Suppliers and packagers for ATROVENT HFA

ATROVENT HFA

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	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0087-17	1 CANISTER in 1 CARTON (0597-0087-17) / 200 AEROSOL, METERED in 1 CANISTER	2005-05-01

ATROVENT HFA Suppliers (IP, Manufacturing, and Supply Chain) Who Makes the Brand Aerosol?

Last updated: June 1, 2026

ATROVENT HFA is a prescription inhalation aerosol of ipratropium bromide (CFC-free HFA formulation). The brand’s supplier landscape is anchored to the rights-holder/labeler responsible for FDA commercialization and the contract-manufacturing and fill-finish network supporting metered-dose inhalers (MDIs).

Who supplies ATROVENT HFA and who manufactures the ipratropium bromide MDI?

Primary supplier for the marketed product: Boehringer Ingelheim (labeler/holder responsible for the branded ATROVENT HFA drug product in the US).

Manufacturing structure for MDIs: ATROVENT HFA is typically produced through a split model used across the MDI industry:

• Drug substance and formulation manufacturing (active drug and excipient blending, HFA-compatible formulation)
• Aerosol can filling and closure (metered delivery hardware)
• Pack assembly and secondary packaging (cartonization, labeling, distribution release)

Commercially relevant supplier roles you should track in filings and inspections

• NDA/labeler entity (market authorizing party)
• Contract manufacturer for fill-finish and device integration
• Contract manufacturer for formulation and bulk blending
• Primary and secondary packaging suppliers

What companies are listed on the ATROVENT HFA FDA label and how do labeler and manufacturer differ?

ATROVENT HFA’s supply chain should be assessed in two layers that often differ in MDIs:

1. Labeler/Holder (responsible party): the company appearing as the applicant/holder on FDA materials and on the package label.
2. Manufacturers (operations): companies named as “manufactured for” or “distributed by,” which map to specific process steps.

For ATROVENT HFA, the labeler aligns to Boehringer Ingelheim. The manufacturer names appearing on specific product presentations (strength and package type) can change by lot and over time due to CMO rotation, so the correct approach is to match suppliers to the exact NDC and package configuration.

How do you map ATROVENT HFA suppliers to NDC-level sources and lot release?

MDI supply contracts are managed at the NDC and lot level. Mapping suppliers requires tracking:

• NDC (product/strength/form)
• lot number (batch identification)
• corresponding manufacturing site for fill-finish and assembly
• distribution channels (direct vs wholesaler)

Supplier shifts are common when:

• a CMO expands capacity
• device supplier changes MDI valve/can supply
• regulatory remediation triggers audit changes
• formulation scale-up moves to a different site

Which CMO and fill-finish capabilities matter for ATROVENT HFA?

ATROVENT HFA is an HFA metered-dose inhaler, so the supplier pool must have capabilities in:

• HFA-compatible formulation handling (moisture and valve interface control)
• Metering precision for dose consistency
• Aerosol can filling under controlled environmental conditions
• Valve assembly and leak testing
• Container-closure integrity validation
• Stability and compatibility testing for ipratropium bromide in HFA systems
• Device part sourcing (valve, actuator, stem, can)

In practice, this narrows supplier selection to CMOs with MDI track records, not general inhalation powders plants.

What patent or licensing entities affect who can supply ATROVENT HFA in the US?

The question of “suppliers” in the market is constrained by:

• the branded commercial rights holder (regulatory labeler)
• patent scope governing the ipratropium bromide HFA formulation and device-compatible delivery system
• generic and authorized generic entry status, which determines if competition reduces branded supply or reallocates manufacturing load

Even when manufacturing is outsourced, the labeler controls regulatory accountability for manufacturing changes and quality systems.

What generic or authorized-generic suppliers compete with ATROVENT HFA supply?

ATROVENT HFA faces competition from:

• generic ipratropium bromide HFA inhalers (ANDAs)
• potential authorized generics depending on settlement and distribution agreements
• legacy inhaled ipratropium presentations in other devices (not the same as HFA MDI)

The supplier impact is that branded ATROVENT HFA production is increasingly influenced by:

• whether competing products are launched and at what scale
• distribution contracting and wholesaler substitution
• manufacturing capacity allocation between brand and generics within CMOs

When do ATROVENT HFA exclusivity and patent terms affect supplier availability?

Supplier availability for the brand depends on two timelines:

• patent expiration for the branded HFA inhaler (formulation and method claims)
• regulatory exclusivity for specific NDA supplements (if any)

Once these protections expire and ANDA approvals come through, the branded labeler may still remain the supplier of the brand, but capacity and device purchasing can shift due to overall market economics.

How does ATROVENT HFA compare with Atrovent (nebulizer) in supplier requirements?

ATROVENT HFA (MDI) and other ipratropium products often differ in:

• dosage form device integration
• manufacturing and validation endpoints
• packaging and distribution stability specs
• supplier base (different CMOs for MDI vs nebulizer solutions)

MDI suppliers require valve/can integration and metering hardware testing, while nebulizer solutions focus on sterile manufacturing (depending on presentation) and solution stability.

What is the practical supplier checklist for ATROVENT HFA procurement?

If you are evaluating sources for ATROVENT HFA supply continuity, the procurement and quality due diligence checklist should cover:

• NDA labeler mapping to the correct NDC
• current manufacturing sites for fill-finish and device assembly
• audit history and inspection outcomes for MDI operations
• container-closure integrity and metering performance data
• device compatibility validation for HFA
• temperature and handling requirements during distribution
• lot release testing and reference standard management

Key Takeaways

• Boehringer Ingelheim is the key supplier role for ATROVENT HFA as the labeler commercial rights-holder in the US.
• ATROVENT HFA supply is typically delivered through specialized MDI contract manufacturing, split between formulation/bulk and fill-finish with valve/can integration.
• Supplier identification must be done at NDC and lot level because manufacturer and operations can shift with CMO capacity and device sourcing.
• Patent and regulatory status shapes competitive pressure from generic HFA ipratropium inhalers, which can indirectly alter manufacturing allocation and distribution contracts.

FAQs

1) Who is the labeler for ATROVENT HFA in the US?
Boehringer Ingelheim.

2) What manufacturing steps are most critical for ipratropium bromide HFA MDIs?
HFA-compatible formulation, metered filling, valve/can integration, leak and metering performance testing, and container-closure integrity validation.

3) How do I find the correct ATROVENT HFA manufacturer for my product?
Match the specific NDC and lot and then verify the “manufactured for” / site information on the package labeling or corresponding FDA listing details.

4) Do ATROVENT HFA suppliers differ from suppliers for ipratropium nebulizer solutions?
Yes. MDI devices require valve/can/metering manufacturing expertise, while nebulizer solutions use different process controls and validation.

5) What changes typically cause supplier rotation for MDIs?
CMO capacity expansion, device supplier changes, regulatory remediation, audit outcomes, and market-driven allocation between brand and generic production.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (ATROVENT HFA listings). https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA (ATROVENT HFA product information and labeler/applicant details). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory