PULMICORT FLEXHALER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949	NDA	A-S Medication Solutions	50090-2239-0	1 INHALER in 1 CARTON (50090-2239-0) / 120 AEROSOL, POWDER in 1 INHALER	2007-03-19
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949	NDA	A-S Medication Solutions	50090-6796-0	1 INHALER in 1 CARTON (50090-6796-0) / 120 AEROSOL, POWDER in 1 INHALER	2007-03-19
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949	NDA	A-S Medication Solutions	50090-7867-0	1 INHALER in 1 CARTON (50090-7867-0) / 120 AEROSOL, POWDER in 1 INHALER	2025-07-01
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949	NDA	H2-Pharma LLC	61269-509-06	1 INHALER in 1 CARTON (61269-509-06) / 60 AEROSOL, POWDER in 1 INHALER	2007-03-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 31, 2026

PULMICORT FLEXHALER suppliers: who manufactures budesonide inhalation powder and what’s in the supply chain?

Pulmicort Flexhaler (budesonide inhalation powder) supply is anchored by AstraZeneca as the brand owner and by manufacturing partners that produce drug product and, in many cases, drug substance. The active ingredient is budesonide. The inhalation device and packaging supply is handled by specialized device, fill-finish, and logistics vendors under AstraZeneca’s control.

Core supplier categories for Pulmicort Flexhaler

Drug substance (budesonide) producers: specialty chemical API manufacturers that supply AstraZeneca (or its authorized contractors) with budesonide bulk API.
Drug product (inhalation powder) manufacturers: sterile-to-nonsterile solid-dose inhalation powder sites that perform blending, milling, filling, and final packaging.
Device and component suppliers: suppliers of the Flexhaler inhalation mechanism, plastic housings, dose counters, and other molded components (device sourcing is typically outside the API supply chain).
Pack-out and labeling/logistics: packaging contractors and distributors that handle blisters/strips, carton printing, serialization, and country-specific distribution.

Who supplies Pulmicort Flexhaler in the US and which companies manufacture it?

Answer (commercial sourcing pattern): Pulmicort Flexhaler is supplied by AstraZeneca to US wholesalers and specialty pharmacy channels, while manufacturing is performed by AstraZeneca-owned or contract manufacturing organization sites that produce budesonide inhalation powder under AstraZeneca quality systems.

How to identify Pulmicort Flexhaler manufacturing sites

The most reliable way to confirm “who supplies” in regulatory terms is via:

FDA labeling (US package insert): lists the manufacturer/distributor and sometimes the manufacturing site.
FDA drug product application and facility listing: identifies manufacturing facilities tied to the approved NDA.
Supply chain disclosures in regulatory submissions and inspection databases: show facility-level responsibility rather than full upstream supplier identity.

What counts as “supplier” for inhalation powder

For Pulmicort Flexhaler, supplier identification typically splits into:

AstraZeneca (labeler / MAH)
Drug product manufacturing facilities (blend/fill/pack)
API (budesonide) manufacturers (drug substance)
Flexhaler device component suppliers (device engineering and molded parts)

What suppliers provide budesonide (API) for Pulmicort Flexhaler?

Answer (structure of the API chain): Budesonide API is sourced from specialized chemical manufacturers. Exact API supplier names are typically not listed in consumer-facing labeling; confirmation generally requires facility-level NDA data, inspection records, or supplier disclosures in regulatory dossiers.

API supplier model used for inhaled corticosteroids

Budesonide is produced via chemical synthesis routes that support consistent polymorph and impurity profiles. API supply tends to be controlled through:

Qualified manufacturing sites
Batch-release testing under AstraZeneca specifications
Change-control approvals for impurity profile and particle characteristics

Which companies manufacture Pulmicort Flexhaler drug product (inhalation powder)?

Answer (manufacturing responsibility): Drug product manufacturing is carried out by AstraZeneca or contractors at approved inhalation powder manufacturing facilities that handle:

Powder blending and granulation (as applicable by the formulation)
Micronization and particle-size control
Dose metering performance validation
Filling into dose containers compatible with the Flexhaler device
Carton and label pack-out, including child-resistant packaging where required

Device-integrated product: why it affects suppliers

Pulmicort Flexhaler uses a breath-activated dry powder inhaler. The supplier chain must align:

Metering uniformity
Powder flowability (cohesiveness, moisture sensitivity)
Dose counter and mechanical tolerances in the inhaler housing
Packaging compatibility to preserve performance

What suppliers provide the Flexhaler inhaler device and components?

Answer (device supply category): Flexhaler device components are supplied by dedicated device sourcing and injection-molding vendors, then assembled and paired with the filled inhaler reservoir by AstraZeneca or its device integration partners.

Device components typically sourced

Molded plastic body and mouthpiece
Dose counter mechanism
Metering chamber and internal moving components
Induction and assembly hardware (springs, gears, stoppers depending on the version)

How do suppliers tie into FDA Orange Book status and exclusivity?

Answer: Supplier and manufacturing responsibility do not change exclusivity, but facility-level manufacturing is directly relevant to:

Generic bioequivalence and label compatibility
Regulatory readiness for supply continuity
Ability to demonstrate sameness for inhalation powder performance characteristics

Where Orange Book intersects with sourcing

The Orange Book lists approved drugs, active ingredients, dosage forms, and applicants.
It does not enumerate upstream API or device suppliers.
Practical supplier determination relies on labeling, application, and facility records.

Which manufacturing and packaging suppliers support international Pulmicort Flexhaler distribution?

Answer (international sourcing model): AstraZeneca typically uses a portfolio approach:

Multiple manufacturing sites to manage lead times and regulatory requirements
Local packaging contractors for country-specific labeling, serialization, and distribution
Device and pack logistics tailored to destination markets

Regulatory-driven differences by country

Serialization mandates (e.g., EU)
Local language labeling and leaflets
Importation and temperature handling requirements for powders

What generic entry risks exist for Pulmicort Flexhaler based on supplier constraints?

Answer: Supply-chain bottlenecks can slow generic entry execution in inhalation powders when:

The device integration is complex
Particle engineering and metering performance must match tightly
API and excipient sourcing is constrained
Device part compatibility requires validated assembly lines

Why supplier readiness matters for inhaled generics

Even if formulation IP expires, generics must still show:

Device-dosage consistency
Inhaler resistance and plume characteristics consistent with bioequivalence expectations
Robust manufacturing and release testing

How does Pulmicort Flexhaler compare with other budesonide inhalers in terms of supplier landscape?

Answer (high-level comparison): Other budesonide dry powder inhalers and nebulized forms often use different devices (and therefore different device supply chains), while API sourcing remains broadly similar because budesonide is the same active ingredient.

Supplier differences by delivery system

Dry powder inhalers: device integration and powder-metering suppliers dominate
Nebulized budesonide: sterile filling and container/closure suppliers dominate
Metered-dose inhalers: propellant and canister suppliers dominate

What patent and litigation landscape affects suppliers for Pulmicort Flexhaler supply continuity?

Answer: Patent or regulatory challenges do not typically block contract manufacturing unless:

There are injunctions tied to specific formulations, device components, or manufacturing methods
Orange Book-listed patents are challenged and settlements alter authorized production timelines

Supplier impact pathways

Settlement agreements can define “at-risk” manufacturing start dates
Licensing can allow authorized manufacturing using specified facilities or processes
Injunctions can constrain specific inhaler device designs

Timeline: when do supplier constraints typically change for Pulmicort Flexhaler?

Answer: Changes in supplier mix generally follow:

Major facility approvals or new manufacturing site transfers
Device revision cycles
Country-level relabeling or serialization upgrades
Regulatory inspections that require remediation, causing temporary production reallocation

Key Takeaways

Pulmicort Flexhaler’s “supplier” landscape is best understood as a regulated chain: AstraZeneca as brand owner, plus approved drug product manufacturing facilities, budesonide API producers, and Flexhaler device component suppliers.
Upstream API and device supplier names are rarely visible in consumer labeling; confirmation generally requires NDA-level facility records and regulatory documentation.
Inhalation powder generics and biosimilar-style challenges are less about brand ownership and more about whether suppliers can replicate device-powder performance under tight quality systems.

FAQs

Are Pulmicort Flexhaler inhaler devices and drug product manufactured by the same suppliers?
Usually device components and drug product are sourced and manufactured via different specialized suppliers, then assembled/paired under AstraZeneca’s process controls.
Where can I confirm the manufacturer of Pulmicort Flexhaler drug product?
The US package insert/labeling and FDA facility information associated with the approved NDA are the primary confirmation points.
Does the API supplier for budesonide change over time for Pulmicort Flexhaler?
It can change when AstraZeneca qualifies new API sites, but regulatory approval and specification control keep the product performance consistent.
What parts of the supply chain are most difficult to replicate for generic Pulmicort Flexhaler?
Dry powder metering performance and device integration are typically the hardest parts to replicate, not just the API.
Do packaging and serialization requirements create different suppliers by country?
Yes. Country-specific labeling, serialization, and distribution requirements commonly lead to local packaging and logistics vendor involvement.

References

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
U.S. Food and Drug Administration. Drug Approval Package and labeling for Pulmicort Flexhaler (budesonide inhalation powder).
U.S. Food and Drug Administration. FDA databases for drug product manufacturing facilities (facility/inspection and application records).

Suppliers and packagers for PULMICORT FLEXHALER