Suppliers and packagers for SPIRIVA RESPIMAT

SPIRIVA RESPIMAT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100-28	1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE	2014-09-30
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100-51	1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE	2014-09-30
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100-61	1 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE	2014-09-30

Suppliers and packagers for SPIRIVA RESPIMAT

Last updated: May 29, 2026

SPIRIVA RESPIMAT (tiotropium bromide) suppliers: who manufactures, supplies, and processes the inhaler and drug substance

SPIRIVA RESPIMAT is a Boehringer Ingelheim inhalation product delivering tiotropium bromide via the RESPIMAT Soft Mist inhaler. Core supply chain components include: (1) tiotropium bromide drug substance, (2) inhalation formulation and filled canisters, and (3) the RESPIMAT inhaler device and its actuation mechanism. The product is marketed in the U.S. by Boehringer Ingelheim. The key suppliers for the product are those named in regulatory submissions and product manufacturing records tied to the marketing authorization holder.

Who supplies tiotropium bromide for SPIRIVA RESPIMAT?

Tiotropium bromide drug substance supply

SPIRIVA RESPIMAT uses tiotropium bromide (typically supplied as drug substance under commercial contract manufacturing models). In practice, industry supply is handled by:

• Chemical API manufacturers producing tiotropium bromide in compliance with GMP
• API packaging and release units feeding formulation plants
• Logistics and controlled-substance-style handling for inhalation-grade material

How to map API suppliers for enforcement and licensing

For diligence, supplier identification is done by triangulating:

• FDA/DMF references for the tiotropium bromide drug substance (if cross-referenced on-label or in establishment listings)
• Drug product manufacturing site disclosures (filled canister and device assembly)
• Inspection and consent-decree style establishment reporting for the listed manufacturing sites

Who manufactures the SPIRIVA RESPIMAT formulation and filled canisters?

Filled canister and solution manufacturing

SPIRIVA RESPIMAT contains a tiotropium bromide solution dispensed from a disposable cartridge/canister that is inserted into the reusable inhaler device. Manufacturing typically splits into:

• Sterile or controlled-atmosphere filling and stoppering for inhalation solutions
• Formulation blending, filtration, and in-process control testing
• Filling into canisters, labeling, and packaging
• Lot release testing for dose uniformity and delivered dose performance

Common supply-chain structure

Across marketed inhalation products of this type, the “supplier” stack usually includes:

• Formulation site (liquid manufacturing)
• Primary packaging site (canister filling)
• Secondary packaging site (carton, leaflets, distribution pack-outs)
• Quality-release and QA oversight tied to Boehringer Ingelheim’s marketing authorization

What suppliers make the RESPIMAT Soft Mist inhaler device for SPIRIVA?

Device and actuation mechanism supply

The RESPIMAT inhaler is a reusable actuation device that mates with the disposable canister. Device supply chain typically includes:

• Plastic component suppliers (polymer molding of housing and internal parts)
• Spring, seal, valve, and nozzle suppliers (machined or molded elastomer and polymer parts)
• Assembly lines for final device build and functional testing
• Component sterilization or cleanliness validation as required by assembly specs

Device qualification and regulatory linkage

Device supplier changes typically require:

• Material traceability and change control documentation
• Bioequivalence-related comparability work (delivered dose and particle/aerosol metrics)
• Regulatory update notifications where required for the marketing authorization

Which companies supply parts and subassemblies for the RESPIMAT platform?

Supplier categories

Inhaler platforms like RESPIMAT are built via contracted supply for:

• Molding and machining for the inhaler shell and internal carriers
• Valve and metering components
• Nozzle and aerosol-generation geometry components
• Assembly and QC test suppliers (leak tests, actuation force profiling, delivered dose verification)

How supplier identification is validated

For enforcement, litigation, or licensing, suppliers are validated through:

• Establishment registration and manufacturing site listings
• Regulatory submission traceability (CMC sections identifying manufacturers)
• Inspection reports tied to manufacturing establishments
• Supply agreements disclosed in regulatory or litigation filings

SPIRIVA RESPIMAT manufacturing and supply chain: supplier map by function

Supply chain function	What is supplied	Typical supplier type	Regulatory evidence to anchor supplier identity
Drug substance	Tiotropium bromide API	API contract manufacturer	DMF cross-reference, establishment data for API
Drug product	Tiotropium bromide solution formulation	Formulation/CMC manufacturer	NDA/BLA CMC site listing, facility inspection records
Primary packaging	Filled inhaler canisters/cartridges	Filling and packer manufacturer	Product label manufacturing statements, establishment lists
Device components	Housing, internal parts	Component molding/machining suppliers	Device component traceability in CMC, establishment data
Final device assembly	RESPIMAT assembled inhaler	Device assembly manufacturer	Manufacturing site lists for device assembly and QC
Release and distribution	QA release, logistics	Marketing authorization holder logistics	Product release records and distribution establishment data

U.S. regulatory status: why supplier identification matters

Orange Book and exclusivity doesn’t list suppliers

SPIRIVA RESPIMAT is protected by listed patents and associated exclusivities in the Orange Book, but the Orange Book does not identify manufacturing suppliers. Supplier identity comes from CMC and facility listings rather than patent listings.

FDA labeling manufacturing statements as the practical starting point

The most operational path to identify suppliers is to map:

• Labeled manufacturing sites
• Establishment registrations
• The DMF/CMC references for the drug substance and formulation

What generic or biosimilar supply risk exists for SPIRIVA RESPIMAT?

No biosimilar pathway

SPIRIVA RESPIMAT is a small-molecule inhalation drug, so the competitor risk is primarily generic inhaler products, not biosimilars.

Generic risk drivers

Supplier substitution risk is driven by:

• Delivered dose and aerosol characteristics
• Device-canister mating and dosing consistency
• Formulation and fill quality controls
• Device component tolerances and assembly QC

How do suppliers support litigation, licensing, and Paragraph IV disputes?

Supplier changes can trigger comparability and regulatory obligations

In inhalation devices, supplier changes affect delivered dose and fine-particle fraction. That can force:

• Additional comparability testing
• CMC updates and regulatory reporting
• Facility qualification and audit trails

Why supplier mapping becomes a leverage point

In licensing or Paragraph IV disputes, the supplier record supports:

• Design-around and non-infringing route analysis (device and formulation)
• Proving manufacturing similarity or differences
• Establishing whether a challenger can reliably replicate performance attributes

Commercial and operational exposure: supplier concentration

Inhaler platform concentration risk

RESPIMAT-type products rely on a coordinated supply chain:

• API supply continuity
• Liquid filling capacity
• Device assembly and component molding capacity Concentration risk arises if any one tier (device components, filled canister filling, API) is single-sourced without certified alternates.

Practical diligence items

Supplier risk reviews typically focus on:

• Capacity utilization at the relevant manufacturing sites
• Backup manufacturing qualification status
• Quality system compliance record for the establishments

Key Takeaways

• SPIRIVA RESPIMAT’s supply chain breaks into three practical supplier layers: tiotropium bromide drug substance, tiotropium bromide inhalation formulation and filled canisters, and the RESPIMAT device (components and final assembly).
• Supplier identities are anchored in regulatory CMC facility listings and establishment/DMF references, not in the Orange Book.
• Inhaler platform products create added supplier sensitivity because device-canister dosing performance is tightly linked to manufacturing tolerances and assembly QC.

FAQs

1. Where can I find the manufacturing site names for SPIRIVA RESPIMAT in U.S. regulatory records?
2. Do SPIRIVA RESPIMAT generic challengers need the same RESPIMAT device supplier or can they use alternates?
3. What CMC areas most often show supplier involvement for inhalation solution products like SPIRIVA RESPIMAT?
4. How do delivered-dose and aerosol performance requirements affect supplier qualification for inhaler devices?
5. Which supplier tier (API vs filled canisters vs device assembly) is usually the rate-limiting step during production scale-up?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
2. FDA Drug Establishment Registration and Listing (DELPHIS). U.S. FDA.
3. FDA Device classification and CMC guidance for combination products (as applicable to inhaler device-device interactions). U.S. FDA.