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Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: Mbx-8025 lysine, Seladelpar lysine dihydrate, Mbx-8025 lysine dihydrate, 928821-40-3, Seladelpar lysine [usan], Mbx-8025 lysine salt, dihydrate
Molecular Formula
C27H41F3N2O9S
Molecular Weight
626.7  g/mol
InChI Key
WTKSWPYGZDCUNQ-JZXFCXSPSA-N
FDA UNII
N1429130KR

Seladelpar Lysine
1 2D Structure

Seladelpar Lysine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2,6-diaminohexanoic acid;2-[4-[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]sulfanyl-2-methylphenoxy]acetic acid;dihydrate
2.1.2 InChI
InChI=1S/C21H23F3O5S.C6H14N2O2.2H2O/c1-3-27-17(11-28-16-6-4-15(5-7-16)21(22,23)24)13-30-18-8-9-19(14(2)10-18)29-12-20(25)26;7-4-2-1-3-5(8)6(9)10;;/h4-10,17H,3,11-13H2,1-2H3,(H,25,26);5H,1-4,7-8H2,(H,9,10);2*1H2/t17-;5-;;/m10../s1
2.1.3 InChI Key
WTKSWPYGZDCUNQ-JZXFCXSPSA-N
2.1.4 Canonical SMILES
CCOC(COC1=CC=C(C=C1)C(F)(F)F)CSC2=CC(=C(C=C2)OCC(=O)O)C.C(CCN)CC(C(=O)O)N.O.O
2.1.5 Isomeric SMILES
CCO[C@H](COC1=CC=C(C=C1)C(F)(F)F)CSC2=CC(=C(C=C2)OCC(=O)O)C.C(CCN)C[C@@H](C(=O)O)N.O.O
2.2 Other Identifiers
2.2.1 UNII
N1429130KR
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Mbx-8025 Lysine

2. Seladelpar Lysine Dihydrate

3. Mbx-8025 Lysine Dihydrate

4. 928821-40-3

5. Seladelpar Lysine [usan]

6. Mbx-8025 Lysine Salt, Dihydrate

7. N1429130kr

8. Seladelpar (lysine Dihydrate)

9. Unii-n1429130kr

10. Seladelpar Lysine (usan)

11. Chembl3989960

12. Wtkswpygzdcunq-jzxfcxspsa-n

13. Hy-19522c

14. Akos040747473

15. Cs-1068545

16. D11257

17. Q27284370

18. (2s)-2,6-diaminohexanoic Acid;2-[4-[(2r)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]sulfanyl-2-methylphenoxy]acetic Acid;dihydrate

19. (r)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic Acid Compound With (s)-2,6-diaminohexanoic Acid Dihydrate

20. L-lysine (4-(((2r)-2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)sulfanyl)-2-methylphenoxy)acetate Dihydrate

21. L-lysine, 2-(4-(((2r)-2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetate, Hydrate (1:1:2)

2.3.2 Other Synonyms

1. 851528-79-5

2. Mbx-8025

3. Mbx-8025 (seladelpar)

4. Seladelpar

2.4 Create Date
2015-06-01
3 Chemical and Physical Properties
Molecular Weight 626.7 g/mol
Molecular Formula C27H41F3N2O9S
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count15
Rotatable Bond Count16
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area182
Heavy Atom Count42
Formal Charge0
Complexity617
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4

API SUPPLIERS

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PPL Pharma Solutions Riverview LLC

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SELADELPAR LYSINE

NDC Package Code : 48957-0106

Start Marketing Date : 2024-08-14

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Seladelpar Lysine

About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
Biophore

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Seladelpar Lysine

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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HRV Pharma

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  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Seladelpar Lysine

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences

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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Seladelpar Lysine

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Seladelpar Lysine

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 unmet medical needs t...

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 unmet medical needs through our integrated expertise in Contract Research Organization (CRO) services, CARMS, New Chemical Entities (NCEs), and Generic APIs. Our core business encompasses comprehensive chemistry services and the manufacturing of essential Key Starting Materials (KSMs) and pharmaceutical intermediates.
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Seladelpar Lysine

About the Company : Erythro Pharma specializes in large-scale custom chemical manufacturing for pharmaceutical, agrochemical, specialty and fine chemical sectors. The organization delivers integrated ...

Erythro Pharma specializes in large-scale custom chemical manufacturing for pharmaceutical, agrochemical, specialty and fine chemical sectors. The organization delivers integrated development-to-commercial services and supplies advanced API intermediates, specialty chemicals and fine chemicals in a cost-effective manner. With 30+ years of technical strength, strong safety practices and a robust raw-material supply network, Erythro Pharma supports global partners with reliable, high-quality solutions.
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Seladelpar

About the Company : Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured ...

Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured because of our continuously-optimizing management and technology innovation, complete QA system, advanced testing methods and equipments. We have won the trust of a wide range of customers/partners in the industry. Our Products include active pharmaceutical ingredients (API), pharmaceutical and agrochemical intermediates and chiral compounds.
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Seladelpar Lysine

About the Company : Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, ...

Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, APIs and advanced intermediates Viyash and its subsidiaries operate 10 API / Intermediate facilities with a combined capacity ~2000 KL and diversified capabilities in every aspect - small / large volume, potent / non-potent, regulated / semi-regulated markets. In addition, we also operate one formulation manufacturing facility in New Jersey, USA with a capacity of ~ 1.2 Bn units.
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Seladelpar Lysine

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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SELADELPAR LYSINE

Brand Name : LIVDELZI

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2024-08-14

Application Number : 217899

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Canada

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Seladelpar Lysine

Brand Name : LYVDELZI

Dosage Form : CAPSULE

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2561492

Regulatory Info : Prescription

Registration Country : Canada

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Patents & EXCLUSIVITIES

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US Exclusivities

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SELADELPAR LYSINE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2029-08-14

Application Number : 217899

Product Number : 1

Exclusivity Details :

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SELADELPAR LYSINE

Exclusivity Code : ODE-486

Exclusivity Expiration Date : 2031-08-14

Application Number : 217899

Product Number : 1

Exclusivity Details :

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ABOUT THIS PAGE

Looking for 928821-40-3 / Seladelpar Lysine API manufacturers, exporters & distributors?

Seladelpar Lysine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Seladelpar Lysine

Synonyms

Mbx-8025 lysine, Seladelpar lysine dihydrate, Mbx-8025 lysine dihydrate, 928821-40-3, Seladelpar lysine [usan], Mbx-8025 lysine salt, dihydrate

Cas Number

928821-40-3

Unique Ingredient Identifier (UNII)

N1429130KR

Seladelpar Lysine Manufacturers

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

Seladelpar Lysine Suppliers

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

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

Seladelpar Lysine 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 Seladelpar Lysine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Seladelpar Lysine GMP

Seladelpar Lysine 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 Seladelpar Lysine 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 Seladelpar Lysine GMP manufacturer or Seladelpar Lysine GMP API supplier for your needs.

Seladelpar Lysine CoA

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

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

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