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Last Updated: December 13, 2025

Suppliers and packagers for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE


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ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Cipla ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077559 ANDA Cipla USA Inc. 69097-173-53 6 POUCH in 1 CARTON (69097-173-53) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 2007-12-31
Cipla ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077559 ANDA Cipla USA Inc. 69097-173-64 12 POUCH in 1 CARTON (69097-173-64) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL 2007-12-31
Luoxin Aurovitas ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 206532 ANDA Aurobindo Pharma Limited 65862-906-03 30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE 2020-07-09
Luoxin Aurovitas ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 206532 ANDA Aurobindo Pharma Limited 65862-906-30 6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE 2020-07-09
Luoxin Aurovitas ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 206532 ANDA Aurobindo Pharma Limited 65862-906-60 12 POUCH in 1 CARTON (65862-906-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 2020-07-09
Nephron ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076749 ANDA Nephron Pharmaceuticals Corporation 0487-0201-01 30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE 2007-12-31
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drugs: Albuterol Sulfate and Ipratropium Bromide

Last updated: August 8, 2025

Introduction

In the global pharmaceutical landscape, the supply chain for critical respiratory medications such as Albuterol Sulfate and Ipratropium Bromide is pivotal. These drugs are foundational in managing chronic obstructive pulmonary disease (COPD), asthma, and other obstructive airway conditions, making their reliable sourcing integral to healthcare providers and pharmaceutical distributors worldwide. This analysis details key suppliers, their market share, manufacturing capabilities, regulatory compliance, and strategic considerations to inform procurement decisions.

Market Overview

Albuterol Sulfate, a beta-2 adrenergic receptor agonist, and Ipratropium Bromide, an anticholinergic bronchodilator, are commonly formulated individually or in combination inhalers. The demand for these drugs has surged globally due to rising respiratory illnesses and pandemic influences. The global inhaler market was valued at over USD 20 billion in 2021, with a compound annual growth rate (CAGR) of approximately 4% (Research and Markets, 2022).

Major Suppliers and Manufacturers

1. Teva Pharmaceutical Industries Ltd.

As one of the world's leading generic medication manufacturers, Teva supplies Albuterol Sulfate and Ipratropium Bromide in various formulations, including inhalers, nebulizers, and solution vials. Their extensive manufacturing infrastructure across North America, Europe, and Asia ensures high volume and quality standards aligned with regulatory agencies like the FDA and EMA ([1]).

2. Glenmark Pharmaceuticals

Glenmark has a significant presence in the respiratory segment, producing both drugs in multiple formulations. Their formulations include inhalers, dry powders, and nebulization solutions. The company emphasizes research and development, ensuring compliance with global quality standards and the ability to meet regional demands ([2]).

3. Cipla Limited

An Indian multinational with a robust respiratory portfolio, Cipla manufactures Albuterol Sulfate and Ipratropium Bromide inhalation solutions and inhalers. Their strategic manufacturing sites in India and abroad allow for competitive pricing and rapid distribution, especially in emerging markets ([3]).

4. Sandoz (a Novartis division)

Sandoz supplies generic respiratory medications, including Albuterol and Ipratropium formulations. Their global network facilitates access to high-quality drugs, with stringent adherence to US and European regulatory standards ([4]).

5. Mylan (now part of Viatris)

Viatris' Mylan segment offers a broad portfolio of inhalation products, including both active pharmaceutical ingredients (APIs) and finished dosage forms of Albuterol Sulfate and Ipratropium Bromide. Their extensive manufacturing footprint and focus on quality assurance make them key players ([5]).

API Suppliers

For pharmaceutical companies integrating APIs into their manufacturing, key API suppliers include:

  • Hefei Bomei Medical Technology Co., Ltd. — based in China, producing bulk APIs for respiratory drugs.

  • Sun Pharmaceutical Industries Ltd. — India, with significant API manufacturing capabilities.

  • Lark Laboratories — India, supplying high-quality APIs with GMP compliance.

  • Hikal Ltd. — India, known for custom synthesis and API production for respiratory drugs.

Regional Supply Chain Dynamics

The supply chain for Albuterol Sulfate and Ipratropium Bromide is highly regionalized:

  • North America & Europe: Dominated by pharmaceutical giants like Teva, Sandoz, and Mylan, with stringent regulatory oversight ensuring high-quality standards for both APIs and finished formulations.

  • Asia & Emerging Markets: India and China serve as hubs for cost-effective API manufacturing and finished product assembly, facilitating affordable respiratory medications globally.

Regulatory and Quality Assurance Considerations

Suppliers must demonstrate compliance with international standards such as Good Manufacturing Practice (GMP), ISO certifications, and meet regulatory requirements of target markets like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory audits and quality certifications are critical selection criteria for procurement.

Strategic Sourcing and Risk Management

Diversification of suppliers mitigates risks linked to supply disruptions, regulatory hurdles, or geopolitical issues. Establishing long-term relationships with multiple suppliers enhances supply security and facilitates customization for specific regional needs. Advanced procurement analytics help forecast demand and identify capacity shortfalls.

Emerging Trends and Future Outlook

The drive toward bioequivalent inhalers and innovative drug delivery systems influences supplier strategies. Suppliers investing in advanced manufacturing processes, digital quality monitoring, and sustainable practices are better positioned for future market expansion.

Innovations such as dry powder inhalers (DPIs), soft mist inhalers, and combination therapies increase demand for versatile suppliers capable of meeting evolving technology standards.

Conclusion

Key suppliers for Albuterol Sulfate and Ipratropium Bromide encompass global pharmaceutical giants, regional manufacturers, and API producers. Ensuring supply chain resilience requires comprehensive assessment of supplier compliance, production capacity, and regional distribution capabilities. Strategic diversification, rigorous quality assurance, and adherence to regulatory standards underpin a robust sourcing strategy.


Key Takeaways

  • The leading manufacturers of Albuterol Sulfate and Ipratropium Bromide include Teva, Glenmark, Cipla, Sandoz, and Viatris, supported by a broad API supply network primarily based in India and China.

  • Reliable sourcing hinges on regulatory compliance, quality certifications, and manufacturing capacity, especially given stringent global standards from agencies like the FDA and EMA.

  • Regional supply dynamics favor North American and European markets for high-quality APIs, while Asia plays a crucial role in cost-effective manufacturing.

  • Diversification of suppliers reduces supply chain risks, ensures uninterrupted access, and caters to regional demand nuances.

  • Staying abreast of technological trends and regulatory updates shapes procurement strategies toward future-ready suppliers.


FAQs

Q1. What are the main considerations when selecting suppliers for Albuterol Sulfate and Ipratropium Bromide?
A1. Key considerations include regulatory compliance (GMP standards), manufacturing capacity, quality certifications, price competitiveness, supply chain reliability, and the supplier's ability to meet regional regulatory requirements.

Q2. Are there notable differences in suppliers based on geographical regions?
A2. Yes. North American and European suppliers typically offer higher regulatory compliance and quality assurance, whereas Asian suppliers provide cost-effective bulk APIs and formulations suited for emerging markets.

Q3. How does the API supply chain impact drug manufacturing?
A3. The quality, consistency, and availability of APIs directly influence the safety, efficacy, and manufacturing continuity of respiratory medications like Albuterol and Ipratropium Bromide.

Q4. What emerging trends influence supplier selection for respiratory drugs?
A4. Trends include the adoption of advanced inhaler technologies, focus on sustainability, digital manufacturing monitoring, and the development of combination therapies, all requiring suppliers to innovate and adhere to evolving standards.

Q5. How can companies mitigate risks related to supplier dependence?
A5. By diversifying supplier sources, establishing long-term contractual agreements, maintaining inventory buffers, and continuously monitoring supplier performance and regulatory status.


References

[1] Teva Pharmaceutical Industries Ltd. Corporate Reports, 2022.
[2] Glenmark Pharmaceuticals Annual Report, 2022.
[3] Cipla Ltd. Investor Presentation, 2022.
[4] Sandoz, Novartis Group, Global API Network Data, 2022.
[5] Viatris Mylan Portfolio Overview, 2022.

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