How to Source Tiotropium Bromide for Pharmaceutical Formulation

Tiotropium Bromide (Dry Powder for Inhalation (DPI), 18 mcg per capsule) is classified under Respiratory Disorder. It is therapeutically aligned with reference brands such as Spiriva® HandiHaler®(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Tiotropium Bromide for formulation, R&D, or bulk manufacturing.

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

Tiotropium Bromide 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 Tiotropium Bromide 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 Tiotropium Bromide is more than procurement—it’s a strategic partnership. With its dry powder for inhalation (dpi) form and 18 mcg per capsule 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 Tiotropium Bromide