ALBUTEROL SULFATE; BUDESONIDE: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
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

Last updated: July 29, 2025

Introduction

The global pharmaceutical market for respiratory drugs, specifically for conditions such as asthma and chronic obstructive pulmonary disease (COPD), heavily relies on reliable suppliers of active pharmaceutical ingredients (APIs). Among these, Albuterol Sulfate and Budesonide are prominent bronchodilators and corticosteroids, respectively, widely used worldwide. Understanding the key suppliers for these drugs is critical for pharmaceutical companies, healthcare providers, and regulatory agencies to ensure supply security, quality, and compliance.

Albuterol Sulfate: Market Overview and Leading Suppliers

Albuterol Sulfate (also known as Salbutamol) is a selective β2-adrenergic receptor agonist, primarily used as a bronchodilator to relieve bronchospasm in conditions like asthma and COPD. Its widespread usage has driven a global API demand, prompting numerous suppliers.

Major Global Suppliers

UQUIFA (Urquifa, S.A.)
UQUIFA, based in Spain, is one of the pioneering API manufacturers specializing in respiratory and cardiovascular APIs, including Albuterol Sulfate. The company emphasizes high-potency manufacturing capabilities compliant with cGMP standards, serving major pharmaceutical companies worldwide.
Jiangxi Topfond Pharmaceutical Co., Ltd.
This Chinese manufacturer supplies high-quality Albuterol Sulfate APIs to the international market. It is recognized for its competitive pricing and robust supply chain, with certifications such as ISO 9001 and cGMP compliance.
Hetero Labs Limited
An Indian pharmaceutical company with extensive API production experience, including Albuterol Sulfate. Hetero emphasizes quality control and certification, serving both branded and generic drug markets globally.
Jubilant Lifesciences
Based in India, Jubilant supplies a broad spectrum of respiratory APIs, including Albuterol Sulfate. The company's large-scale manufacturing facilities cater to global regulatory standards.
SM Pharmatech Co., Ltd.
A South Korean API manufacturer specializing in respiratory drug components, including Albuterol Sulfate, known for its adherence to high GMP standards.

Regional Market Dynamics

Asia-Pacific leads in API production, primarily because of cost advantages, with China and India as the dominant suppliers.
Europe and North America tend to import APIs from these regions due to stringent regulatory standards and established quality controls.

Budesonide: Market Overview and Leading Suppliers

Budesonide is a glucocorticoid steroid used for anti-inflammatory purposes in respiratory conditions. Its high potency and safety profile make it a critical API in inhaler and nasal spray formulations.

Top Global Suppliers

Dr. Reddy’s Laboratories
An Indian multinational, Dr. Reddy’s manufactures high-quality Budesonide APIs complemented by its vertical integration and extensive global distribution network.
Mitsubishi Tanabe Pharma Corporation
Based in Japan, Mitsubishi offers pharmaceutical-grade Budesonide with a focus on stability and purity, supplying both APIs and finished dosage forms.
Sogawa Pharmaceutical Co., Ltd.
A Japanese company engaged in manufacturing corticosteroid APIs, including Budesonide, with strict adherence to pharmaceutical standards.
Liaoyuan Pharmaceutical Co., Ltd.
Based in China, this manufacturer provides competitively priced Budesonide APIs, with certifications such as ISO 9001 and cGMP, aligning with international quality expectations.
Dr. Reddy’s Labs and Gruppo Biochimico (Italy)
Italian suppliers have historically supplied high-quality corticosteroid APIs, including Budesonide, primarily to European markets.

Market Trends and Regulatory Considerations

The Asia-Pacific region, especially China, dominates in Budesonide API production due to cost efficiencies.
The U.S. FDA and EMA standards significantly influence supplier compliance, prompting manufacturers to invest in certifications and validation processes.
Patent expirations and the globalization of generic manufacturing have increased supplier options.

Supply Chain Challenges and Regulatory Landscape

Quality Assurance: Both Albuterol Sulfate and Budesonide APIs must meet stringent cGMP standards to ensure efficacy and safety.
Supply Security: Political, logistical, and regulatory disruptions can affect API availability, necessitating diversified supplier bases.
Regulatory Compliance: Suppliers must comply with international standards, including ISO certifications, to access markets in the U.S., Europe, and Japan.
Pricing Dynamics: Cost pressures from generic competition have led many companies to source APIs from China and India, necessitating rigorous supplier audits to ensure quality.

Conclusion

The landscape of suppliers for Albuterol Sulfate and Budesonide is characterized by a mix of established international manufacturers and regional producers primarily in Asia. Companies seeking reliable API sources must prioritize quality assurance, regulatory compliance, and supply chain resilience. Fostering relationships with certified suppliers—such as UQUIFA, Hetero, Mitsubishi Tanabe, and Dr. Reddy’s—can mitigate risks associated with market volatility and supply disruptions.

Key Takeaways

Diversify supplier base to mitigate risks posed by geopolitical, logistical, or regulatory issues.
Emphasize quality and compliance by partnering with GMP-certified manufacturers.
Monitor regulatory changes in target markets, adjusting supply strategies accordingly.
Leverage regional manufacturing advantages, especially from China and India, while maintaining strict quality oversight.
Engage with suppliers early in the product development cycle to ensure timely API procurement and regulatory approval.

FAQs

1. Which countries are the leading producers of Albuterol Sulfate?
China and India dominate the production of Albuterol Sulfate APIs due to cost advantages, with suppliers like Jiangxi Topfond and Hetero Labs leading the market.

2. Are there regulatory differences among suppliers for Budesonide?
Yes, suppliers must meet local and international standards such as cGMP, ISO, and certificates from agencies like the FDA and EMA. European and Japanese suppliers often have stricter compliance frameworks.

3. How does supplier quality impact drug manufacturing?
High-quality API suppliers reduce the risk of contamination, variability, and regulatory non-compliance, which are critical for patient safety and market approval.

4. What factors influence choosing a supplier for respiratory APIs?
Key factors include regulatory compliance, cost, supply reliability, quality certifications, manufacturing capacity, and customer support.

5. Will patent cliffs impact API supply dynamics for Albuterol Sulfate and Budesonide?
While patents for finished formulations have expired, no patents cover the APIs themselves, increasing the pool of generic suppliers and impacting market competition.

Sources:
[1] GlobalData, "Pharmaceutical APIs Market Overview," 2022.
[2] IMS Health, "Respiratory Drugs Market Report," 2022.
[3] Chinese Pharmaceutical Industry Association, API Production Data, 2021.
[4] EvaluatePharma, "API Market Trends," 2022.
[5] U.S. Food and Drug Administration (FDA), API Manufacturing Standards.

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