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Chemistry

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Also known as: Treprostinil diethanolamine, 830354-48-8, Ut-15c, Treprostinil diolamin, Treprostinil diolamine [usan], Treprostinil (diethanolamine)
Molecular Formula
C27H45NO7
Molecular Weight
495.6  g/mol
InChI Key
RHWRWEUCEXUUAV-ZSESPEEFSA-N
FDA UNII
H1FKG90039

Treprostinil Diolamine
1 2D Structure

Treprostinil Diolamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid;2-(2-hydroxyethylamino)ethanol
2.1.2 InChI
InChI=1S/C23H34O5.C4H11NO2/c1-2-3-4-7-17(24)9-10-18-19-11-15-6-5-8-22(28-14-23(26)27)20(15)12-16(19)13-21(18)25;6-3-1-5-2-4-7/h5-6,8,16-19,21,24-25H,2-4,7,9-14H2,1H3,(H,26,27);5-7H,1-4H2/t16-,17-,18+,19-,21+;/m0./s1
2.1.3 InChI Key
RHWRWEUCEXUUAV-ZSESPEEFSA-N
2.1.4 Canonical SMILES
CCCCCC(CCC1C(CC2C1CC3=C(C2)C(=CC=C3)OCC(=O)O)O)O.C(CO)NCCO
2.1.5 Isomeric SMILES
CCCCC[C@@H](CC[C@H]1[C@@H](C[C@H]2[C@@H]1CC3=C(C2)C(=CC=C3)OCC(=O)O)O)O.C(CO)NCCO
2.2 Other Identifiers
2.2.1 UNII
H1FKG90039
2.3 Synonyms
2.3.1 MeSH Synonyms

1. ((1r,2r,3as,9as)-2-hydroxy-1-((3s)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cylopent(b)naphthalen-5-yl)oxy)acetate

2. Orenitram

3. Remodulin

4. Trepostinil Sodium

5. Treprostinil

6. Treprostinil Diethanolamine

7. Treprostinil Diolamin

8. Treprostinil Sodium

9. Ut-15

10. Ut-15c

2.3.2 Depositor-Supplied Synonyms

1. Treprostinil Diethanolamine

2. 830354-48-8

3. Ut-15c

4. Treprostinil Diolamin

5. Treprostinil Diolamine [usan]

6. Treprostinil (diethanolamine)

7. H1fkg90039

8. 2-((1r,2r,3as,9as)-2-hydroxy-1-(3(s)-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta(b)naphthalen-5-yloxy)acetic Acid Diethanolamine Salt

9. Acetic Acid, 2-(((1r,2r,3as,9as)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3s)-3-hydroxyoctyl)-1h-benz(f)inden-5-yl)oxy)-, Compd. With 2,2'-iminobis(ethanol) (1:1)

10. Treprostinil Diolamine (usan)

11. 2-[[(1r,2r,3as,9as)-2-hydroxy-1-[(3s)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[g]naphthalen-5-yl]oxy]acetic Acid;2-(2-hydroxyethylamino)ethanol

12. Unii-h1fkg90039

13. Orenitram (tn)

14. Chembl2107815

15. Schembl17222566

16. Dtxsid50232132

17. Ex-a1418

18. Hy-b0813

19. Treprostinil Diolamin [who-dd]

20. Treprostinil Diolamine [orange Book]

21. Cs-0012733

22. D10430

23. Q27279501

24. 2-(((1r,2r,3as,9as)-2-hydroxy-1-((s)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[b]naphthalen-5-yl)oxy)acetic Acid Diethanolamine Salt

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 495.6 g/mol
Molecular Formula C27H45NO7
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count8
Rotatable Bond Count14
Exact Mass495.31960277 g/mol
Monoisotopic Mass495.31960277 g/mol
Topological Polar Surface Area140 Ų
Heavy Atom Count35
Formal Charge0
Complexity524
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Treatment of pulmonary hypertension


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2017-03-17

Pay. Date : 2017-02-13

DMF Number : 31385

Submission : 2017-02-28

Status : Active

Type : II

Nuray Chemicals

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Apotex Pharmachem Inc

Canada

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DMF Review : Complete

Rev. Date : 2018-03-09

Pay. Date : 2017-09-27

DMF Number : 32086

Submission : 2017-10-05

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2016-11-18

Pay. Date : 2016-06-16

DMF Number : 30535

Submission : 2016-04-28

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2016-01-08

Pay. Date : 2015-12-14

DMF Number : 30000

Submission : 2015-12-06

Status : Active

Type : II

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EU WC

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Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Treprostinil Diolamine IH

Date of Issue : 2024-02-20

Valid Till : 2026-12-06

Written Confirmation Number : WC-0416

Address of the Firm : Plot No. 111, SIDCO Industrial Estate, Kakkalur, Thiruvallur 602 003, Tamil Nadu...

Nuray Chemicals
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Virtual BoothChirogate is a professional Prostaglandin manufacturer.

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Treprostinil Diolamine

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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Treprostinil Diolamine

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
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EUROAPI

France
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Treprostinil Diolamine

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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Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Treprostinil Diolamine

About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
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HRV Pharma

India
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Treprostinil Diolamine

About the Company : HRV Pharma 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 Pharma 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 Pharma effectively promote projects and products. HRV Pharma represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Pharma has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Treprostinil Diolamine

About the Company : Founded in 1972, and public listed in Taiwan Stock Exchange in 1988, Everlight Chemical focuses on the development of chemical synthesis technology, which gradually became its core...

Founded in 1972, and public listed in Taiwan Stock Exchange in 1988, Everlight Chemical focuses on the development of chemical synthesis technology, which gradually became its core competency. Today the company’s main product lines include: Color Chemicals, Specialty Chemicals, Toner, Electronic Chemicals, Pharmaceutical Chemicals, and Nano-Materials. Having a total of 17 operating locations and 6 production bases around the world, it employs approximately 1,900 employees. In 2017, its revenue approximately was USD300M (NT 9.2 billion).
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Viatris

U.S.A
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About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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API Reference Price

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11-Oct-2023
21-Apr-2025
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0.125MG BASE

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ABOUT THIS PAGE

Looking for 830354-48-8 / Treprostinil Diolamine API manufacturers, exporters & distributors?

Treprostinil Diolamine manufacturers, exporters & distributors 1

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

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

API | Excipient name

Treprostinil Diolamine

Synonyms

Treprostinil diethanolamine, 830354-48-8, Ut-15c, Treprostinil diolamin, Treprostinil diolamine [usan], Treprostinil (diethanolamine)

Cas Number

830354-48-8

Unique Ingredient Identifier (UNII)

H1FKG90039

Treprostinil Diolamine Manufacturers

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

Treprostinil Diolamine Suppliers

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

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

Treprostinil Diolamine USDMF

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

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

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

Treprostinil Diolamine WC

A Treprostinil Diolamine written confirmation (Treprostinil Diolamine WC) is an official document issued by a regulatory agency to a Treprostinil Diolamine manufacturer, verifying that the manufacturing facility of a Treprostinil Diolamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Treprostinil Diolamine APIs or Treprostinil Diolamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Treprostinil Diolamine WC (written confirmation) as part of the regulatory process.

click here to find a list of Treprostinil Diolamine suppliers with Written Confirmation (WC) on PharmaCompass.

Treprostinil Diolamine 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 Treprostinil Diolamine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Treprostinil Diolamine GMP

Treprostinil Diolamine 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 Treprostinil Diolamine 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 Treprostinil Diolamine GMP manufacturer or Treprostinil Diolamine GMP API supplier for your needs.

Treprostinil Diolamine CoA

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

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

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