Suppliers and packagers for COMBIVENT RESPIMAT

COMBIVENT 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	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0024-02	1 CARTRIDGE in 1 CARTON (0597-0024-02) / 120 SPRAY, METERED in 1 CARTRIDGE	2012-07-01

Suppliers and packagers for COMBIVENT RESPIMAT

Last updated: April 25, 2026

Who Supplies COMBIVENT RESPIMAT (ipratropium bromide + albuterol sulfate) and What Do They Provide?

COMBIVENT RESPIMAT (ipratropium bromide monohydrate and albuterol sulfate) is a Boehringer Ingelheim brand product, manufactured and supplied through Boehringer Ingelheim’s commercial and contract manufacturing network in coordination with its own quality system and labeling filings. The marketed product’s supply chain is documented in regulatory product listings and labeling rather than in a single publicly enumerated “supplier list” by ingredient and step.

Brand owner and product-supply accountability

COMBIVENT RESPIMAT is marketed in the US under the Boehringer Ingelheim umbrella. The prescribing information identifies the responsible company and the distribution/labeling entity used for US commerce.

Item	Entity named in US product labeling	What it indicates for supply chain
US label responsibility	Boehringer Ingelheim Pharmaceuticals, Inc.	Commercial sponsor and supply accountability for marketed product (labeling, distribution, regulatory obligations)

What suppliers supply (by role)

Public filings do not typically name every upstream raw-material vendor for inhalation actives and excipients, but they do support the following supplier roles that matter for sourcing, tech transfer, and risk management:

Supplier role in an inhalation product	Typical sourcing components	Evidence basis
Marketing authorization holder / US label owner	Finished dosage form release for COMBIVENT RESPIMAT	US prescribing information
Active pharmaceutical ingredient (API) manufacturers	Ipratropium bromide monohydrate and albuterol sulfate	Ingredient listings in labeling, linked to regulatory submissions (no single vendor named in common public sources)
Propellant and inhaler device supply	HFA-134a (or equivalent) and device components for RESPIMAT	RESPIMAT platform documentation and inhaler-device supply chain through Boehringer Ingelheim and its device partners (device-specific component sourcing not fully enumerated publicly)
Contract manufacturers	Drug product manufacturing (fill/finish)	Quality/CGMP release practices and product distribution mapping in regulatory product databases

Supply chain map tied to the RESPIMAT platform

RESPIMAT is a specific inhaler platform that is integrated with Boehringer Ingelheim’s respiratory portfolio. For COMBIVENT RESPIMAT, the supply chain is organized around the RESPIMAT device system plus the medication cartridge filling and release under CGMP.

Workstream	What gets sourced	What to track in vendor diligence
Device system	Metered valve, actuator, cartridge components	Compatibility with dosing accuracy, seal integrity, and wear characteristics
Drug cartridge / fill-finish	Drug solution for the metered cartridge and in-container controls	Potency, impurities, container closure integrity, and particulate specs
Propellant	Metered propellant system for aerosolization	Vapor pressure controls, leak testing, and environmental handling

Regulatory and product-listing sources used to identify the responsible supplier

The most actionable “supplier” identification for COMBIVENT RESPIMAT in public material is the labeled responsible company (Boehringer Ingelheim Pharmaceuticals, Inc.) and the fact that the product is marketed as a Boehringer Ingelheim respiratory franchise using the RESPIMAT platform. This matters for contracting, because that entity controls regulatory compliance and the commercial release pathway.

US prescribing information anchor

The COMBIVENT RESPIMAT prescribing information includes the responsible US company and the inhalation product designation. That is the primary supplier reference point for commercial and regulatory engagement.

• Label entity: Boehringer Ingelheim Pharmaceuticals, Inc. (US label responsibility). (Source: COMBIVENT RESPIMAT prescribing information). [1]

Practical supplier shortlist for business workflows

For R&D/vendor onboarding, the supply chain is treated as follows (roles, not necessarily named raw-material vendors):

1. Boehringer Ingelheim Pharmaceuticals, Inc.
   Owns the US product label responsibility and coordinates supply and regulatory compliance for COMBIVENT RESPIMAT. [1]

2. RESPIMAT platform and device supply chain (Boehringer Ingelheim device ecosystem)
   Supplies the inhaler device system and cartridge components necessary for dosing. (Source: RESPIMAT platform usage in Boehringer Ingelheim inhalation products and COMBIVENT RESPIMAT product labeling). [1]

3. API and excipient manufacturers supplying CGMP-controlled inputs
   Provide ipratropium bromide monohydrate and albuterol sulfate plus formulation excipients under controlled quality agreements. (Actives and product composition appear in labeling; individual upstream vendors are generally not enumerated in public prescribing information). [1]

What to do with this information

For supplier identification, the defensible starting point for any contracting or due diligence is the US label owner named in the prescribing information and the RESPIMAT device platform used for the product. Upstream API vendor names typically require direct access to commercial contracts, regulatory CMC submissions beyond public summaries, or supplier qualification records maintained within the sponsor’s quality system.

Key Takeaways

• COMBIVENT RESPIMAT is Boehringer Ingelheim’s branded product with US label responsibility held by Boehringer Ingelheim Pharmaceuticals, Inc. [1]
• Public sources substantiate roles in the supply chain (device platform, drug product fill-finish, CGMP release), but commonly do not name every upstream API and excipient vendor in a public “supplier list.”
• For sourcing and diligence, the reliable supplier anchors are (1) the labeled sponsor/label owner and (2) the RESPIMAT device ecosystem tied to Boehringer Ingelheim’s inhalation manufacturing and distribution network. [1]

FAQs

1. Who is the label owner for COMBIVENT RESPIMAT in the US?
   Boehringer Ingelheim Pharmaceuticals, Inc. [1]

2. Does COMBIVENT RESPIMAT use the RESPIMAT inhaler platform?
   Yes. The product is marketed specifically as “RESPIMAT” and is supplied as a metered inhalation system using that device platform. [1]

3. Are the upstream API suppliers publicly listed in COMBIVENT RESPIMAT prescribing information?
   Not in the standard public prescribing information; it focuses on product indications, composition at a high level, and label responsibility rather than naming every raw-material manufacturer. [1]

4. What supply-chain workstreams matter most for vendor sourcing of COMBIVENT RESPIMAT?
   Device platform components, cartridge fill-finish/drug cartridge assembly, and CGMP-controlled inputs (APIs and excipients) released under sponsor quality systems. [1]

5. Which entity should be the contracting counterpart for the product supply?
   The best public anchor is the US label owner: Boehringer Ingelheim Pharmaceuticals, Inc. [1]

References

[1] Boehringer Ingelheim Pharmaceuticals, Inc. (n.d.). COMBIVENT RESPIMAT (ipratropium bromide and albuterol sulfate) prescribing information. Boehringer Ingelheim.