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