Last updated: May 29, 2026
Stiolto Respimat (tiotropium bromide + olodaterol) is supplied through a value chain that typically includes (1) API manufacturing for tiotropium and olodaterol, (2) finished-dose manufacturing of the Respimat cartridge/solution, (3) device manufacturing for the Respimat inhaler platform, and (4) packaging and distribution by the marketing authorization holder.
Note: No supplier roster or contract-manufacturing assignments can be stated accurately from the information provided.
Who supplies the APIs for Stiolto Respimat (tiotropium + olodaterol)?
Stiolto Respimat contains two inhaled active ingredients, each requiring dedicated API sourcing.
Which companies supply tiotropium bromide for inhalation products?
Key commercial suppliers are usually tracked via drug master files (DMFs) and manufacturer disclosures on regulatory filings, but the underlying supplier list is not provided here.
Which companies supply olodaterol for inhalation products?
Olodaterol API is also typically sourced via DMFs and controlled-substance-free chemical supply chains; again, the supplier list is not provided here.
What supply chain nodes matter most for IP and quality?
For IP and litigation risk mapping, the critical nodes are:
- API DMF holders (scope of registered processes)
- Finished dosage form manufacturers (formulation/process patents)
- Device manufacturer and cartridge fill/assembly sites (device-process patents and regulatory change control)
What companies manufacture the finished Stiolto Respimat cartridge and solution?
Stiolto Respimat is supplied as a cartridge-based inhalation product using the Respimat system. Finished-dose manufacturing generally covers:
- formulation of the tiotropium/olodaterol solution
- cartridge filling and sealing
- labeling/packaging configuration for distribution markets
A complete, accurate supplier list requires the specific manufacturing site assignments and/or regulator listings. Those are not included in the prompt.
Who manufactures the Respimat device used for Stiolto Respimat?
The Respimat inhaler platform is a distinct industrial component from the drug solution. The supplier split typically includes:
- device design and injection molded components
- valve and spray mechanism assembly
- final device-pack integration with cartridges
A concrete supplier answer depends on the device OEM and assembly sites used for Stiolto in target jurisdictions, which is not provided.
What is the Orange Book status of Stiolto Respimat and does it name suppliers?
Stiolto Respimat is an FDA-listed drug product with potential Orange Book listings that identify:
- applicant/labeler
- drug product code
- patents tied to the product
However, without the specific Orange Book entry data, no supplier or labeler can be reliably derived.
What suppliers compete or supply generics/biosimilars for the tiotropium + olodaterol combination?
The commercial “supplier” question changes under generic entry scenarios:
- companies may source APIs from different DMF holders
- finished-dose manufacturing may shift to contract manufacturers
- device sourcing often remains centralized to the inhaler OEM
A defensible comparison requires:
- confirmed approved alternatives
- FDA labeler/manufacturer listings
- patent and regulatory pathway mapping
None of those inputs are present.
Key Takeaways
- Stiolto Respimat sourcing spans API manufacturing, finished-dose cartridge filling, and Respimat inhaler device supply.
- A specific “supplier list” cannot be stated accurately from the provided information.
- Supplier mapping for R&D, licensing, and litigation should be anchored to FDA/EMA labeling and regulatory filings that identify site-specific manufacturers, DMF holders, and device OEM responsibility.
FAQs
- How do I identify the API DMF holders for tiotropium and olodaterol used in Stiolto Respimat?
- Which manufacturing sites typically fill Respimat cartridges for combination inhalation products?
- Does the inhaler device OEM change when moving between markets or labelers for Stiolto Respimat?
- How can contract manufacturing shifts affect Stiolto Respimat patent or regulatory change-control risk?
- What regulatory documents list the manufacturer and packaging sites for Stiolto Respimat by country?
References
No sources were provided in the prompt, and no verifiable supplier-specific citations can be generated from the information available.
