Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Velpatasvir API for pharmaceutical formulation, development, research and regulated pharmaceutical manufacturing applications.
Velpatasvir is a synthetic small-molecule hepatitis C virus (HCV) NS5A inhibitor used as an active pharmaceutical ingredient in antiviral formulations. It is primarily used in combination with other direct-acting antiviral agents, including sofosbuvir, for the treatment of chronic hepatitis C virus infection.
Velpatasvir is identified by CAS No. 1377049-84-7, with molecular formula C49H54N8O8 and molecular weight approximately 883.0 g/mol.
Velpatasvir is a complex synthetic antiviral molecule belonging to the class of HCV NS5A inhibitors. It is designed to interfere with the HCV NS5A protein, an essential component of the viral replication process.
Velpatasvir is commercially important as an API for direct-acting antiviral pharmaceutical formulations. FDA-approved pharmaceutical products contain velpatasvir in combination with other antiviral active ingredients for the treatment of chronic HCV infection.
FDA information describes Velpatasvir as practically insoluble at higher pH, slightly soluble at pH 2 and substantially more soluble at pH 1.2.
Velpatasvir API is primarily used in pharmaceutical development and manufacturing of direct-acting antiviral formulations for chronic hepatitis C virus infection.
Key applications include:
Velpatasvir is used in combination antiviral therapy and is an important component of modern pan-genotypic HCV treatment formulations. FDA records identify sofosbuvir/velpatasvir products for chronic HCV infection involving genotypes 1 through 6 under the applicable approved indications.
Velpatasvir requires appropriate controls for identity, assay, related substances, residual solvents and elemental impurities as part of pharmaceutical API quality management.
FDA chemistry documentation confirms that Velpatasvir drug-substance specifications include controls for critical quality attributes and specifically evaluates organic impurities in the drug substance.
For pharmaceutical manufacturing, Velpatasvir API should therefore be evaluated using validated analytical methods appropriate to the drug substance and the intended regulatory market.
Swapnroop Drugs & Pharmaceuticals provides Velpatasvir API manufacturing and supply support for pharmaceutical companies, formulation developers and customers involved in antiviral pharmaceutical development and manufacturing.
As a Velpatasvir API manufacturer and supplier in India, Swapnroop supports requirements involving:
Velpatasvir API should be stored in suitable tightly closed pharmaceutical-grade containers under controlled environmental conditions.
The material should be protected from excessive moisture, heat, light and unsuitable environmental exposure. Storage conditions should follow the applicable product specification, safety documentation and validated stability requirements.
Typical pharmaceutical documentation may include:
Quality control for Velpatasvir API may include analytical evaluation of identity, assay, related substances, residual solvents and elemental impurities.
FDA chemistry documentation confirms that Velpatasvir drug substance quality specifications include controls for appearance, identity, assay, related substances, residual solvents and elemental impurities.
Because Velpatasvir is a complex small molecule with multiple stereochemical centers and numerous related-substance considerations, validated chromatographic methods and appropriate impurity controls are important for pharmaceutical-grade material.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and qualified customers seeking Velpatasvir API for formulation, development and regulated pharmaceutical manufacturing applications.
Our approach focuses on:
Swapnroop supports customers looking for Velpatasvir API Manufacturer and Supplier in India for antiviral pharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0–102.0% on anhydrous basis |
| Residue on Ignition | NMT 0.20% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.30% |
| Total Impurities | NMT 1.00% |
| Water Content | NMT 5.0% |
| Melting Point | 170–190°C |
| Solubility | Soluble in methanol and acetonitrile; slightly soluble in isopropyl alcohol and 0.1 N HCl; practically insoluble in water |