How to Source Ensifentrine for Pharmaceutical Formulation

Ensifentrine (Inhalation solution, 3 mg per 2.5 mL) is classified under Respiratory Disorder. It is therapeutically aligned with reference brands such as Ohtuvayre (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Ensifentrine for formulation, R&D, or bulk manufacturing.

Product Overview: Ensifentrine is an inhaled medication used for the maintenance treatment of chronic obstructive pulm...

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

Ensifentrine 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 Ensifentrine 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 Ensifentrine is more than procurement—it’s a strategic partnership. With its inhalation solution form and 3 mg per 2.5 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 Ensifentrine