Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 204655
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21153
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 21153
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
USFDA APPLICATION NUMBER - 21957
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22511
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22511
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier.
PharmaCompass also assists you with knowing the Esomeprazole Magnesium API Price utilized in the formulation of products. Esomeprazole Magnesium API Price is not always fixed or binding as the Esomeprazole Magnesium Price is obtained through a variety of data sources. The Esomeprazole Magnesium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A VIMOVO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of VIMOVO, including repackagers and relabelers. The FDA regulates VIMOVO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. VIMOVO 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 VIMOVO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A VIMOVO supplier is an individual or a company that provides VIMOVO active pharmaceutical ingredient (API) or VIMOVO finished formulations upon request. The VIMOVO suppliers may include VIMOVO API manufacturers, exporters, distributors and traders.
click here to find a list of VIMOVO suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A VIMOVO DMF (Drug Master File) is a document detailing the whole manufacturing process of VIMOVO active pharmaceutical ingredient (API) in detail. Different forms of VIMOVO DMFs exist exist since differing nations have different regulations, such as VIMOVO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A VIMOVO DMF submitted to regulatory agencies in the US is known as a USDMF. VIMOVO USDMF includes data on VIMOVO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The VIMOVO USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of VIMOVO suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The VIMOVO Drug Master File in Japan (VIMOVO JDMF) empowers VIMOVO API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the VIMOVO JDMF during the approval evaluation for pharmaceutical products. At the time of VIMOVO JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of VIMOVO suppliers with JDMF 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 VIMOVO Drug Master File in Korea (VIMOVO KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of VIMOVO. The MFDS reviews the VIMOVO KDMF as part of the drug registration process and uses the information provided in the VIMOVO KDMF to evaluate the safety and efficacy of the drug.
After submitting a VIMOVO 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 VIMOVO API can apply through the Korea Drug Master File (KDMF).
click here to find a list of VIMOVO suppliers with KDMF on PharmaCompass.
A VIMOVO CEP of the European Pharmacopoeia monograph is often referred to as a VIMOVO Certificate of Suitability (COS). The purpose of a VIMOVO CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of VIMOVO EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of VIMOVO to their clients by showing that a VIMOVO CEP has been issued for it. The manufacturer submits a VIMOVO CEP (COS) as part of the market authorization procedure, and it takes on the role of a VIMOVO CEP holder for the record. Additionally, the data presented in the VIMOVO CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the VIMOVO DMF.
A VIMOVO CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. VIMOVO CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of VIMOVO suppliers with CEP (COS) on PharmaCompass.
A VIMOVO written confirmation (VIMOVO WC) is an official document issued by a regulatory agency to a VIMOVO manufacturer, verifying that the manufacturing facility of a VIMOVO active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting VIMOVO APIs or VIMOVO finished pharmaceutical products to another nation, regulatory agencies frequently require a VIMOVO WC (written confirmation) as part of the regulatory process.
click here to find a list of VIMOVO 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 VIMOVO as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for VIMOVO 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 VIMOVO 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 VIMOVO and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a VIMOVO NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of VIMOVO suppliers with NDC on PharmaCompass.
VIMOVO 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 VIMOVO 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 VIMOVO GMP manufacturer or VIMOVO GMP API supplier for your needs.
A VIMOVO CoA (Certificate of Analysis) is a formal document that attests to VIMOVO's compliance with VIMOVO specifications and serves as a tool for batch-level quality control.
VIMOVO CoA mostly includes findings from lab analyses of a specific batch. For each VIMOVO 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.
VIMOVO may be tested according to a variety of international standards, such as European Pharmacopoeia (VIMOVO EP), VIMOVO JP (Japanese Pharmacopeia) and the US Pharmacopoeia (VIMOVO USP).
