Hepatitis C virus (HCV) infection remains a significant global health challenge, but the advent of Direct-Acting Antivirals (DAAs) has revolutionized its treatment. Among these, Sofosbuvir stands out as a cornerstone therapy, primarily used as a key active pharmaceutical ingredient (API) in various highly effective combination regimens.
Sofosbuvir powder, with its high purity typically exceeding 99% as confirmed by HPLC, serves as the foundational raw material for these life-saving medications. It is a white crystalline powder identified by CAS number 1190307-88-0, molecular formula C22H29FN3O9P, and molecular weight 529.45 g/mol. As a uridine nucleotide analog prodrug, its unique chemical structure includes a phosphoramidate moiety, designed for efficient delivery specifically to the liver, the primary site of HCV replication. Once inside liver cells, Sofosbuvir is metabolized into its active triphosphate form, GS-461203.
The therapeutic power of Sofosbuvir lies in its potent and selective inhibition of the HCV NS5B RNA-dependent RNA polymerase. This enzyme is essential for the virus to replicate its genetic material. By acting as a chain terminator during viral RNA synthesis, Sofosbuvir effectively halts the replication process. This mechanism provides several critical advantages, including pan-genotypic efficacy, meaning it is effective against all known HCV genotypes (1 through 6). Furthermore, it demonstrates a high barrier to resistance, a crucial factor in preventing treatment failure and relapse, attributed to targeting a highly conserved region of the NS5B polymerase.
Clinical trials have consistently shown that Sofosbuvir-based combination therapies, often administered as a simple once-daily oral dose, achieve sustained virologic response (SVR) rates of over 90% after typically 12 weeks of treatment. This remarkable success has transformed chronic Hepatitis C from a debilitating, progressive disease into a curable condition for the vast majority of patients, dramatically reducing the incidence of liver cirrhosis, hepatocellular carcinoma, and liver transplantation.
Ensuring the supply of high-quality Sofosbuvir API is paramount for pharmaceutical companies manufacturing these treatments. Pharmaceutical grade Sofosbuvir must meet stringent quality standards, including specific purity levels, control of impurities, and physical characteristics. Certifications such as GMP (Good Manufacturing Practice), ISO 9001, USP (United States Pharmacopeia), and BP (British Pharmacopoeia) are often required to guarantee the material's suitability for pharmaceutical use. Advanced analytical methods like HPLC are routinely employed for assay and purity testing.
For pharmaceutical formulators and drug manufacturers, finding a reliable source for high-quality Sofosbuvir powder is critical. NINGBO INNO PHARMCHEM CO.,LTD. specializes in providing pharmaceutical raw materials, including high-purity Sofosbuvir API. Companies seeking to purchase or inquire about Sofosbuvir API price can contact trusted providers. Researching different options for a sofosbuvir powder supplier or sofosbuvir API manufacturer is an essential step in securing the necessary materials for production. Whether you are looking to buy sofosbuvir in bulk or discuss specific requirements for a sofosbuvir purchase, partnering with an experienced supplier is key to maintaining the quality and efficacy of the final drug product.
Manufacturing Facilities
Professional Export Experience
to Global Customers
1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;
2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;
3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).
A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.
A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.
A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.