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CEP/COS
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VMF
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Europe
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Stock Recap #PipelineProspector
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API SUPPLIERS
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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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.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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
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 :
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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
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
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
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43756
Submission : 2026-03-23
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
A 1260141-27-2 (fumarate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1260141-27-2 (fumarate), including repackagers and relabelers. The FDA regulates 1260141-27-2 (fumarate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 1260141-27-2 (fumarate) supplier is an individual or a company that provides 1260141-27-2 (fumarate) active pharmaceutical ingredient (API) or 1260141-27-2 (fumarate) finished formulations upon request. The 1260141-27-2 (fumarate) suppliers may include 1260141-27-2 (fumarate) API manufacturers, exporters, distributors and traders.
click here to find a list of 1260141-27-2 (fumarate) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 1260141-27-2 (fumarate) DMF (Drug Master File) is a document detailing the whole manufacturing process of 1260141-27-2 (fumarate) active pharmaceutical ingredient (API) in detail. Different forms of 1260141-27-2 (fumarate) DMFs exist exist since differing nations have different regulations, such as 1260141-27-2 (fumarate) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1260141-27-2 (fumarate) DMF submitted to regulatory agencies in the US is known as a USDMF. 1260141-27-2 (fumarate) USDMF includes data on 1260141-27-2 (fumarate)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1260141-27-2 (fumarate) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) Drug Master File in Korea (1260141-27-2 (fumarate) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1260141-27-2 (fumarate). The MFDS reviews the 1260141-27-2 (fumarate) KDMF as part of the drug registration process and uses the information provided in the 1260141-27-2 (fumarate) KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1260141-27-2 (fumarate) suppliers with KDMF on PharmaCompass.
A 1260141-27-2 (fumarate) written confirmation (1260141-27-2 (fumarate) WC) is an official document issued by a regulatory agency to a 1260141-27-2 (fumarate) manufacturer, verifying that the manufacturing facility of a 1260141-27-2 (fumarate) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1260141-27-2 (fumarate) APIs or 1260141-27-2 (fumarate) finished pharmaceutical products to another nation, regulatory agencies frequently require a 1260141-27-2 (fumarate) WC (written confirmation) as part of the regulatory process.
click here to find a list of 1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1260141-27-2 (fumarate) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 1260141-27-2 (fumarate) suppliers with NDC on PharmaCompass.
1260141-27-2 (fumarate) 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 1260141-27-2 (fumarate) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 1260141-27-2 (fumarate) GMP manufacturer or 1260141-27-2 (fumarate) GMP API supplier for your needs.
A 1260141-27-2 (fumarate) CoA (Certificate of Analysis) is a formal document that attests to 1260141-27-2 (fumarate)'s compliance with 1260141-27-2 (fumarate) specifications and serves as a tool for batch-level quality control.
1260141-27-2 (fumarate) CoA mostly includes findings from lab analyses of a specific batch. For each 1260141-27-2 (fumarate) 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.
1260141-27-2 (fumarate) may be tested according to a variety of international standards, such as European Pharmacopoeia (1260141-27-2 (fumarate) EP), 1260141-27-2 (fumarate) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1260141-27-2 (fumarate) USP).
