How to Source Treprostinil IV for Pharmaceutical Formulation

Treprostinil IV (SC or Intravenous (IV), 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL)) is classified under Orphan Drugs. It is therapeutically aligned with reference brands such as Remodulin(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Treprostinil IV for formulation, R&D, or bulk manufacturing.

Product Overview: Treprostinil, administered via subcutaneous or intravenous infusion, is a prostacyclin analogue that dilates pulmonary blood vessels and inhibits platelet aggregation. It improves exercise capacity, reduces PAH symptoms, and enhances quality of life by lowering pulmonary arterial pressure and decreasing vascular resistance in patients with pulmonary arterial hypertension. Treprostinil, marketed as Remodulin®, is approved in the US and EU for pulmonary arterial hypert...

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

Treprostinil IV 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 Treprostinil IV 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 Treprostinil IV is more than procurement—it’s a strategic partnership. With its sc or intravenous (iv) form and 2 mg (0.1 mg/mL), 4 mg (0.2 mg/mL), 8 mg (0.4 mg/mL), 20 mg (1 mg/mL), 50 mg (2.5 mg/mL), 100 mg (5 mg/mL), 200 mg (10 mg/mL), or 400 mg (20 mg/mL) 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 Treprostinil IV