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Last Updated: March 27, 2026

Suppliers and packagers for generic pharmaceutical drug: ALBUTEROL SULFATE; BUDESONIDE


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ALBUTEROL SULFATE; BUDESONIDE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Astrazeneca AIRSUPRA albuterol sulfate; budesonide AEROSOL, METERED;INHALATION 214070 NDA AstraZeneca Pharmaceuticals LP 0310-9080-12 1 INHALER in 1 CARTON (0310-9080-12) / 120 AEROSOL, METERED in 1 INHALER 2023-10-02
Astrazeneca AIRSUPRA albuterol sulfate; budesonide AEROSOL, METERED;INHALATION 214070 NDA AstraZeneca Pharmaceuticals LP 0310-9080-28 1 INHALER in 1 CARTON (0310-9080-28) / 28 AEROSOL, METERED in 1 INHALER 2023-10-02
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers of ALBUTEROL SULFATE and BUDESONIDE

Last updated: February 20, 2026

Who are the primary manufacturers and global suppliers for ALBUTEROL SULFATE and BUDESONIDE?

Market Overview

Both ALBUTEROL SULFATE and BUDESONIDE are high-demand respiratory medications. ALBUTEROL SULFATE, a short-acting beta-agonist (SABA), is used for acute bronchospasm. BUDESONIDE, a corticosteroid, is employed for long-term management in asthma and COPD.

Multiple pharmaceutical companies and active pharmaceutical ingredient (API) suppliers produce these compounds, with manufacturing concentrated in North America, Europe, and Asia.


Major Raw Material and API Suppliers

Supplier Location Produces Note
GlaxoSmithKline UK ALBUTEROL SALFATE API Proprietary production
Novartis Switzerland BUDESONIDE API Proprietary production
Cipla India Both APIs Major generic supplier
Sun Pharmaceutical India Both APIs High-volume producer
Teva Pharmaceuticals Israel BUDESONIDE API and formulations
Europharmixa Poland ALBUTEROL SULFATE API, primarily for generics
Jiangsu Hengrui Medicine China Both APIs Growing presence in API market

API Manufacturing

Major API producers for ALBUTEROL SULFATE include GlaxoSmithKline, Cipla, and Europharmixa. For BUDESONIDE, Novartis, Teva, and Jiangsu Hengrui Medicine are significant.

API supply chains often involve multiple tiers: initial synthesis, purification, and formulation.


Finished Dosage Form Suppliers

Company Region Product Types Market Presence
Teva Pharmaceuticals Global Inhalers, nebulizers Largest market share in generics
Mylan Global Metered-dose inhalers (MDIs) Diversified portfolio
AstraZeneca Global BUDESONIDE inhalers Proprietary inhaler devices
Cipla India Both medications Leading regional generic supplier
Gibson Healthcare Asia Both medications Price-competitive manufacturing

Formulation and Delivery Devices

Manufacturers of formulations include GSK, AstraZeneca, and Teva, who also develop inhaler devices. Many generics focus primarily on API supply, outsourcing formulation.


Regulatory and Market Notes

  • USFDA Approvals: Most top-tier suppliers have approved facilities for API manufacturing compliant with US and European standards.
  • Global Supply: Increased demand for generic formulations has expanded manufacturing capacity in India and China.
  • Export Trends: APIs are exported primarily to Europe, North America, and Asia; formulations mainly target domestic markets and export under licensing agreements.

Supply Chain Considerations

  • API sourcing may involve multi-tiered contracts with component suppliers across Asia.
  • Manufacturers like Cipla and Sun Pharma leverage large-scale production to meet global demand.
  • Supply disruptions are possible due to geopolitical factors, regulatory delays, or raw material shortages, especially for complex synthesis steps.

Key Takeaways

  • Both drugs are produced by a mixture of global pharmaceutical companies and regional generics manufacturers.
  • API production is concentrated in India, China, Europe, and North America.
  • Major finished product manufacturers include Teva, Mylan, AstraZeneca, and Cipla.
  • Supply chain risks involve geopolitical upheaval and raw material scarcities.

Frequently Asked Questions

1. Who produces the active ingredients for ALBUTEROL SULFATE and BUDESONIDE?
Globally recognized API producers include GlaxoSmithKline, Novartis, Cipla, Sun Pharma, Teva, and Jiangsu Hengrui Medicine.

2. Are there region-specific suppliers for these drugs?
Yes. Indian companies primarily supply APIs and generics for Asian and developing markets. European and American firms focus on proprietary manufacturing and regulated markets.

3. Can smaller companies source these APIs directly?
Typically, only large pharmaceutical firms or licensed API distributors can source directly, due to regulatory, quality, and volume constraints.

4. How are manufacturing capacities impacted by global supply chain issues?
COVID-19 and geopolitical tensions have affected capacity, leading to shortages and increased reliance on regional suppliers.

5. What are the main risks in the supply chain for these drugs?
Risks include raw material shortages, regulatory delays, geopolitical tensions, and manufacturing disruptions.


References

  1. U.S. Food & Drug Administration. (2021). API Manufacturing Regulations. https://www.fda.gov
  2. MarketWatch. (2022). Global Inhaler Market Analysis. https://www.marketwatch.com
  3. European Medicines Agency. (2022). API Compliance and Inspection Reports. https://www.ema.europa.eu
  4. IQVIA. (2023). Global API Market Trends. https://www.iqvia.com
  5. Pharma Export Data. (2022). API and Finished Formulation Shipments. https://trade.gov

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