Suppliers and packagers for TUDORZA PRESSAIR

TUDORZA PRESSAIR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002-01	1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	2015-07-01
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002-02	1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	2015-07-01
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002-03	1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	2015-07-01

TUDORZA PRESSAIR Suppliers and Manufacturing: Who Makes It, Who Supplies Key Components, and How to Vet Vendor Risk

Last updated: June 3, 2026

TUDORZA PRESSAIR (aclidinium bromide inhalation powder) is supplied as a branded inhalation product built around a specific inhaler platform (“Pressair”) and a formulation of aclidinium bromide. The product’s supplier stack is typically split across (1) drug substance and drug product manufacturers, and (2) inhaler device and component suppliers. Public-facing procurement and regulatory artifacts generally confirm the primary drug-product and device platform suppliers, while many sub-component vendors (valves, cartridges, sensors, inks, adhesives) are not disclosed in a single public source.

Because “suppliers” can mean different layers (marketing authorization holder, contract manufacturer, device manufacturer, or component suppliers), this supplier map is best grounded in FDA labeling, regulatory filings (Orange Book/Drug Master Files if disclosed), and device sourcing disclosures tied to the specific inhaler platform used for TUDORZA PRESSAIR.

Who supplies TUDORZA PRESSAIR (aclidinium bromide) drug product and inhaler device?

Short answer: TUDORZA PRESSAIR is supplied as a fixed combination of an aclidinium bromide dry powder formulation and a Pressair inhaler device. The supply chain is divided between (a) drug substance and drug product manufacturing and (b) the Pressair platform and its inhaler components.

What entity is the marketing authorization holder for TUDORZA PRESSAIR in the US?

The US commercial identity for TUDORZA PRESSAIR is tied to the product label and US distribution. The FDA label identifies the commercial sponsor and the inhaler/device platform used for packaging and distribution.

What entity manufactures the Pressair inhaler used for TUDORZA PRESSAIR?

The Pressair inhaler platform is manufactured as a device system, with multiple mechanical and packaging components. Device manufacturing responsibility is typically reflected in labeling and device-related submissions and in the distribution chain for the finished inhaler.

Who manufactures the aclidinium bromide dry powder drug product for TUDORZA PRESSAIR?

The aclidinium bromide drug product is manufactured as a dry powder filled into the device to enable dose delivery. Inhalation powder products usually rely on a contract manufacturing network for powder blending, milling, containment, filling, and primary packaging, with strict QC release testing.

What drug substance and drug product manufacturing suppliers support aclidinium bromide inhalation powder?

Short answer: Drug substance and drug product manufacturers for inhaled dry powder drugs are commonly separate. For TUDORZA PRESSAIR, the supply chain typically includes a drug substance manufacturer for aclidinium bromide and a contract drug product manufacturer that produces the filled inhalation powder presentation.

Which manufacturing stages are sourced?

For TUDORZA PRESSAIR-style dry powder inhalation products, supplier responsibility often spans:

• Aclidinium bromide API synthesis and QC release (drug substance)
• Dry powder formulation and blending (drug product)
• Filling into device-compatible reservoirs/dose units
• Primary packaging and labeling
• Sterility assurance is not applicable (dry powder), but microbial and particulate specifications apply
• Device integration into the finished combination product

What quality systems and documentation define supplier vetting?

High-risk vendor diligence for an inhalation combination product generally relies on:

• cGMP compliance evidence
• master batch record controls for powder blending and filling
• containment and particulate control for inhalation powders
• device integration validation (dose delivery performance and plume characteristics)
• post-market complaint handling, CAPA response times, and recall readiness

Which Pressair inhaler suppliers provide the device and components?

Short answer: Pressair is a proprietary dose delivery inhaler platform, so vendor responsibility usually includes the device assembler and sub-component suppliers for dose meters, flow paths, actuators, and internal mechanical parts.

What components are typically supplied for Pressair-based products?

Device supply chains for inhalation powders commonly include suppliers for:

• Dose mechanism and mechanical actuation parts
• Internal flow channels and dose dispersion structures
• Metering and sealing components
• Dose counter and visual confirmation elements (where present)
• Packaging components (unit cartons, labels, desiccants, and protective foils)

How does component sourcing affect regulatory risk?

Component substitutions without approval can alter:

• emitted dose,
• aerodynamic particle size distribution,
• device resistance,
• dose uniformity across airflow ranges, and
• moisture uptake behavior of the powder.

For combination products, device changes can trigger supplemental CMC filings and may require bridging studies.

What Orange Book, FDA labeling, and regulatory artifacts identify TUDORZA PRESSAIR suppliers?

Short answer: Supplier identification for a commercial inhaler typically comes from FDA labeling (listed manufacturers/distributors), product submission summaries, and Orange Book-linked references where available.

Where to extract supplier names for TUDORZA PRESSAIR?

The most direct public source is the FDA package insert and label sections that list:

• manufacturer and/or sponsor,
• distribution entity,
• and sometimes the device platform manufacturer in combination-product contexts.

What Orange Book information helps with supply-chain mapping?

Orange Book listings identify:

• application type and sponsor,
• sometimes patent-linked product identities,
• and drug product/manufacturer details in structured label fields.

Orange Book does not reliably list device component suppliers. It is stronger for identifying the drug product application and its labeled manufacturer.

Which companies are likely to be in the active manufacturing supply chain?

Short answer: For branded inhalers, the manufacturing supply chain is often held by large CDMOs for powder filling and device assembly plus the device platform owner or its contract device manufacturer.

How to interpret “supplier” vs “manufacturer” on label and filings?

• “Manufacturer” on label often corresponds to the finished dosage combination product.
• “Sponsor” corresponds to marketing authorization holder and regulatory responsibility.
• “Device manufacturer” may be disclosed through combination product references rather than Orange Book.

Practical vendor mapping logic for procurement

A reliable procurement vendor map for TUDORZA PRESSAIR typically uses:

1. Finished product label manufacturer/distributor as the anchor.
2. Device platform identification from product visuals and filing references.
3. Separate API and drug product contract manufacturers using cGMP evidence, DMF references where disclosed, and facility inspection histories where available.

What substitution constraints exist if you swap suppliers for TUDORZA PRESSAIR?

Short answer: Supplier changes in inhalation dry powder combination products are tightly constrained by CMC comparability requirements.

What changes typically require regulatory notification or approval?

Changes that can trigger regulatory review include:

• API manufacturer or API grade without bridging
• powder formulation process changes that affect particle size distribution
• filling and device integration changes affecting dose uniformity
• device component material or geometry substitutions impacting aerosol performance

What evidence is typically needed for comparability?

Comparability packages usually include:

• physicochemical characterization,
• aerodynamic performance testing,
• dose uniformity across actuation and airflow conditions,
• stability data for the new supply chain,
• and device performance verification under USP inhalation test conditions.

How does the supplier landscape affect generic and biosimilar/ANDA entry risk?

Short answer: For inhalation powders, device dependency makes “generic” performance harder than for simple oral solids. Even if API is the same, device and powder performance can differ.

What is the key market risk for supplier changes?

If a generic applicant relies on different device internals or different powder blend behavior, performance bridging can become a gating factor, affecting:

• ANDA approval timelines,
• litigation exposure on performance claims, and
• launch timing.

How strong is TUDORZA PRESSAIR’s supplier defensibility?

Short answer: Defensibility is primarily tied to:

• device platform integration knowledge,
• manufacturing know-how for dose delivery performance, and
• CMC package strength, including validated manufacturing controls.

Supplier dependencies can reduce the ability of third parties to enter quickly with equivalent aerosol performance.

Key Takeaways

• TUDORZA PRESSAIR is a combination product: aclidinium bromide dry powder plus the Pressair inhaler device.
• Supplier identification in public records most reliably anchors on FDA label manufacturer/sponsor details for the finished product; device sub-components are not typically disclosed in a single consolidated public source.
• In inhalation dry powder products, vendor changes are high-friction due to dose uniformity and aerosol performance comparability requirements.
• Procurement and litigation readiness depend on mapping both drug product manufacturing and device integration responsibilities, not only API sourcing.

FAQs

1) Who makes the Pressair inhaler for TUDORZA PRESSAIR?

The Pressair inhaler is a proprietary dose delivery platform. The maker is identified through FDA labeling and device/platform references for the specific finished combination product.

2) Does TUDORZA PRESSAIR use a single supplier for both the drug and the device?

Typically no. Branded inhaler supply chains separate drug substance, drug product manufacturing, and device assembly due to specialized capabilities and validated CMC workflows.

3) What supplier change is hardest to substitute for an inhalation powder like TUDORZA PRESSAIR?

Device component and integration changes are often the hardest, because they can alter aerosol performance and dose uniformity in ways regulators view as material.

4) Where can I find the legal manufacturer of TUDORZA PRESSAIR in the US?

The FDA label’s “Manufactured for”/sponsor/distributor sections are the most direct public anchor for the finished product.

5) Can a generic of TUDORZA PRESSAIR launch without using the same inhaler device platform?

Generic performance depends on device behavior and powder-device interaction. Even with the same active ingredient, differences in inhaler design can require extensive bridging to demonstrate equivalent aerosol performance.

References (APA)

1. FDA. (n.d.). Drug Labeling for TUDORZA PRESSAIR (aclidinium bromide) Inhalation Powder. U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.