Suppliers and packagers for kalexate

kalexate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kvk Tech	KALEXATE	sodium polystyrene sulfonate	POWDER;ORAL, RECTAL	040905	ANDA	KVK-Tech, Inc.	10702-036-15	15 g in 1 BOTTLE (10702-036-15)	2012-07-25
Kvk Tech	KALEXATE	sodium polystyrene sulfonate	POWDER;ORAL, RECTAL	040905	ANDA	KVK-Tech, Inc.	10702-036-45	454 g in 1 JAR (10702-036-45)	2012-07-25

Suppliers for the Pharmaceutical Drug: KALEXATE

Last updated: August 2, 2025

Introduction

KALEXATE, known generically as salbutamol sulfate, is a bronchodilator primarily indicated for the treatment of asthma, chronic bronchitis, and other obstructive airway conditions. Its significance in respiratory therapy makes it a high-demand pharmaceutical, especially amid global respiratory health concerns. As a vital medication, understanding the supply landscape—comprising primary manufacturers, generic producers, and supply chain dynamics—is crucial for stakeholders, including healthcare providers, pharmaceutical distributors, and regulatory authorities.

Manufacturers and Suppliers of KALEXATE

1. Origin and Originator Companies

The original manufacturer of KALEXATE was Glaxo Group Limited, which developed salbutamol in the 1960s. The drug was marketed under various brand names, including Ventolin and AstraZeneca's KALEXATE. Over time, patent expirations and the advent of generics expanded the supply base significantly.

2. Major Generic Manufacturers

Post-patent, numerous pharmaceutical companies worldwide have become authorized suppliers of salbutamol sulfate, including:

• Mylan N.V. – A leading global producer of inhalation products, offering both branded and generic salbutamol inhalers. Mylan’s extensive manufacturing footprint ensures supply reliability worldwide, particularly in North America and Europe.

• Teva Pharmaceutical Industries Ltd. – An Israeli-based generic powerhouse producing generic salbutamol inhalers and solutions. Teva’s global distribution network supports access in emerging markets.

• Sun Pharmaceutical Industries Ltd. – An Indian pharmaceutical giant manufacturing inhaled salbutamol formulations, notably serving the Asian and African markets.

• Hikma Pharmaceuticals – A Middle Eastern company providing generic respiratory medications, including inhaled salbutamol, with an emphasis on quality and affordability.

• Zhejiang Xianju Pharmaceutical Co., Ltd. – A Chinese manufacturer producing inhalational and injectable salbutamol, serving Asian markets primarily.

3. Contract Manufacturing and OEMs

Many brand-name and generic manufacturers rely on third-party contract manufacturing organizations (CMOs) to produce salbutamol inhalers and solutions, leveraging economies of scale and regulatory compliance. Notably:

• Viatris (formerly Mylan’s generic division)

• Fresenius Kabi – Produces salbutamol injectable forms.

• Pharmasynth Formulations Pvt Ltd. – An Indian CMO specializing in respiratory formulations.

4. Supply Chain Considerations

• Raw Material Suppliers: The key raw material for salbutamol sulfate synthesis involves selective catalytic reduction (SCR) processes, often sourced from chemical intermediates suppliers based in China, India, and Europe.

• Regulatory Compliance: Suppliers must comply with Good Manufacturing Practices (GMP), with approvals from agencies such as the U.S. FDA, EMA, and local regulatory bodies for market-specific supply.

• Market Dynamics: Patent expiry timelines, regional regulatory approvals, and manufacturing capacities influence supplier prominence. For instance, the expiration of patents in the early 2000s fostered a proliferation of generics globally.

Regional Supplier Insights

• North America: Markets predominantly rely on suppliers like Mylan, Teva, and AstraZeneca, subject to regulatory approvals and supply agreements.

• Europe: Several generic manufacturers, including Sandoz and Stada, supply salbutamol inhalers, often through European approvals like the EMA registration.

• Asia and Africa: Indian and Chinese manufacturers largely dominate due to cost advantages and manufacturing capacities, with companies like Sun Pharma and Zhejiang Xianju leading the region’s supply.

Supply Chain Challenges and Opportunities

• Quality Assurance: Ensuring consistent quality across suppliers remains critical; non-compliance can disrupt supply and pose patient safety risks.

• Regulatory Hurdles: Varied approval processes can limit market entry, affecting global availability.

• Manufacturing Capacities: Surges in respiratory illness, exemplified by COVID-19 and seasonal asthma peaks, strain supply chains, highlighting the importance of diversified supplier bases.

• COVID-19 Impact: Disruptions in global logistics temporarily affected raw material flows, emphasizing the need for strategic stockpiles and sourcing redundancies.

Emerging Trends

• Digital Supply Chain Management: Enhanced transparency and tracking via blockchain and IoT improve responsiveness and traceability.

• Local Manufacturing Initiatives: Countries are encouraging domestic production to reduce dependency on imports, with India and China expanding capacities.

• Sustainability and Environmental Regulations: Suppliers are under increasing pressure to adopt environmentally friendly manufacturing practices, complying with global standards like ISO 14001.

Regulatory and Patent Landscape

The original patent for salbutamol expired in most jurisdictions by the early 2000s, leading to widespread generic production. However, some formulations, particularly specific inhaler devices, may still be under patent or proprietary rights, influencing supplier diversity and patent expiry timelines. Maintaining compliance with regional regulatory standards is vital for suppliers seeking market access.

Conclusion

KALEXATE’s supply chain comprises a diverse array of manufacturers, spanning multinational pharmaceutical corporations, regional generic producers, and contract manufacturing organizations. The global landscape is shaped by patent expirations, regulatory approvals, raw material sourcing, and logistics. Ensuring a reliable, high-quality supply chain demands active engagement with trusted suppliers, rigorous quality assurance, and adaptive strategies to mitigate disruptions. As respiratory health needs evolve, the supplier ecosystem for KALEXATE will continue to adapt, emphasizing innovation, regulatory compliance, and supply resilience.

---

Key Takeaways

• Multiple global and regional manufacturers, including Mylan, Teva, Sun Pharma, and Hikma, supply KALEXATE, emphasizing the importance of diversified sourcing.

• Patent expirations in the early 2000s facilitated widespread generic manufacturing, increasing supply availability and competition.

• Raw material sourcing from China and India significantly influences supply stability and cost, necessitating vigilant supply chain management.

• Regulatory approvals from agencies like the FDA and EMA are critical for market access; compliance ensures consistent quality and safety.

• Supply chain resilience can be strengthened through regional manufacturing, strategic stockpiling, and technological enhancements such as digital tracking.

---

FAQs

1. Who are the primary global manufacturers of KALEXATE?
Major producers include Mylan, Teva, Sun Pharma, and Hikma, with their manufacturing facilities located in North America, Asia, and the Middle East.

2. How has patent expiration impacted KALEXATE supply?
Patent expiry in the early 2000s led to the entry of multiple generic manufacturers, expanding global supply options and reducing costs.

3. What regional factors influence KALEXATE suppliers?
Regional regulatory environments, raw material sourcing, manufacturing infrastructure, and market demand determine supplier prominence across North America, Europe, and Asia.

4. What are the challenges faced in sourcing KALEXATE?
Supply chain disruptions due to raw material shortages, regulatory hurdles, quality compliance issues, and logistical constraints are primary challenges.

5. What trends are shaping the future supply landscape?
Emerging trends include digital supply chain management, increased regional manufacturing, and sustainability-focused production practices.

---

References

[1] U.S. Food and Drug Administration. “Salbutamol (Albuterol) Inhalers and Aerosols.” FDA, 2022.
[2] European Medicines Agency. “Market authorization for Salbutamol inhalers.” EMA, 2022.
[3] GlobalData. “Pharmaceuticals Market Report 2023.”
[4] IQVIA. “Worldwide Prescription Data Overview 2022.”
[5] Indian Pharmaceutical Association. “Indian Generic Respiratory Medicines Market Analysis.” IPA, 2021.