Suppliers and packagers for generic pharmaceutical drug: ALBUTEROL SULFATE

ALBUTEROL SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Ireland Ltd	ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	211600	ANDA	Amneal Pharmaceuticals NY LLC	69238-1291-1	1 CANISTER in 1 CARTON (69238-1291-1) / 200 INHALANT in 1 CANISTER	2025-12-03
Armstrong Pharms	ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	212447	ANDA	Armstrong Pharmaceuticals, Inc.	17270-0740-0	1 INHALER in 1 CARTON (17270-0740-0) / 200 INHALANT in 1 INHALER	2024-08-06
Armstrong Pharms	ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	212447	ANDA	NuCare Pharmaceuticals,Inc.	68071-3902-2	1 INHALER in 1 CARTON (68071-3902-2) / 200 INHALANT in 1 INHALER	2024-08-06

Suppliers and packagers for generic pharmaceutical drug: ALBUTEROL SULFATE

Last updated: May 25, 2026

Albuterol Sulfate Suppliers: Who Manufactures Albuterol APIs, CMO-Managed Finished Dosage, and Key Value-Chain Sources

Albuterol sulfate’s supply base is fragmented across multiple tiers: API manufacturers, intermediate producers (including albuterol base or upstream syntheses), finished-dose manufacturers (nebulizer solutions, metered-dose inhalers, tablets), and contract manufacturing organizations (CMOs) that manage regulatory batches and fill-finish. Public procurement, FDA facility data, and common industry sourcing patterns typically place the most material risk in API availability, salt form consistency (sulfate vs free base), and inhalation device compatibility (particle engineering, propellant compatibility, and extractables/leachables controls).

What companies supply albuterol sulfate API (active pharmaceutical ingredient)?

Albuterol sulfate API is supplied by a mix of global generics API makers and specialty chemical manufacturers. In practice, many branded finished-dose manufacturers do not own API plants and buy either API directly or albuterol base plus salt conversion from approved suppliers, then finish the salt-form and crystallization to spec.

Typical API product definitions in supplier listings

• Albuterol sulfate, USP (or equivalent) grade
• Albuterol sulfate anhydrous vs hydrated form (controlled by supplier specification)
• Particle size distribution targets for inhalation-adjacent applications (if used in dry powder, not typical for standard albuterol sulfate inhalation products)
• Impurity controls for residual solvents, related substances, and aldehydes (route dependent)

API sourcing constraints that drive supplier selection

• Salt form verification (sulfate identity and polymorph control)
• Batch-to-batch impurity profile consistency
• Compliance status at FDA-registered facilities
• Ability to support DMFs/CEP dossiers where required by customers
• Lead times for regulated manufacturing slots and API release testing capacity

Which suppliers provide finished albuterol sulfate dosage forms (inhalers, nebulizer solutions, tablets)?

Finished-dose supply is dominated by branded and generic inhalation and oral product manufacturers plus fill-finish specialists.

Metered-dose inhaler (MDI) supply and contract manufacturing

MDIs require integrated device and formulation know-how: actuator compatibility, valve torque, canister crimp specs, and propellant/formulation interaction controls. Many suppliers split roles:

• Formulation and canister fill-finish (CMO)
• Device hardware supply (often distinct suppliers)
• Final assembly and labeling (often by the NDA/ANDA holder)

Nebulizer solution supply

Nebulizer solutions require:

• Sterile manufacturing capability (or use of outsourced sterile fill)
• Container closure integrity testing for multi-dose or unit-dose formats
• Preservative controls where applicable

Oral tablets and syrups

Oral formulations rely more heavily on:

• Blend uniformity and content uniformity control
• Moisture and dissolution profiling for salt-form stability
• Controlled-release differences if present (most albuterol oral products are immediate-release)

What patent or regulatory status affects supplier qualification for albuterol sulfate?

For suppliers, regulatory relevance comes from:

• FDA Drug Master File (DMF) linkages (API)
• ANDA or NDA formulation permissions (finished dosage)
• Facility registration and inspection outcomes
• Compliance history in sterile and inhalation product categories

How DMF-based sourcing typically works

• API suppliers hold DMFs for specific synthetic routes and control strategies.
• Finished-dose applicants reference the DMF in ANDAs for CMC sections.
• Supplier changes trigger comparability requirements (analytical and sometimes stability work).

When do albuterol sulfate supply constraints typically appear, and how do they impact availability?

Supply stress usually shows up around:

• API plant downtime and inspection remediation
• QC capacity bottlenecks (release testing, sterility testing, particle testing)
• Inhalation CMO slot constraints (fill-finish and primary packaging capacity)

These issues tend to cause localized shortages even when overall global demand is stable, because albuterol products are frequently produced by a limited number of qualified sterile and inhalation-capable facilities.

How strong is the supplier risk profile for albuterol sulfate versus other short-acting beta agonists?

Relative to other SNAs, albuterol sulfate has:

• Broad demand and long-standing generic penetration
• A supply base that can remain adequate but is sensitive to manufacturing disruptions in specific sterile/inhalation-capable nodes

Supplier risk is highest where:

• The product is sterile or has an inhalation device integration requirement
• Only a small number of sites hold the needed validated processes
• Salt-form and impurity controls are stringent and route-specific

Which CMOs and fill-finish providers are relevant to albuterol sulfate?

Albuterol finished-dose sourcing often uses CMOs for:

• Sterile filling (nebula solutions)
• Aseptic processing and terminal sterilization validation (depending on product)
• Blending and tablet compression (oral forms)
• Inhalation fill-finish and packaging (MDIs)

Inhalation-specific CMOs are selected based on:

• Metering valve/canister systems compatibility
• Propellant/formulation experience
• Extractables/leachables characterization and device component qualification

What manufacturing/IP barriers affect switching albuterol sulfate suppliers?

Switching suppliers is typically constrained by:

• Regulatory documentation: DMF updates or new DMF filings and FDA review cycles
• Analytical comparability: impurity profile matching, polymorph/salt form equivalence, particle and dissolution similarity
• Stability data: accelerated and long-term studies required by the applicant
• Device and formulation integration: inhalation products are harder to change due to actuator and valve compatibility

What generic entry risks exist for albuterol sulfate based on supply-chain bottlenecks?

Generic competition tends to increase demand for:

• Qualifying API and sterile fill capacity
• Device and packaging supply
• Release testing throughput

If key nodes experience downtime, new entrants may face delays in batch release even when regulatory approval exists, because supply-chain readiness determines commercial launch timing.

How does albuterol sulfate supplier coverage differ by geography?

Supplier coverage is generally strongest where:

• DMF-holding API manufacturing is established at scale
• Sterile and inhalation fill-finish capacity exists with demonstrated FDA compliance

For many applicants, global sourcing means:

• Multiple qualified API sources
• Backup filled-dose providers for sterile and inhalation steps
• Safety stocks for inhalation components (valves, canisters, labels, cartons)

What data should be used to identify the actual albuterol sulfate suppliers for a specific product?

For a specific albuterol sulfate product (by strength and dosage form), the practical approach is to triangulate:

• FDA Orange Book listing for the relevant NDA/ANDA product to identify applicant/holder (finished dose)
• FDA facility databases for the manufacturing site names (where available)
• DMF references in the ANDA for the API holder (where publicly indexed)
• Public procurement tenders and contract award notices tied to the product’s dosage form

Key Takeaways

• Albuterol sulfate supply is tiered: API makers, salt form and impurity-controlled intermediate steps, and dosage-form fill-finish.
• The highest operational risk concentrates in sterile and inhalation-capable nodes, and in API salt form and impurity specification adherence.
• Supplier switching is usually limited by DMF/CMC regulatory linkage, comparability analytics, and inhalation device integration constraints.

FAQs

1) How do I find the albuterol sulfate API DMF holders for a specific ANDA?
Use the ANDA’s publicly listed DMF references in FDA submissions where indexed and match the API application dossier language to the referenced DMF number and holder.

2) Which parts of the albuterol supply chain are most prone to shortages during inspections?
Sterile fill/aseptic processing for nebulizer solutions and inhalation fill-finish for MDIs, plus API release testing capacity constraints.

3) Can albuterol free base be substituted for albuterol sulfate by suppliers?
Not directly without reformulation and regulatory comparability because the salt form affects physicochemical properties and impurity profiles.

4) What supplier documentation matters most for albuterol sulfate salt-form consistency?
Certificates of analysis aligned with sulfate identity, polymorph/salt form confirmation, impurity profiles, and stability program data.

5) Do inhalation device components constrain albuterol sulfate manufacturing more than API does?
Often yes for MDIs, because valve, actuator, and canister compatibility can gate release even if API and formulation are available.

References

No sources were cited because no specific supplier list, facility names, DMF numbers, product NDA/ANDA identifiers, or Orange Book entries were provided in the request.