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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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01

HRV Global Life Sciences

India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
HRV Global Life Sciences

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Viyash Life Sciences

India

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

Specialty & Agro Chemical
Not Confirmed
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Ash Stevens

U.S.A

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

Specialty & Agro Chemical
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Ash Stevens

U.S.A

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Hefei Home Sunshine Pharmaceutical...

China

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Hefei Home Sunshine Pharmaceutical...

China

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Lee Pharma

India

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

Specialty & Agro Chemical
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Lee Pharma

India

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

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NDC API

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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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Listed Suppliers

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

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Digital Content Digital Content

Seladelpar Lysine

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.
HRV Global Life Sciences

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Specialty & Agro Chemical
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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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Lee Pharma

India
Specialty & Agro Chemical
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Lee Pharma

India
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Seladelpar Lysine

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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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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Drugs in Development

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Details:

Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).


Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 20, 2025

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01

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
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Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 20, 2025

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Details:

Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).


Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 13, 2024

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02

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 13, 2024

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Details:

Gilead expands its liver portfolio with CymaBay’s MBX-8025 (seladelpar), a PPARδ agonist for primary biliary cholangitis.


Lead Product(s): Seladelpar Lysine

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: MBX-8025

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Gilead Sciences

Deal Size: $4,300.0 million Upfront Cash: $4,300.0 million

Deal Type: Acquisition December 02, 2024

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03

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : Gilead expands its liver portfolio with CymaBay’s MBX-8025 (seladelpar), a PPARδ agonist for primary biliary cholangitis.

Product Name : MBX-8025

Product Type : Other Small Molecule

Upfront Cash : $4,300.0 million

December 02, 2024

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Details:

MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.


Lead Product(s): Seladelpar Lysine

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: MBX-8025

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 02, 2024

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04

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.

Product Name : MBX-8025

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 02, 2024

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Details:

The partnership aims for the distribution of a novel selective, first-in-class, PPAR delta agonist, Livdelzi (seladelpar), to treat adults with primary biliary cholangitis (PBC).


Lead Product(s): Seladelpar Lysine

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Gilead Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership August 16, 2024

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05

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : The partnership aims for the distribution of a novel selective, first-in-class, PPAR delta agonist, Livdelzi (seladelpar), to treat adults with primary biliary cholangitis (PBC).

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

August 16, 2024

blank

Details:

Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).


Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 15, 2024

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06

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 15, 2024

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Details:

Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.


Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Gilead Sciences

Deal Size: $320.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 08, 2024

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07

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

August 08, 2024

blank

Details:

MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor delta agonist being evaluated for treating primary biliary cholangitis.


Lead Product(s): Seladelpar Lysine

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 18, 2024

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08

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor delta agonist being evaluated for treating primary biliary cholangitis.

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 18, 2024

blank

Details:

MBX-8025 (seladelpar) is an investigational first-in-class oral, selective PPAR delta agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.


Lead Product(s): Seladelpar Lysine

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 06, 2024

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09

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : MBX-8025 (seladelpar) is an investigational first-in-class oral, selective PPAR delta agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 06, 2024

blank

Details:

MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.


Lead Product(s): Seladelpar Lysine

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: MBX-8025

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 03, 2024

blank

10

Specialty & Agro Chemical
Not Confirmed
Specialty & Agro Chemical
Not Confirmed

Details : MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.

Product Name : MBX-8025

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 03, 2024

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FDA Orange Book

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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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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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https://www.businesswire.com/news/home/20250506771103/en/Gileads-Livdelzi-Seladelpar-Demonstrated-Consistent-Efficacy-and-Safety-Regardless-of-Prior-Treatment-History-in-New-Data-Presented-at-EASL-2025

BUSINESSWIRE
07 May 2025

https://www.fiercepharma.com/pharma/ipsens-liver-disease-drug-iqirvo-promising-launch-battle-gileads-livdelzi

FIERCE PHARMA
17 Apr 2025

https://www.businesswire.com/news/home/20250213709259/en

BUSINESSWIRE
20 Feb 2025

https://www.businesswire.com/news/home/20241212516221/en

BUSINESSWIRE
13 Dec 2024

https://www.businesswire.com/news/home/20241114931214/en

BUSINESSWIRE
15 Nov 2024

https://www.fiercepharma.com/pharma/fda-approval-livdelzi-gilead-launches-inflammatory-drug-first-time

FIERCE PHARMA
16 Aug 2024

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Patents & EXCLUSIVITIES

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US Patents

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SELADELPAR LYSINE

US Patent Number : 7301050

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217899

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-08-02

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SELADELPAR LYSINE

US Patent Number : 11596614

Drug Substance Claim :

Drug Product Claim :

Application Number : 217899

Patent Use Code : U-1854

Delist Requested :

Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2035-03-19

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SELADELPAR LYSINE

US Patent Number : 11406611

Drug Substance Claim :

Drug Product Claim :

Application Number : 217899

Patent Use Code : U-1854

Delist Requested :

Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2035-03-19

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SELADELPAR LYSINE

US Patent Number : 10272058

Drug Substance Claim :

Drug Product Claim :

Application Number : 217899

Patent Use Code : U-1854

Delist Requested :

Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2035-03-19

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SELADELPAR LYSINE

US Patent Number : 9486428

Drug Substance Claim :

Drug Product Claim :

Application Number : 217899

Patent Use Code : U-1854

Delist Requested :

Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2035-03-19

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SELADELPAR LYSINE

US Patent Number : 7709682

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217899

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-09-13

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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 Manufacturers

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

Seladelpar Suppliers

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

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

Seladelpar 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Seladelpar GMP

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

Seladelpar CoA

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

Seladelpar CoA mostly includes findings from lab analyses of a specific batch. For each Seladelpar 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Seladelpar EP), Seladelpar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Seladelpar 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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