r,6as)-hexahydro-5-hydroxy-4-((e)-(3s,4rs)-3-hydroxy-4-methyl-1-octen-6-ynyl)-delta(sup 2(1h),delta)-pentalenevaleric Acid

66. (z)-5-((3as,4r,5r,6as)-5-hydroxy-4-((3s,e)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl)hexahydropentalen-2(1h)-ylidene)pentanoic Acid

67. 5-[(2e,3as,4r,5r,6as)-5-hydroxy-4-[(1e,3s)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl]-octahydropentalen-2-ylidene]pentanoic Acid

68. Pentanoic Acid, 5-((3as,4r,5r,6as)-hexahydro-5-hydroxy-4-((1e,3s)-3-hydroxy-4-methyl-1-octen-6-ynyl)-2(1h)-pentalenylidene)-, (5e)-

2.4 Create Date
2005-12-16
3 Chemical and Physical Properties
Molecular Weight 360.5 g/mol
Molecular Formula C22H32O4
XLogP32.8
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count8
Exact Mass360.23005950 g/mol
Monoisotopic Mass360.23005950 g/mol
Topological Polar Surface Area77.8 Ų
Heavy Atom Count26
Formal Charge0
Complexity606
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Used for the treatment of pulmonary arterial hypertension.


FDA Label


Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Iloprost is a synthetic analogue of prostacyclin PGI2 that dilates systemic and pulmonary arterial vascular beds. It was shown to affect platelet aggregation, but whether this effect contributes to its vasodilatory action has not been elucidated. There are two diastereoisomers of iloprost and the 4S isomer is reported to exhibit a higher potency in dilating blood vessels compared to the 4R isomer.


5.2 MeSH Pharmacological Classification

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


Platelet Aggregation Inhibitors

Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. (See all compounds classified as Platelet Aggregation Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ILOPROST
5.3.2 FDA UNII
JED5K35YGL
5.3.3 Pharmacological Classes
Prostaglandins I [CS]; Prostacycline [EPC]
5.4 ATC Code

B01AC11


B01AC11

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


B - Blood and blood forming organs

B01 - Antithrombotic agents

B01A - Antithrombotic agents

B01AC - Platelet aggregation inhibitors excl. heparin

B01AC11 - Iloprost


5.5 Absorption, Distribution and Excretion

Absorption

Rapidly absorbed with bioavailability of 63%


Volume of Distribution

0.7 to 0.8 L/kg


Clearance

20 mL/min/kg [Normal subjects]


5.6 Metabolism/Metabolites

Primarily hepatic. Iloprost is metabolized principally via beta-oxidation of the carboxyl side chain.


5.7 Biological Half-Life

20-30 minutes


5.8 Mechanism of Action

Iloprost is a second generation structural analog of prostacyclin (PGI) with about ten-fold greater potency than the first generation stable analogs, such as carbaprostacyclin. Iloprost binds with equal affinity to human prostacyclin (Prostanoid IP) and prostaglandin EP1 receptors. Iloprost constricts the ilium and fundus circular smooth muscle as strongly as prostaglandin E2 (PGE2) itself. Iloprost inhibits the ADP, thrombin, and collagen-induced aggregation of human platelets. In whole animals, iloprost acts as a vasodilator, hypotensive, antidiuretic, and prolongs bleeding time. All of these properties help to antagonize the pathological changes that take place in the small pulmonary arteries of patients with pulmonary hypertension.


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ILOPROST

NDC Package Code : 82231-109

Start Marketing Date : 2018-09-28

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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ILOPROST

NDC Package Code : 54893-0017

Start Marketing Date : 2012-05-05

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Virtual BoothChirogate is a professional Prostaglandin manufacturer.

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Iloprost

About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. With a focus on quality and compliance, Chirogate has built a reput...

Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. With a focus on quality and compliance, Chirogate has built a reputation as a professional API supplier. Through innovative proprietary processes and advanced technology platforms, Chirogate offers competitively priced prostaglandin products to customers in both regulated and unregulated markets worldwide. Its activities adhere to stringent cGMP regulations and international drug manufacturing codes, guaranteeing the safety and quality of its products. Chirogate has been successfully inspected by regulatory agencies like the USFDA.
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EUROAPI

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About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...

EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
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About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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LGM Pharma

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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NEWCHEM SPA

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About the Company : NEWCHEM is an independent Italian manufacturer of Active Pharmaceutical Ingredients (APIs) - Steroids, Progestogens, Prostafglandins. NEWCHEM is active on the worldwide Pharmaceut...

NEWCHEM is an independent Italian manufacturer of Active Pharmaceutical Ingredients (APIs) - Steroids, Progestogens, Prostafglandins. NEWCHEM is active on the worldwide Pharmaceutical Manufacturing market. Quality and reliability are guaranteed by the proven experience of EFFECHEM. NEWCHEM recruits only highly specialized personnel to work in compliance with the strictest regulations.The company is constantly updating its procedures to meet the most advanced quality and safety requirements.
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About the Company : Founded in 2000, YONSUNG fine chemicals co., Ltd. is a top quality, fast growing manufacturer of APIs, especially, PROSTAGLANDINS and related products for pharmaceutical applicatio...

Founded in 2000, YONSUNG fine chemicals co., Ltd. is a top quality, fast growing manufacturer of APIs, especially, PROSTAGLANDINS and related products for pharmaceutical applications. YONSUNG prides itself on the quality of its products, which gives the company an important competitive edge. The site manufactures API,s for the US, EU and other regulated markets and complies with the cGMP guidelines established by ICH (Q7A). The relevance of new requirements from the FDA, ICH, EMEA and EDQM is continuously monitored.Stringent controls are built-in to ensure that every single product meets the specification of most known pharmacopeias.
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About the Company : Founded in 2010, Ausun Pharmaceutical is a public company, specialized in high-tech. threshold Generic API Dev. & providing CDMO services. Ausun owns & operates 1 on-site R&D Cente...

Founded in 2010, Ausun Pharmaceutical is a public company, specialized in high-tech. threshold Generic API Dev. & providing CDMO services. Ausun owns & operates 1 on-site R&D Center & 1 Mfg. Site which has been certified by US FDA, JPMDA & EMA, supported by >550 highly trained professionals across departments & >200 scientists to bring high quality products to customers. More than 130 products/projects have been successfully developed since founded. Process Innovation, R&D Efficiency & Cost Effectiveness are Ausun's key competencies. Create Chemistry and to be the 1st Class Worldwide Pharmaceutical Corporation is our goal.
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Drugs in Development

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Details:

Aurlumyn (iloprost) is a prostanoid IP receptor agonist, acts as vasodilator that opens blood vessels and stops blood clotting. It is indicated for the treatment of severe frostbite in adults.


Lead Product(s): Iloprost

Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Aurlumyn

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 14, 2024

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Details : Aurlumyn (iloprost) is a prostanoid IP receptor agonist, acts as vasodilator that opens blood vessels and stops blood clotting. It is indicated for the treatment of severe frostbite in adults.

Product Name : Aurlumyn

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 14, 2024

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Details:

The funding will support the initiative by Danish researchers and researchers from BioPorto A/S, to test if evaIloprost (prostacyclin) can potentially reduce damage to the capillaries and counteract ARDS to increase survival rates in COVID-19 patients.


Lead Product(s): Iloprost

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Other Small Molecule

Sponsor: Innovation Fund Denmark

Deal Size: $0.4 million Upfront Cash: Undisclosed

Deal Type: Funding May 14, 2020

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Rigshospitalet

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Details : The funding will support the initiative by Danish researchers and researchers from BioPorto A/S, to test if evaIloprost (prostacyclin) can potentially reduce damage to the capillaries and counteract ARDS to increase survival rates in COVID-19 patients.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

May 14, 2020

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Details:

The AURORA study is a multicenter, double-blind, randomized, placebo-controlled, Phase 3 study evaluating the safety and efficacy of intravenous (IV) iloprost in patients with SSc experiencing symptomatic digital ischemic episodes (symptomatic Raynaud's Phenomenon).


Lead Product(s): Iloprost

Therapeutic Area: Immunology Brand Name: CIVI030

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 10, 2020

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Details : The AURORA study is a multicenter, double-blind, randomized, placebo-controlled, Phase 3 study evaluating the safety and efficacy of intravenous (IV) iloprost in patients with SSc experiencing symptomatic digital ischemic episodes (symptomatic Raynaud's ...

Product Name : CIVI030

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 10, 2020

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Price Per Pack (Euro) : 260.40

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Dosage Form : Concentrate to the infusion flui...

Dosage Strength : 20 mcg/ml

Price Per Pack (Euro) : 415.73

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Iloprost

Dosage Form : Iloprost 20Mcg 2Ml 30 Joined' Re...

Dosage Strength : 30 ampoules soluz nebul 2 ml 10 mcg/ml

Price Per Pack (Euro) : 1,411.09

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Iloprost

Dosage Form : Iloprost 20Mcg 2Ml 90 Units Resp...

Dosage Strength : 3x30 vials nebul soluz 2 ml 10 mcg/ml

Price Per Pack (Euro) : 4,233.30

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RX/OTC/DISCN : Class A

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Iloprost

Dosage Form : Inf Konz

Dosage Strength : 20mcg/ml

Price Per Pack (Euro) : 33.85

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Iloprost

Dosage Form : Inf Konz

Dosage Strength : 50mcg/2.5ml

Price Per Pack (Euro) : 68.27

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Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ventavis

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Iloprost

Dosage Form : Inhal L?s

Dosage Strength : 20mcg/2ml

Price Per Pack (Euro) : 803.47

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Wait newspaper

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Iloprost

Dosage Form : Inhalasjonsvaeske to nebulisator...

Dosage Strength : 10 mcg/ml

Price Per Pack (Euro) : 3,181.41

Published in :

Country : Norway

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Brand Name : Wait newspaper

Germany
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Brand Name : Wait newspaper

Germany
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Iloprost

Dosage Form : Inhalasjonsvaeske to nebulisator...

Dosage Strength : 10 mcg/ml

Price Per Pack (Euro) : 3,222.93

Published in :

Country : Norway

RX/OTC/DISCN :

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10

Brand Name : Wait newspaper

Germany
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Brand Name : Wait newspaper

Germany
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Iloprost

Dosage Form : Inhalasjonsvaeske to nebulisator...

Dosage Strength : 10 mcg/ml

Price Per Pack (Euro) : 3,580.50

Published in :

Country : Norway

RX/OTC/DISCN :

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Annual Reports

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Brand Name : Ventavis

Iloprost

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Iloprost

Main Therapeutic Indication : Cardiovascular Diseases

Currency : USD

2016 Revenue in Millions : 72

2015 Revenue in Millions : 104

Growth (%) : -30

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BTG INTL

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ILOPROST

Exclusivity Code : NP

Exclusivity Expiration Date : 2027-02-13

Application Number : 217933

Product Number : 1

Exclusivity Details :

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BTG INTL

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ILOPROST

Exclusivity Code : ODE-465

Exclusivity Expiration Date : 2031-02-13

Application Number : 217933

Product Number : 1

Exclusivity Details :

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Looking for 78919-13-8 / Iloprost API manufacturers, exporters & distributors?

Iloprost manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Iloprost 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 Iloprost manufacturer or Iloprost supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iloprost manufacturer or Iloprost supplier.

PharmaCompass also assists you with knowing the Iloprost API Price utilized in the formulation of products. Iloprost API Price is not always fixed or binding as the Iloprost Price is obtained through a variety of data sources. The Iloprost Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Iloprost

Synonyms

Ciloprost, Ventavis, Endoprost, Ilomedin, 78919-13-8, Iloprostum

Cas Number

78919-13-8

Unique Ingredient Identifier (UNII)

JED5K35YGL

About Iloprost

An eicosanoid, derived from the cyclooxygenase pathway of arachidonic acid metabolism. It is a stable and synthetic analog of EPOPROSTENOL, but with a longer half-life than the parent compound. Its actions are similar to prostacyclin. Iloprost produces vasodilation and inhibits platelet aggregation.

Ventavis Manufacturers

A Ventavis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ventavis, including repackagers and relabelers. The FDA regulates Ventavis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ventavis 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 Ventavis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ventavis Suppliers

A Ventavis supplier is an individual or a company that provides Ventavis active pharmaceutical ingredient (API) or Ventavis finished formulations upon request. The Ventavis suppliers may include Ventavis API manufacturers, exporters, distributors and traders.

click here to find a list of Ventavis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ventavis USDMF

A Ventavis DMF (Drug Master File) is a document detailing the whole manufacturing process of Ventavis active pharmaceutical ingredient (API) in detail. Different forms of Ventavis DMFs exist exist since differing nations have different regulations, such as Ventavis USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ventavis DMF submitted to regulatory agencies in the US is known as a USDMF. Ventavis USDMF includes data on Ventavis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ventavis USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ventavis suppliers with USDMF on PharmaCompass.

Ventavis 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 Ventavis as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ventavis 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 Ventavis 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 Ventavis and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ventavis NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ventavis suppliers with NDC on PharmaCompass.

Ventavis GMP

Ventavis 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 Ventavis 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 Ventavis GMP manufacturer or Ventavis GMP API supplier for your needs.

Ventavis CoA

A Ventavis CoA (Certificate of Analysis) is a formal document that attests to Ventavis's compliance with Ventavis specifications and serves as a tool for batch-level quality control.

Ventavis CoA mostly includes findings from lab analyses of a specific batch. For each Ventavis 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.

Ventavis may be tested according to a variety of international standards, such as European Pharmacopoeia (Ventavis EP), Ventavis JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ventavis 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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