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API SUPPLIERS
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USDMF
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Riociguat 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 Riociguat manufacturer or Riociguat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Riociguat manufacturer or Riociguat supplier.
PharmaCompass also assists you with knowing the Riociguat API Price utilized in the formulation of products. Riociguat API Price is not always fixed or binding as the Riociguat Price is obtained through a variety of data sources. The Riociguat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Riociguat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riociguat, including repackagers and relabelers. The FDA regulates Riociguat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riociguat 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 Riociguat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riociguat supplier is an individual or a company that provides Riociguat active pharmaceutical ingredient (API) or Riociguat finished formulations upon request. The Riociguat suppliers may include Riociguat API manufacturers, exporters, distributors and traders.
click here to find a list of Riociguat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Riociguat DMF (Drug Master File) is a document detailing the whole manufacturing process of Riociguat active pharmaceutical ingredient (API) in detail. Different forms of Riociguat DMFs exist exist since differing nations have different regulations, such as Riociguat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riociguat DMF submitted to regulatory agencies in the US is known as a USDMF. Riociguat USDMF includes data on Riociguat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riociguat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riociguat suppliers with USDMF on PharmaCompass.
A Riociguat CEP of the European Pharmacopoeia monograph is often referred to as a Riociguat Certificate of Suitability (COS). The purpose of a Riociguat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Riociguat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Riociguat to their clients by showing that a Riociguat CEP has been issued for it. The manufacturer submits a Riociguat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Riociguat CEP holder for the record. Additionally, the data presented in the Riociguat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Riociguat DMF.
A Riociguat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Riociguat 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 Riociguat suppliers with CEP (COS) on PharmaCompass.
A Riociguat written confirmation (Riociguat WC) is an official document issued by a regulatory agency to a Riociguat manufacturer, verifying that the manufacturing facility of a Riociguat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Riociguat APIs or Riociguat finished pharmaceutical products to another nation, regulatory agencies frequently require a Riociguat WC (written confirmation) as part of the regulatory process.
click here to find a list of Riociguat 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 Riociguat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Riociguat 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 Riociguat 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 Riociguat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Riociguat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Riociguat suppliers with NDC on PharmaCompass.
Riociguat 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 Riociguat 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 Riociguat GMP manufacturer or Riociguat GMP API supplier for your needs.
A Riociguat CoA (Certificate of Analysis) is a formal document that attests to Riociguat's compliance with Riociguat specifications and serves as a tool for batch-level quality control.
Riociguat CoA mostly includes findings from lab analyses of a specific batch. For each Riociguat 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.
Riociguat may be tested according to a variety of international standards, such as European Pharmacopoeia (Riociguat EP), Riociguat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Riociguat USP).
