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USDMF
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ABOUT THIS PAGE
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.
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.
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Vonoprazan Drug Master File in Korea (Vonoprazan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan. The MFDS reviews the Vonoprazan KDMF as part of the drug registration process and uses the information provided in the Vonoprazan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vonoprazan 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vonoprazan suppliers with KDMF on PharmaCompass.
A Vonoprazan written confirmation (Vonoprazan WC) is an official document issued by a regulatory agency to a Vonoprazan manufacturer, verifying that the manufacturing facility of a Vonoprazan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vonoprazan APIs or Vonoprazan finished pharmaceutical products to another nation, regulatory agencies frequently require a Vonoprazan WC (written confirmation) as part of the regulatory process.
click here to find a list of Vonoprazan 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vonoprazan 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vonoprazan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vonoprazan suppliers with NDC on PharmaCompass.
Vonoprazan 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 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 GMP manufacturer or Vonoprazan GMP API supplier for your needs.
A Vonoprazan CoA (Certificate of Analysis) is a formal document that attests to Vonoprazan's compliance with Vonoprazan specifications and serves as a tool for batch-level quality control.
Vonoprazan CoA mostly includes findings from lab analyses of a specific batch. For each Vonoprazan 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vonoprazan EP), Vonoprazan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vonoprazan USP).
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