How to Source Sofosbuvir & Ledipasvir Tablets for Pharmaceutical Formulation

Sofosbuvir & Ledipasvir Tablets (Tablet, 90 mg Ledipasvir / 400 mg Sofosbuvir) is classified under Hepatitis. It is therapeutically aligned with reference brands such as Harvoni® (EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Sofosbuvir & Ledipasvir Tablets for formulation, R&D, or bulk manufacturing.

Product Overview: Sofosbuvir & Ledipasvir Tablets (Harvoni®) are a once-daily oral treatment for chronic Hepatitis C infection. Combining 400 mg Sofosbuvir and 90 mg Ledipasvir, this FDA- and EMA-approved antiviral effectively stops viral replication. Widely used in the US and EU, it offers a safe, well-tolerated cure, making it essential for pharma B2B suppliers and healthcare providers targeting Hepatitis C management. Sofosbuvir & Ledipasvir Tablets are a fixed-dose oral antiviral combination used to treat chronic He...

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Sofosbuvir & Ledipasvir Tablets must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Sofosbuvir & Ledipasvir Tablets is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Sofosbuvir & Ledipasvir Tablets is more than procurement—it’s a strategic partnership. With its tablet form and 90 mg Ledipasvir / 400 mg Sofosbuvir specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Sofosbuvir & Ledipasvir Tablets