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ledipasvir + sofosbuvir

Tablets 90 mg + 400 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
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.

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Ledipasvir

Ledipasvir is a medication used in the treatment of hepatitis C. The Ledipasvir/sofosbuvir combination is a direct-acting antiviral agent, which directly interferes with virus replication and can also treat other types of patients with different genotypes. Ledipasvir is an inhibitor of NS5A, a Virus protein causing hepatitis C. Ledipasvir drug has effective in treatment- naive and treatment experienced patients. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommended Ledipasvir as a first line therapy in combination with sofosbuvir in the treatment of various HCV genotypes. Gilead Sciences developed Ledipasvir. After completing Phase III clinical trials in 2014 Gilead filed for U.S. approval of a Ledipasvir/sofosbuvir fixed-dose combination tablet for genotype 1 hepatitis C and got the FDA approval for the combination product Ledipasvir/sofosbuvir called Harvoni.

Forms and Dosage

Ledipasvir and sofosbuvir is sold as pellets and is swallowed without chewing or they can be mixed with food. The dose is prepared by sprinkling the pellets on one or more spoonfuls of cold non-acidic food like pudding or ice cream. The patient then has to take the mixture within 30 minutes of sprinkling the pellets. It is recommended to continue with Ledipasvir and sofosbuvir even the patient feels wells as the course last from 8 to 24 weeks depending on patients and how well they responds to the medication.

The cost of Ledipasvir

In the USA, a consumer has to pay the wholesale price for Ledipasvir-sofosbuvir at $1125 per pill. The cost of a 8 week therapy is $63,000, 12 week therapy costs $95,000 and the Cost of 24-week course of therapy is $189,000.

How does Ledipasvir work?

Ledipasvir inhibits an important a type of viral phosphoprotein, NS5A, this phosphoprotein is essential for viral replication, assembly, and secretion. When taken, Ledipasvir binds to and blocks the activity of the viral phosphoprotein resulting in the disruption of the viral production, and inhibition of viral replication.

Finding Ledipasvir Manufacturers and Ledipasvir Suppliers

One of the fastest and easiest ways to find Ledipasvir manufacturers and Ledipasvir suppliers is to make use of Pipelinepharma's global B2B online marketplace for medicines and other pharmaceuticals. Usually, finding trusted manufacturers and supplies of specific drugs like Ledipasvir 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 make use of our integrated search engine and start looking for suppliers or manufacturers of Ledipasvir to work with. You can fine-tune your search results using various filters too, letting you search for Ledipasvir from specific countries, for example.

Manufacturers in India

Tecoland Corporation, Century Pharmaceuticals, Aspire Lifesciences Pvt Ltd, Deafarma, Hetero Drugs Limited

In China

Hanways Chempharm Co., Limited , o Haoyuan Chemexpress Co.Ltd rporation https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ledipasvir https://www.drugbank.ca/drugs/DB09027 https://en.wikipedia.org/wiki/Ledipasvir https://pubchem.ncbi.nlm.nih.gov/compound/Ledipasvir https://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir https://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir https://medlineplus.gov/druginfo/meds/a614051.html https://www.webmd.com/drugs/2/drug-167104/ledipasvir-sofosbuvir-oral/details https://www.journal-of-hepatology.eu/article/S0168-8278(18)30874-2/abstract https://www.who.int/docs/default-source/essential-medicines/intellectual-property/ledipasvir- report.pdf?sfvrsn=63bba21b_2

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