Synopsis
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CEP/COS
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JDMF
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VMF
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Europe
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Canada
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Australia
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South Africa
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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
BR
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Neuland Laboratories- A dedicated 100% API provider.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Evonik Health Care is the innovation hub for leading life science companies
With Virupaksha, you get a quality product with on-time delivery.
AMI Lifesciences is Driven by Chemistry. Powered by People.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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USDMF
Metrochem 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 :
Type : II
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40356
Submission : 2024-12-29
Status :
Type : II
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39107
Submission : 2023-11-02
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42655
Submission : 2025-09-26
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39528
Submission : 2024-02-29
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36262
Submission : 2021-09-06
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40334
Submission : 2025-01-08
Status :
Type : II
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38293
Submission : 2023-04-17
Status :
Type : II
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic Development Zone, Sh...
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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.
A Vonoprazan monofumurate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan monofumurate, including repackagers and relabelers. The FDA regulates Vonoprazan monofumurate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan monofumurate 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 monofumurate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan monofumurate supplier is an individual or a company that provides Vonoprazan monofumurate active pharmaceutical ingredient (API) or Vonoprazan monofumurate finished formulations upon request. The Vonoprazan monofumurate suppliers may include Vonoprazan monofumurate API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan monofumurate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vonoprazan monofumurate DMF (Drug Master File) is a document detailing the whole manufacturing process of Vonoprazan monofumurate active pharmaceutical ingredient (API) in detail. Different forms of Vonoprazan monofumurate DMFs exist exist since differing nations have different regulations, such as Vonoprazan monofumurate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vonoprazan monofumurate DMF submitted to regulatory agencies in the US is known as a USDMF. Vonoprazan monofumurate USDMF includes data on Vonoprazan monofumurate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vonoprazan monofumurate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vonoprazan monofumurate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Vonoprazan monofumurate Drug Master File in Korea (Vonoprazan monofumurate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan monofumurate. The MFDS reviews the Vonoprazan monofumurate KDMF as part of the drug registration process and uses the information provided in the Vonoprazan monofumurate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vonoprazan monofumurate 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 Vonoprazan monofumurate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vonoprazan monofumurate suppliers with KDMF on PharmaCompass.
A Vonoprazan monofumurate written confirmation (Vonoprazan monofumurate WC) is an official document issued by a regulatory agency to a Vonoprazan monofumurate manufacturer, verifying that the manufacturing facility of a Vonoprazan monofumurate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan monofumurate APIs or Vonoprazan monofumurate finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan monofumurate WC (written confirmation) as part of the regulatory process.
click here to find a list of Vonoprazan monofumurate suppliers with Written Confirmation (WC) on PharmaCompass.
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 Vonoprazan monofumurate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vonoprazan monofumurate API and other APIs are published in this directory by the FDA.
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 Vonoprazan monofumurate 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.
The NDC directory also contains data on finished compounded human drug products that contain Vonoprazan monofumurate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vonoprazan monofumurate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vonoprazan monofumurate suppliers with NDC on PharmaCompass.
Vonoprazan monofumurate 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 Vonoprazan monofumurate 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 Vonoprazan monofumurate GMP manufacturer or Vonoprazan monofumurate GMP API supplier for your needs.
A Vonoprazan monofumurate CoA (Certificate of Analysis) is a formal document that attests to Vonoprazan monofumurate's compliance with Vonoprazan monofumurate specifications and serves as a tool for batch-level quality control.
Vonoprazan monofumurate CoA mostly includes findings from lab analyses of a specific batch. For each Vonoprazan monofumurate 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.
Vonoprazan monofumurate may be tested according to a variety of international standards, such as European Pharmacopoeia (Vonoprazan monofumurate EP), Vonoprazan monofumurate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vonoprazan monofumurate USP).
