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PharmaCompass offers a list of Ribavirin 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 Ribavirin manufacturer or Ribavirin supplier for your needs.
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A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide, including repackagers and relabelers. The FDA regulates 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide supplier is an individual or a company that provides 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide active pharmaceutical ingredient (API) or 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide finished formulations upon request. The 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide suppliers may include 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide API manufacturers, exporters, distributors and traders.
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A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide active pharmaceutical ingredient (API) in detail. Different forms of 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide DMFs exist exist since differing nations have different regulations, such as 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide DMF submitted to regulatory agencies in the US is known as a USDMF. 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide USDMF includes data on 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide Drug Master File in Japan (1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide JDMF) empowers 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide JDMF during the approval evaluation for pharmaceutical products. At the time of 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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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A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP of the European Pharmacopoeia monograph is often referred to as a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide Certificate of Suitability (COS). The purpose of a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide to their clients by showing that a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP has been issued for it. The manufacturer submits a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP holder for the record. Additionally, the data presented in the 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide DMF.
A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide written confirmation (1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide WC) is an official document issued by a regulatory agency to a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide manufacturer, verifying that the manufacturing facility of a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide APIs or 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide NDC to their finished compounded human drug products, they may choose to do so.
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1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide GMP manufacturer or 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide GMP API supplier for your needs.
A 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CoA (Certificate of Analysis) is a formal document that attests to 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide's compliance with 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide specifications and serves as a tool for batch-level quality control.
1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide CoA mostly includes findings from lab analyses of a specific batch. For each 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide 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.
1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide may be tested according to a variety of international standards, such as European Pharmacopoeia (1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide EP), 1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide USP).