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Country of origin : India

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The only EU CTD dossier on the platform

sofosbuvir + velpatasvir

Tablets 400 mg + 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #31580

Established in 1990, this Indian manufacturer employs approximately 3,065 individuals and specializes in developing and manufacturing IP-led niche finished dosage formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from major regulatory authorities, including the US FDA, EU-GMP, Health Canada, and UK MHRA, ensuring compliance with stringent international quality standards. The company operates eight manufacturing units across India, Singapore, Italy, the United States, and Kenya, producing a range of products, including soft gelatin capsules, tablets, and ointments. As a CTD dossier owner and manufacturer, its products are distributed in over 100 countries worldwide.

Manufacturer usually replies in 2 days

sofosbuvir + velpatasvir

Tablets 400 mg + 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Unavailable markets
Dominican Republic
Manufacturer #17753
This company is a global pharmaceutical manufacturer with decades of experience in the industry. They specialize in developing and manufacturing generic versions of complex and niche pharmaceutical products, with a focus on affordability and accessibility. Key areas of expertise include oncology, where they have achieved notable success in launching generic versions of blockbuster drugs. They also have a strong presence in the production of Rx products, OTC products, and APIs. Their product portfolio includes various dosage forms, including solids, injectables, and orals, all produced in facilities with EU and US GMP approvals. Their commitment to innovation and quality has led to the development of a robust R&D pipeline and a strong track record of successful product launches in key regions such as North America and the EU.

sofosbuvir + velpatasvir

Tablets 400 mg + 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #1509

Manufacturer usually replies in 26 days

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Sofosbuvir

Sofosbuvir is an antiviral medication that has direct acting-properties. It is prescribed as a part of combination therapy to treat chronic Hepatitis C. Hepatitis C is an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus with nine distinct genotypes. Its genotype 1 affects 72% of all chronic HCV patients in the USA. Treating chronic Hepatitis C have advanced significantly since 2011, with the introduction of Direct Acting Antivirals (DAAs) like Sofosbuvir. In a joint recommendation by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) in 2016 recommends Sofosbuvir as the first line therapy in combination with other antivirals for all six genotypes of Hepatitis C 14. Sofosbuvir is sold under the brand names Brands Hepcinat, Hepcvir, Resof, SoviHep amongst others. Michael Sofia at Pharmasset, sold to Gilead Sciences, discovered it in 2007 and was approved for use in the USA by the FDA in 2013 for the combination of sofosbuvir and ribavirin antiviral. Sofosbuvir’s Gilead products are Sovaldi and Harvoni.

Dosage and Administration

Sofosbuvir is sold as a 400mg tablet. In the treatment of Hepatitis C Virus (HCV) Infection, in combination antiviral regimen for HCV mono-infection and HCV/HIV-1 coinfection, the regime and duration are decided on genotype and patient population. In treating infection related to Genotype 1 or 4, the dose is 400 mg a day given with Ribavirin and peginterferon alfa for 3 months or 12 weeks. Sofosbuvir with ribavirin is prescribed for 24 weeks in genotype 1 patients who are ineligible to receive a peg-interferon-based regimen. Hepatocellular carcinoma patients who are awaiting liver transplantation, are given these medicines for prevention and reinfection post-transplant. The dose is set at 400 mg with ribavirin until the time of liver transplantation or for up to 48 weeks or, whichever comes first. There are several other combinations with other medicines targeted at specific genotypes, so consult with the doctor to choose the specific combination and dosage.

The price of Sofosbuvir

In the USA, the consumers pay a wholesale acquisition cost of USD 1000 for each 400 mg pill, totaling a total of USD 84,000 for 12- week treatment. The same medicine is made by generic drug makers in countries like India, where the same 400 mg pill costs only USD4, USD350-400.

How does it work?

Sofosbuvir is a nucleotide analog inhibitor. It targets HCV NS5B RNA-dependent RNA polymerase specifically for inhibition. After intracellular metabolism, it converts to active uridine analog triphosphate. Sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator Synthesis resulting in the prevention of HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif. This prevents further replication of HCV genetic material. Sofosbuvir actions inhibit the reproduction of genetic material of the hepatitis C virus, through inhibition of an RNA-dependent polymerase needed by the virus to replicate itself.

Finding Sofosbuvir Manufacturers and Suppliers

The best way to find and gain access to Sofosbuvir manufacturers and Sofosbuvir suppliers is to make through Pipelinepharma's global B2B online marketplace for medicines and other pharmaceuticals. Normally, finding trusted manufacturers and supplies of specific drugs like Sofosbuvir can be a time- consuming challenge, but with Pipelinepharma's simple search engine and network of proven partners, the whole process becomes a lot easier. All you need to do to get started is to make use of our integrated search engine and start looking for suppliers or manufacturers of Sofosbuvir to work with. You can fine-tune your search results using various filters too, letting you search for Sofosbuvir from specific countries.

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