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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.
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
EU-WC
Neuland Laboratories- A dedicated 100% API provider.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
With Virupaksha, you get a quality product with on-time delivery.
AMI Lifesciences is Driven by Chemistry. Powered by People.
EU-WC
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Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
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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
China'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 :
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
Porton 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 :
Type : II
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ABOUT THIS PAGE
A Vonoprazan fumarate (JAN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan fumarate (JAN), including repackagers and relabelers. The FDA regulates Vonoprazan fumarate (JAN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan fumarate (JAN) 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 fumarate (JAN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan fumarate (JAN) supplier is an individual or a company that provides Vonoprazan fumarate (JAN) active pharmaceutical ingredient (API) or Vonoprazan fumarate (JAN) finished formulations upon request. The Vonoprazan fumarate (JAN) suppliers may include Vonoprazan fumarate (JAN) API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan fumarate (JAN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vonoprazan fumarate (JAN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Vonoprazan fumarate (JAN) active pharmaceutical ingredient (API) in detail. Different forms of Vonoprazan fumarate (JAN) DMFs exist exist since differing nations have different regulations, such as Vonoprazan fumarate (JAN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vonoprazan fumarate (JAN) DMF submitted to regulatory agencies in the US is known as a USDMF. Vonoprazan fumarate (JAN) USDMF includes data on Vonoprazan fumarate (JAN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vonoprazan fumarate (JAN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vonoprazan fumarate (JAN) 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 fumarate (JAN) Drug Master File in Korea (Vonoprazan fumarate (JAN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan fumarate (JAN). The MFDS reviews the Vonoprazan fumarate (JAN) KDMF as part of the drug registration process and uses the information provided in the Vonoprazan fumarate (JAN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vonoprazan fumarate (JAN) 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 fumarate (JAN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vonoprazan fumarate (JAN) suppliers with KDMF on PharmaCompass.
A Vonoprazan fumarate (JAN) written confirmation (Vonoprazan fumarate (JAN) WC) is an official document issued by a regulatory agency to a Vonoprazan fumarate (JAN) manufacturer, verifying that the manufacturing facility of a Vonoprazan fumarate (JAN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan fumarate (JAN) APIs or Vonoprazan fumarate (JAN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan fumarate (JAN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Vonoprazan fumarate (JAN) 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 fumarate (JAN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vonoprazan fumarate (JAN) 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 fumarate (JAN) 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 fumarate (JAN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vonoprazan fumarate (JAN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vonoprazan fumarate (JAN) suppliers with NDC on PharmaCompass.
Vonoprazan fumarate (JAN) 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 fumarate (JAN) 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 fumarate (JAN) GMP manufacturer or Vonoprazan fumarate (JAN) GMP API supplier for your needs.
A Vonoprazan fumarate (JAN) CoA (Certificate of Analysis) is a formal document that attests to Vonoprazan fumarate (JAN)'s compliance with Vonoprazan fumarate (JAN) specifications and serves as a tool for batch-level quality control.
Vonoprazan fumarate (JAN) CoA mostly includes findings from lab analyses of a specific batch. For each Vonoprazan fumarate (JAN) 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 fumarate (JAN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Vonoprazan fumarate (JAN) EP), Vonoprazan fumarate (JAN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vonoprazan fumarate (JAN) USP).
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