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01 1Metrochem API Private Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35150

Submission : 2020-08-31

Status : Active

Type : II

Metrochem

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.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39107

Submission : 2023-11-02

Status : Active

Type : II

Shandong Chenghui Shuangda Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

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DMF Number : 39528

Submission : 2024-02-29

Status : Active

Type : II

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04

Pharmagora Plus 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

GDUFA

DMF Review : N/A

Rev. Date :

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DMF Number : 36262

Submission : 2021-09-06

Status : Active

Type : II

AMI Lifesciences

05

Pharmagora Plus 2025
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40682

Submission : 2024-10-14

Status : Active

Type : II

Porton Company Banner

06

Pharmagora Plus 2025
Not Confirmed

07

Pharmagora Plus 2025
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Looking for 1260141-27-2 / Vonoprazan Fumarate API manufacturers, exporters & distributors?

Vonoprazan Fumarate manufacturers, exporters & distributors 1

71

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

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

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

API | Excipient name

Vonoprazan Fumarate

Synonyms

Tak-438, 1260141-27-2, 881681-01-2, Vonoprazan fumurate, 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine fumarate, Tak 438

Cas Number

1260141-27-2

Unique Ingredient Identifier (UNII)

4QW3X4AMLB

About Vonoprazan Fumarate

Vonoprazan Fumarate is the fumarate salt form of vonoprazan, a pyrrole derivative and reversible potassium-competitive acid blocker (P-CAB), with potential antacid activity. Upon administration, vonoprazan specifically and competitively binds to the gastric hydrogen-potassium ATPase (H+/K+ ATPase) proton pump at or, more likely, near its potassium ion (K+) binding site and sterically inhibits K+ binding. This blocks the activation of the H+/K+ ATPase by K+, inhibits the proton pump and prevents gastric acid secretion, thereby lowering gastric acid levels.

Vonoprazan Manufacturers

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

Vonoprazan Suppliers

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

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

Vonoprazan USDMF

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

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

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

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.