Find Seladelpar Lysine manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

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REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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DRUG PRODUCT COMPOSITIONS

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Health Canada Patents

API REF. PRICE (USD/KG)

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US Medicaid

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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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HRV Global Life Sciences

India

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Ash Stevens

U.S.A

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

APS Symposium
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Ash Stevens

U.S.A

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Lee Pharma

India

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Lee Pharma

India

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Viyash Life Sciences

India

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APS Symposium
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Hefei Home Sunshine Pharmaceutical...

China

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NDC API

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DIA 2025
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DIA 2025
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SELADELPAR LYSINE

NDC Package Code : 48957-0106

Start Marketing Date : 2024-08-14

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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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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