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PharmaCompass offers a list of Rabeprazole 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 Rabeprazole manufacturer or Rabeprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rabeprazole manufacturer or Rabeprazole supplier.
PharmaCompass also assists you with knowing the Rabeprazole API Price utilized in the formulation of products. Rabeprazole API Price is not always fixed or binding as the Rabeprazole Price is obtained through a variety of data sources. The Rabeprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexrabeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexrabeprazole Sodium, including repackagers and relabelers. The FDA regulates Dexrabeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexrabeprazole Sodium 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 Dexrabeprazole Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexrabeprazole Sodium supplier is an individual or a company that provides Dexrabeprazole Sodium active pharmaceutical ingredient (API) or Dexrabeprazole Sodium finished formulations upon request. The Dexrabeprazole Sodium suppliers may include Dexrabeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Dexrabeprazole Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexrabeprazole Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexrabeprazole Sodium active pharmaceutical ingredient (API) in detail. Different forms of Dexrabeprazole Sodium DMFs exist exist since differing nations have different regulations, such as Dexrabeprazole Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexrabeprazole Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Dexrabeprazole Sodium USDMF includes data on Dexrabeprazole Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexrabeprazole Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Dexrabeprazole Sodium Drug Master File in Japan (Dexrabeprazole Sodium JDMF) empowers Dexrabeprazole Sodium 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 Dexrabeprazole Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Dexrabeprazole Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dexrabeprazole Sodium Drug Master File in Korea (Dexrabeprazole Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexrabeprazole Sodium. The MFDS reviews the Dexrabeprazole Sodium KDMF as part of the drug registration process and uses the information provided in the Dexrabeprazole Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexrabeprazole Sodium 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 Dexrabeprazole Sodium API can apply through the Korea Drug Master File (KDMF).
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A Dexrabeprazole Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Dexrabeprazole Sodium Certificate of Suitability (COS). The purpose of a Dexrabeprazole Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexrabeprazole Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexrabeprazole Sodium to their clients by showing that a Dexrabeprazole Sodium CEP has been issued for it. The manufacturer submits a Dexrabeprazole Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexrabeprazole Sodium CEP holder for the record. Additionally, the data presented in the Dexrabeprazole Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexrabeprazole Sodium DMF.
A Dexrabeprazole Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexrabeprazole Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Dexrabeprazole Sodium written confirmation (Dexrabeprazole Sodium WC) is an official document issued by a regulatory agency to a Dexrabeprazole Sodium manufacturer, verifying that the manufacturing facility of a Dexrabeprazole Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexrabeprazole Sodium APIs or Dexrabeprazole Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexrabeprazole Sodium WC (written confirmation) as part of the regulatory process.
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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 Dexrabeprazole Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexrabeprazole Sodium 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 Dexrabeprazole Sodium 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 Dexrabeprazole Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexrabeprazole Sodium NDC to their finished compounded human drug products, they may choose to do so.
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Dexrabeprazole Sodium 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 Dexrabeprazole Sodium 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 Dexrabeprazole Sodium GMP manufacturer or Dexrabeprazole Sodium GMP API supplier for your needs.
A Dexrabeprazole Sodium CoA (Certificate of Analysis) is a formal document that attests to Dexrabeprazole Sodium's compliance with Dexrabeprazole Sodium specifications and serves as a tool for batch-level quality control.
Dexrabeprazole Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Dexrabeprazole Sodium 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.
Dexrabeprazole Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexrabeprazole Sodium EP), Dexrabeprazole Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexrabeprazole Sodium USP).