Find Fexuprazan manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Related ProductsRelated Products

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

NDC API

NDC API

0

VMF

NDC API

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

FDF Dossiers

FDF Dossiers

0

FDA Orange Book

FDA (Orange Book)

0

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

API REF. PRICE (USD/KG)

$
$ 0

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

Regulatory FDF Prices

NA

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

0

API

0

FDF

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Fexuprazan, 1902954-60-2, Dwp14012, Dwp-14012, Be52s2c1qt, 1-[5-(2,4-difluorophenyl)-1-(3-fluorobenzene-1-sulfonyl)-4-methoxy-1h-pyrrol-3-yl]-n-methylmethanamine
Molecular Formula
C19H17F3N2O3S
Molecular Weight
410.4  g/mol
InChI Key
OUNXGNDVWVPCOL-UHFFFAOYSA-N
FDA UNII
BE52S2C1QT

Fexuprazan
Abeprazan is under investigation in clinical trial NCT04341454 (Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis).
1 2D Structure

Fexuprazan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[5-(2,4-difluorophenyl)-1-(3-fluorophenyl)sulfonyl-4-methoxypyrrol-3-yl]-N-methylmethanamine
2.1.2 InChI
InChI=1S/C19H17F3N2O3S/c1-23-10-12-11-24(28(25,26)15-5-3-4-13(20)8-15)18(19(12)27-2)16-7-6-14(21)9-17(16)22/h3-9,11,23H,10H2,1-2H3
2.1.3 InChI Key
OUNXGNDVWVPCOL-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CNCC1=CN(C(=C1OC)C2=C(C=C(C=C2)F)F)S(=O)(=O)C3=CC=CC(=C3)F
2.2 Other Identifiers
2.2.1 UNII
BE52S2C1QT
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1h-pyrrole-3-methanamine, 5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-n-methyl-

2. 5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-n-methyl-1h-pyrrole-3-methanamine

3. Dwp-14012

4. Dwp14012

5. Fexuprazan

2.3.2 Depositor-Supplied Synonyms

1. Fexuprazan

2. 1902954-60-2

3. Dwp14012

4. Dwp-14012

5. Be52s2c1qt

6. 1-[5-(2,4-difluorophenyl)-1-(3-fluorobenzene-1-sulfonyl)-4-methoxy-1h-pyrrol-3-yl]-n-methylmethanamine

7. 1h-pyrrole-3-methanamine, 5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-n-methyl-

8. 5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-n-methyl-1h-pyrrole-3-methanamine

9. Abeprazan [inn]

10. Fexuprazan [inn]

11. Unii-be52s2c1qt

12. Chembl4594445

13. Schembl18196939

14. Glxc-25721

15. Hy-109079

16. Cs-0039254

17. 1-[5-(2,4-difluorophenyl)-1-(3-fluorophenyl)sulfonyl-4-methoxypyrrol-3-yl]-n-methylmethanamine

2.4 Create Date
2016-12-08
3 Chemical and Physical Properties
Molecular Weight 410.4 g/mol
Molecular Formula C19H17F3N2O3S
XLogP33.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count6
Exact Mass410.09119807 g/mol
Monoisotopic Mass410.09119807 g/mol
Topological Polar Surface Area68.7 Ų
Heavy Atom Count28
Formal Charge0
Complexity618
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Gastrointestinal Agents

Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)


API SUPPLIERS

read-more
read-more

01

Metrochem API Private Limited

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Metrochem

02

Shandong Chenghui Shuangda Pharmac...

China

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shandong Chenghui Shuangda Pharmaceutical

03

Neuland Laboratories

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Neuland

04

ChemExpress

China

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Company Banner

05

Equilife Impurities

India

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

FNCE
Not Confirmed
arrow

06

Daewoong Pharmaceutical

South Korea

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

FNCE
Not Confirmed
arrow

Daewoong Pharmaceutical

South Korea

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

arrow
FNCE
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down VMF Others AUDIT
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

KDMF

read-more
read-moreread-more

01

FNCE
Not Confirmed
arrow
arrow
FNCE
Not Confirmed

Pexuprazan hydrochloride

Registrant Name : Daewoong Bio Co., Ltd.

Registration Date : 2021-12-30

Registration Number : 1632-3-ND

Manufacturer Name : Daewoong Bio Co., Ltd.

Manufacturer Address : 29, Jaehakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

read-more
read-more

Details:

Fexuclue (fexuprazan HCl), a novel potassiumcompetitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Fexuclue

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Daewoong Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 07, 2025

blank

01

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : Fexuclue (fexuprazan HCl), a novel potassiumcompetitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades.

Product Name : Fexuclue

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 07, 2025

blank

Details:

DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Helicobacter Infections.


Lead Product(s): Fexuprazan,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: iNtherapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 27, 2024

blank

02

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Helicobacter Infections.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 27, 2024

blank

Details:

DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 18, 2024

blank

03

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 18, 2024

blank

Details:

Fexuprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Gastroesophageal Reflux.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 31, 2024

blank

04

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : Fexuprazan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Gastroesophageal Reflux.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 31, 2024

blank

Details:

DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Non-Erosive Reflux Disease.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 08, 2023

blank

05

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Non-Erosive Reflux Disease.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 08, 2023

blank

Details:

Under the agreement, Daewoong Pharmaceutical plans to expand its presence of a potassium-competitive acid blocker (P-CAB) drug Fexuclue (fexuprazan) in the African pharmaceutical market for gastroesophageal reflux disease (GERD).


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Fexuclue

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: COOPER PHARMA

Deal Size: $20.3 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 26, 2023

blank

06

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : Under the agreement, Daewoong Pharmaceutical plans to expand its presence of a potassium-competitive acid blocker (P-CAB) drug Fexuclue (fexuprazan) in the African pharmaceutical market for gastroesophageal reflux disease (GERD).

Product Name : Fexuclue

Product Type : Miscellaneous

Upfront Cash : Undisclosed

July 26, 2023

blank

Details:

Under the terms of the termination agreement, Daewoong regains all rights to the commercialization and clinical development of Fexuclue (fexuprazan), a novel potassium-competitive acid blocker for the treatment of erosive esophagitis, in the U.S. and Canada.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Fexuclue

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Neurogastrx

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination June 05, 2023

blank

07

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : Under the terms of the termination agreement, Daewoong regains all rights to the commercialization and clinical development of Fexuclue (fexuprazan), a novel potassium-competitive acid blocker for the treatment of erosive esophagitis, in the U.S. and Can...

Product Name : Fexuclue

Product Type : Miscellaneous

Upfront Cash : Undisclosed

June 05, 2023

blank

Details:

DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Esophagitis, Peptic.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 14, 2023

blank

08

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Esophagitis, Peptic.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 14, 2023

blank

Details:

DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Fexuprazan,DWC202201

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 13, 2023

blank

09

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : DWP14012 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 13, 2023

blank

Details:

Fexuclue (fexuprazan) is a potassium-competitive acid blocker (P-CAB) drug. By improving the drawbacks of existing proton pump inhibitors (PPIs), it binds to the proton pump without activating gastric acid and quickly and stably inhibits the secretion of gastric acid.


Lead Product(s): Fexuprazan,Inapplicable

Therapeutic Area: Gastroenterology Brand Name: Fexuclue

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 25, 2023

blank

10

FNCE
Not Confirmed
FNCE
Not Confirmed

Details : Fexuclue (fexuprazan) is a potassium-competitive acid blocker (P-CAB) drug. By improving the drawbacks of existing proton pump inhibitors (PPIs), it binds to the proton pump without activating gastric acid and quickly and stably inhibits the secretion of...

Product Name : Fexuclue

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 25, 2023

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATE SUPPLIERS

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 1902955-29-6

End Use API : Fexuprazan

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...

Shandong Chenghui Shuangda Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 701-27-9

End Use API : Fexuprazan

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...

Shandong Chenghui Shuangda Pharmaceutical

03

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 701-27-9

End Use API : Fexuprazan

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

04

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 2258638-53-6

End Use API : Fexuprazan

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

05

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 2258638-52-5

End Use API : Fexuprazan

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

06

FNCE
Not Confirmed
arrow
FNCE
Not Confirmed
arrow

CAS Number : 1902955-29-6

End Use API : Fexuprazan

About The Company : Equilife Laboratories Pvt. Ltd. is an India-based pharmaceutical company, specializing in innovative process development for pharmaceutical products and service...

blank

07

FNCE
Not Confirmed
arrow
FNCE
Not Confirmed
arrow

CAS Number : 1902955-29-6

End Use API : Fexuprazan

About The Company : Sunway Pharm ltd provides high quality building blocks to the global pharmaceutical and bio-technology industry. Combining our chemistry expertise and our econo...

blank

08

FNCE
Not Confirmed
arrow
FNCE
Not Confirmed
arrow

CAS Number : 701-27-9

End Use API : Fexuprazan

About The Company : We introduce ourselves as manufacturer of Active Pharmaceutical Ingredients (API) and intermediates with a professional approach that is aimed at finest results...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

NEWS #PharmaBuzz

read-more
read-more

ABOUT THIS PAGE

Looking for 1902954-60-2 / Fexuprazan API manufacturers, exporters & distributors?

Fexuprazan manufacturers, exporters & distributors 1

56

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

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

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

API | Excipient name

Fexuprazan

Synonyms

1902954-60-2, Dwp14012, Dwp-14012, Be52s2c1qt, 1-[5-(2,4-difluorophenyl)-1-(3-fluorobenzene-1-sulfonyl)-4-methoxy-1h-pyrrol-3-yl]-n-methylmethanamine, 1h-pyrrole-3-methanamine, 5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-n-methyl-

Cas Number

1902954-60-2

Unique Ingredient Identifier (UNII)

BE52S2C1QT

About Fexuprazan

Abeprazan is under investigation in clinical trial NCT04341454 (Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis).

Fexuprazan Manufacturers

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

Fexuprazan Suppliers

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

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

Fexuprazan KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Fexuprazan Drug Master File in Korea (Fexuprazan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fexuprazan. The MFDS reviews the Fexuprazan KDMF as part of the drug registration process and uses the information provided in the Fexuprazan KDMF to evaluate the safety and efficacy of the drug.

After submitting a Fexuprazan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fexuprazan API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Fexuprazan suppliers with KDMF on PharmaCompass.

Fexuprazan GMP

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

Fexuprazan CoA

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

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

Fexuprazan may be tested according to a variety of international standards, such as European Pharmacopoeia (Fexuprazan EP), Fexuprazan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fexuprazan 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty