Synopsis
Synopsis
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EU WC
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EDQM
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JP
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Molecular Weight | 1711.0 g/mol |
---|---|
Molecular Formula | C78H139N11O30 |
XLogP3 | -5.9 |
Hydrogen Bond Donor Count | 20 |
Hydrogen Bond Acceptor Count | 30 |
Rotatable Bond Count | 63 |
Exact Mass | 1709.9689321 g/mol |
Monoisotopic Mass | 1709.9689321 g/mol |
Topological Polar Surface Area | 597 Ų |
Heavy Atom Count | 119 |
Formal Charge | 0 |
Complexity | 2730 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 17 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.
NDC Package Code : 70596-1001
Start Marketing Date : 2019-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.
About the Company : Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuz...
About the Company : Sinopep leads the industry in therapeutic peptides, supplying top-demand APIs like Albuvirtide, Lanreotide, Semaglutide, and more. Renowned for high-quality peptide APIs and effici...
Details:
SAR-439774 (fitusiran) is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors.
Lead Product(s): Fitusiran
Therapeutic Area: Genetic Disease Brand Name: SAR439774
Study Phase: Phase IIIProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 04, 2023
Lead Product(s) : Fitusiran
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SAR-439774 (fitusiran) is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors.
Product Name : SAR439774
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
April 04, 2023
Details:
SAR-439774 (fitusiran) is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors.
Lead Product(s): Fitusiran
Therapeutic Area: Genetic Disease Brand Name: SAR439774
Study Phase: Phase IIIProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 07, 2022
Lead Product(s) : Fitusiran
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SAR-439774 (fitusiran) is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors.
Product Name : SAR439774
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
October 07, 2022
Details:
Qfitlia (fitusiran) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B.
Lead Product(s): Fitusiran
Therapeutic Area: Genetic Disease Brand Name: Qfitlia
Study Phase: Approved FDFProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2025
Lead Product(s) : Fitusiran
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Qfitlia (fitusiran), First siRNA for Hemophilia A or B Treatment
Details : Qfitlia (fitusiran) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B.
Product Name : Qfitlia
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
March 28, 2025
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PharmaCompass offers a list of Givosiran 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 Givosiran manufacturer or Givosiran supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Givosiran manufacturer or Givosiran supplier.
PharmaCompass also assists you with knowing the Givosiran API Price utilized in the formulation of products. Givosiran API Price is not always fixed or binding as the Givosiran Price is obtained through a variety of data sources. The Givosiran Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fitusiran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fitusiran, including repackagers and relabelers. The FDA regulates Fitusiran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fitusiran 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 Fitusiran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fitusiran supplier is an individual or a company that provides Fitusiran active pharmaceutical ingredient (API) or Fitusiran finished formulations upon request. The Fitusiran suppliers may include Fitusiran API manufacturers, exporters, distributors and traders.
click here to find a list of Fitusiran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Fitusiran as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fitusiran 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 Fitusiran 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 Fitusiran and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fitusiran NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fitusiran suppliers with NDC on PharmaCompass.
Fitusiran 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 Fitusiran 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 Fitusiran GMP manufacturer or Fitusiran GMP API supplier for your needs.
A Fitusiran CoA (Certificate of Analysis) is a formal document that attests to Fitusiran's compliance with Fitusiran specifications and serves as a tool for batch-level quality control.
Fitusiran CoA mostly includes findings from lab analyses of a specific batch. For each Fitusiran 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.
Fitusiran may be tested according to a variety of international standards, such as European Pharmacopoeia (Fitusiran EP), Fitusiran JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fitusiran USP).