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Chemistry

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Also known as: Lopixibat chloride, 228113-66-4, Lum-001, Maralixibat chloride [usan], Lum001, Maralixibat (chloride)
Molecular Formula
C40H56ClN3O4S
Molecular Weight
710.4  g/mol
InChI Key
POMVPJBWDDJCMP-RUKDTIIFSA-M
FDA UNII
V78M04F0XC

Maralixibat Chloride
1 2D Structure

Maralixibat Chloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,5R)-5-[4-[[4-(4-aza-1-azoniabicyclo[2.2.2]octan-1-ylmethyl)phenyl]methoxy]phenyl]-3,3-dibutyl-7-(dimethylamino)-1,1-dioxo-4,5-dihydro-2H-16-benzothiepin-4-ol;chloride
2.1.2 InChI
InChI=1S/C40H56N3O4S.ClH/c1-5-7-19-40(20-8-6-2)30-48(45,46)37-18-15-34(41(3)4)27-36(37)38(39(40)44)33-13-16-35(17-14-33)47-29-32-11-9-31(10-12-32)28-43-24-21-42(22-25-43)23-26-43;/h9-18,27,38-39,44H,5-8,19-26,28-30H2,1-4H3;1H/q+1;/p-1/t38-,39-;/m1./s1
2.1.3 InChI Key
POMVPJBWDDJCMP-RUKDTIIFSA-M
2.1.4 Canonical SMILES
CCCCC1(CS(=O)(=O)C2=C(C=C(C=C2)N(C)C)C(C1O)C3=CC=C(C=C3)OCC4=CC=C(C=C4)C[N+]56CCN(CC5)CC6)CCCC.[Cl-]
2.1.5 Isomeric SMILES
CCCCC1(CS(=O)(=O)C2=C(C=C(C=C2)N(C)C)[C@H]([C@H]1O)C3=CC=C(C=C3)OCC4=CC=C(C=C4)C[N+]56CCN(CC5)CC6)CCCC.[Cl-]
2.2 Other Identifiers
2.2.1 UNII
V78M04F0XC
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (4r,5r)-5-(4-((4-(4-aza-1-azoniabicyclo(2.2.2)octan-1-ylmethyl)phenyl)methoxy)phenyl)-3,3-dibutyl-7-(dimethylamino)-1,1-dioxo-4,5-dihydro-2h-16-benzothiepin-4-ol

2. Livmarli

3. Maralixibat

2.3.2 Depositor-Supplied Synonyms

1. Lopixibat Chloride

2. 228113-66-4

3. Lum-001

4. Maralixibat Chloride [usan]

5. Lum001

6. Maralixibat (chloride)

7. V78m04f0xc

8. 228113-66-4 (chloride)

9. Livmarli

10. Lum 001

11. 4-aza-1-azoniabicyclo(2.2.2)octane, 1-((4-((4-((4r,5r)-3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl)phenoxy)methyl)phenyl)methyl)-, Chloride (1:1)

12. Chembl17879

13. (4r,5r)-5-[4-[[4-(4-aza-1-azoniabicyclo[2.2.2]octan-1-ylmethyl)phenyl]methoxy]phenyl]-3,3-dibutyl-7-(dimethylamino)-1,1-dioxo-4,5-dihydro-2h-1lambda6-benzothiepin-4-ol;chloride

14. 1-(4-((4-((4r,5r)-3,3-dibutyl-7-(dimethylamino)-4-hydroxy-1,1-dioxido-2,3,4,5-tetrahydrobenzo[b]thiepin-5-yl)phenoxy)methyl)benzyl)-1,4-diazabicyclo[2.2.2]octan-1-ium Chloride

15. Lopixibat Chloride [inn]

16. Unii-v78m04f0xc

17. Shp 625

18. Schembl6336189

19. Shp625

20. Maralixibat Chloride (usan/inn)

21. Dtxsid701337104

22. Maralixibat Chloride [inn]

23. Maralixibat Chloride [who-dd]

24. Hy-16747

25. Maralixibat Chloride [orange Book]

26. Cs-0012347

27. D10952

28. Q27291628

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 710.4 g/mol
Molecular Formula C40H56ClN3O4S
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count13
Exact Mass709.3680061 g/mol
Monoisotopic Mass709.3680061 g/mol
Topological Polar Surface Area78.5 Ų
Heavy Atom Count49
Formal Charge0
Complexity1080
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 Progressive Familial Intrahepatic Cholestasis


Treatment of Alagille syndrome


Treatment of biliary atresia


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Ileal Bile Acid Transporter Inhibitors [MoA]; Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]; Ileal Bile Acid Transporter Inhibitor [EPC]
5.2 ATC Code

A - Alimentary tract and metabolism

A05 - Bile and liver therapy

A05A - Bile therapy

A05AX - Other drugs for bile therapy

A05AX04 - Maralixibat chloride


NDC API

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AMWC Asia-TDAC
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MARALIXIBAT CHLORIDE

NDC Package Code : 76397-040

Start Marketing Date : 2025-03-17

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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Lee Pharma

India
AMWC Asia-TDAC
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Lee Pharma

India
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Maralixibat Chloride

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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API Reference Price

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10-Feb-2024
03-Mar-2025
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Drugs in Development

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Details:

Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 3 month of age and older.


Lead Product(s): Maralixibat Chloride

Therapeutic Area: Genetic Disease Brand Name: Livmarli

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 14, 2025

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01

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 3 month of age and older.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 14, 2025

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Details:

Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older.


Lead Product(s): Maralixibat Chloride

Therapeutic Area: Genetic Disease Brand Name: Livmarli

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 27, 2025

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02

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 27, 2025

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Details:

Under the agreement, Mirum has appointed Abacus to exclusively promote, market, sell, distribute, and commercialize LIVMARLI in the territory of Denmark, Finland, Iceland, Norway, and Sweden.


Lead Product(s): Maralixibat Chloride

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

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Abacus Medicine

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement September 09, 2024

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03

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Under the agreement, Mirum has appointed Abacus to exclusively promote, market, sell, distribute, and commercialize LIVMARLI in the territory of Denmark, Finland, Iceland, Norway, and Sweden.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

September 09, 2024

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Details:

LIVMARLI® (maralixibat) oral solution is a minimally absorbed IBAT inhibitor, approved for treating of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.


Lead Product(s): Maralixibat Chloride

Therapeutic Area: Genetic Disease Brand Name: Livmarli

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 07, 2024

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04

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : LIVMARLI® (maralixibat) oral solution is a minimally absorbed IBAT inhibitor, approved for treating of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 07, 2024

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Details:

Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, approved for PFIC patients 12 months and older in higher concentrations.


Lead Product(s): Maralixibat Chloride

Therapeutic Area: Genetic Disease Brand Name: Livmarli

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 25, 2024

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05

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, approved for PFIC patients 12 months and older in higher concentrations.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 25, 2024

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Details:

Livmarli (maralixibat) is an oral IBAT inhibitor, which is under clinical development for the treatment of Progressive Familial Intrahepatic Cholestasis.


Lead Product(s): Maralixibat Chloride

Therapeutic Area: Genetic Disease Brand Name: Livmarli

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 31, 2024

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06

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli (maralixibat) is an oral IBAT inhibitor, which is under clinical development for the treatment of Progressive Familial Intrahepatic Cholestasis.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 31, 2024

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Details:

LIVMARLI® (maralixibat), an IBAT inhibitor, has FDA approval for cholestatic pruritus in progressive familial intrahepatic cholestasis.


Lead Product(s): Maralixibat Chloride

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

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 13, 2024

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07

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : LIVMARLI® (maralixibat), an IBAT inhibitor, has FDA approval for cholestatic pruritus in progressive familial intrahepatic cholestasis.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 13, 2024

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Details:

Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, which is under phase 2 clinical development for the treatment of Biliary Atresia.


Lead Product(s): Maralixibat Chloride

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

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 18, 2023

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08

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, which is under phase 2 clinical development for the treatment of Biliary Atresia.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 18, 2023

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Details:

Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of biliary atresia in infant who have previously undergone a hepatoportoenterostomy.


Lead Product(s): Maralixibat Chloride

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

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 05, 2023

blank

09

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of biliary atresia in infant who have previously undergone a hepatoportoenterostomy.

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 05, 2023

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Details:

Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and NMPA has accepted the New Drug Application for the treatment of Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis.


Lead Product(s): Maralixibat Chloride

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

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 17, 2023

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10

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and NMPA has accepted the New Drug Application for the treatment of Cholestatic Pruritus in Progressive Familial Intrahepatic Cholest...

Product Name : Livmarli

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 17, 2023

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FDF Dossiers

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AMWC Asia-TDAC
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MARALIXIBAT CHLORIDE

Brand Name : LIVMARLI

Dosage Form : SOLUTION;ORAL

Dosage Strength : EQ 9.5MG BASE/ML

Packaging :

Approval Date : 2021-09-29

Application Number : 214662

Regulatory Info : RX

Registration Country : USA

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MARALIXIBAT CHLORIDE

Brand Name : LIVMARLI

Dosage Form : SOLUTION;ORAL

Dosage Strength : EQ 19MG BASE/ML

Packaging :

Approval Date : 2024-07-24

Application Number : 214662

Regulatory Info : RX

Registration Country : USA

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ABOUT THIS PAGE

Looking for 228113-66-4 / Maralixibat Chloride API manufacturers, exporters & distributors?

Maralixibat Chloride manufacturers, exporters & distributors 1

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

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

API | Excipient name

Maralixibat Chloride

Synonyms

Lopixibat chloride, 228113-66-4, Lum-001, Maralixibat chloride [usan], Lum001, Maralixibat (chloride)

Cas Number

228113-66-4

Unique Ingredient Identifier (UNII)

V78M04F0XC

Maralixibat Chloride Manufacturers

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

Maralixibat Chloride Suppliers

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

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

Maralixibat Chloride USDMF

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

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

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

Maralixibat Chloride 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 Maralixibat Chloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Maralixibat Chloride GMP

Maralixibat Chloride 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 Maralixibat Chloride 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 Maralixibat Chloride GMP manufacturer or Maralixibat Chloride GMP API supplier for your needs.

Maralixibat Chloride CoA

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

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

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