Suppliers and packagers for serevent

serevent

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692	NDA	GlaxoSmithKline LLC	0173-0521-00	1 INHALER in 1 CARTON (0173-0521-00) / 60 POWDER, METERED in 1 INHALER	1997-11-25

Suppliers for the Pharmaceutical Drug: Serevent

Last updated: July 29, 2025

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Introduction

Serevent, the brand name for salmeterol, is a long-acting beta2-adrenergic receptor agonist (LABA) prescribed primarily for managing asthma and chronic obstructive pulmonary disease (COPD). Developed by GlaxoSmithKline (GSK), Serevent has been a cornerstone in respiratory therapy since its approval in the late 1990s. Its global distribution involves a complex supply chain consisting of multiple manufacturers, contract manufacturing organizations (CMOs), and distributors. This overview delves into key suppliers involved in the production and distribution of Serevent, emphasizing their roles, market positions, and strategic significance within the pharmaceutical supply ecosystem.

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Manufacturers and Contract Manufacturing Organizations (CMOs)

GlaxoSmithKline (GSK) – The Original Developer

GSK remains the primary innovator and marketer of Serevent, overseeing its formulation, regulatory compliance, and distribution. As a major pharmaceutical entity, GSK's extensive manufacturing network globally supports the production of Serevent's active pharmaceutical ingredient (API) and finished dosage forms. Their manufacturing sites are located across Europe, Asia, and North America, ensuring supply continuity to meet international demand.

API Suppliers for Salmeterol

The production of Serevent's API—salmeterol—is highly specialized, hinging on advanced chemical synthesis processes. Several chemical companies supply API intermediates or the final API to GSK and other contract manufacturers:

• Chinese API Manufacturers: China hosts multiple API producers capable of manufacturing salmeterol with high purity standards. Companies such as Zhejiang Hisun Pharmaceutical and Shanghai Sunwide Biotechnology have been identified as API suppliers or potential sources of salmeterol intermediates, benefiting from China's robust chemical manufacturing infrastructure.

• Indian API Suppliers: India's pharmaceutical industry is renowned for cost-effective API production. Firms like Cipla and Sun Pharmaceutical Industries have capabilities in respiratory API manufacturing, potentially serving as API suppliers for salmeterol.

• European API Manufacturers: Some European chemical manufacturers, including Evonik Industries and BASF, offer custom synthesis of complex APIs, possibly providing salmeterol or intermediates to GSK through contractual arrangements.

It is important to note that the specific API suppliers for GSK's Serevent are often not publicly disclosed due to commercial confidentiality and supply chain security.

Formulation and Final Dosage Manufacturing

Once the API is procured, formulation facilities—often operated by contract manufacturing organizations—combine the active ingredient with excipients to produce inhalation powder or aerosol forms. Several CMOs specializing in inhalation products support GSK:

• Vaccine and Respiratory Product Specialists: Companies such as Catalent and Patheon (a part of Thermo Fisher Scientific) provide inhalation manufacturing services, leveraging advanced aerosolization and filling technologies.

• Asian Contract Manufacturers: In regions like India and China, several CMOs possess capabilities in inhaler assembly, capsule filling, and packaging, supplying GSK’s global distribution network.

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Distribution and Supply Chain Players

Global Distributors and Wholesalers

Post-manufacture, Serevent reaches pharmacies, hospitals, and healthcare providers via a network of distributors:

• McKesson, Cardinal Health, and Owens & Minor: These major pharmaceutical distributors in the United States and globally handle the distribution of GSK’s respiratory portfolio, including Serevent. Their extensive logistics networks enable rapid delivery and inventory management.

• Regional Distributors: In emerging markets, local distribution companies partner with GSK or its regional affiliates, facilitating market-specific distribution.

Off-Patent and Generic Suppliers

As patent protections for Serevent (salmeterol) have expired in numerous jurisdictions (e.g., the US patent expired in 2016), generic manufacturers have entered the market:

• Indian and Chinese Generics: Companies such as Cipla, Mylan, and Teva produce generic salmeterol inhalers that are bioequivalent to Serevent, often at substantially lower prices.

• Market Impact: The entry of generics has increased supply options and reduced costs, influencing GSK's market share and strategic positioning.

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Regulatory and Licensing Considerations

Manufacturing and supply agreements for Serevent are subject to stringent regulatory standards governed by the FDA, EMA, and other agencies. Licensing arrangements with regional partners enable broader access but often involve strict quality assurance protocols, ensuring consistency regardless of the supplier.

GSK maintains a diversified supplier base to mitigate risks related to production disruptions, geopolitical factors, and regulatory changes. This approach ensures a robust and resilient supply chain capable of meeting global demand.

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Key Suppliers Summary

Component	Major Suppliers/Manufacturers	Region	Role
API (Salmeterol)	Zhejiang Hisun Pharmaceutical; Cipla; Evonik; BASF	China; India; Europe	API synthesis and supply
Formulation & Manufacturing	Catalent; Patheon; Contract manufacturers in India and China	Global	Final inhalation product manufacturing
Distribution	McKesson; Cardinal Health; Regional distributors	North America, Europe, Asia	Global product distribution
Generics	Cipla; Mylan; Teva	India, China	Off-patent generic salmeterol products

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Strategic Considerations for Stakeholders

• Supply Chain Resilience: Diversification of supplier sources, especially for APIs, mitigates risks associated with geopolitical tensions, supply disruptions, and quality issues.

• Regulatory Compliance: Maintaining compliance with evolving regulatory standards across markets is crucial for uninterrupted supply and market access.

• Cost Management: Engaging with emerging market suppliers offers cost advantages, though quality assurance remains paramount.

• Intellectual Property: Patents influence the timing and geographic availability of generic alternatives, impacting supply dynamics.

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Key Takeaways

• GSK remains the primary manufacturer, leveraging a global network for API procurement and inhalation product manufacturing.

• Multiple API suppliers, predominantly from China, India, and Europe, underpin Serevent’s supply chain, often under confidentiality agreements.

• The expiration of patents has facilitated increased entry of generic salmeterol products, broadening supply channels and impacting market pricing.

• Contract manufacturing organizations (CMOs) ensure scalable, compliant formulation and filling, particularly for inhalation products.

• Maintaining a diversified, compliant supply chain enables reliable distribution worldwide, essential for respiratory therapies like Serevent.

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FAQs

1. Who are the main API suppliers for Serevent (salmeterol)?
Major API suppliers include Chinese companies like Zhejiang Hisun Pharmaceutical, Indian firms such as Cipla, and European chemical manufacturers like Evonik. Specific supplier contracts are proprietary but collectively support global production needs.

2. Are generic versions of Serevent available?
Yes. Once the original patent expired in various regions (e.g., 2016 in the US), several generic manufacturers, including Cipla and Mylan, began producing bioequivalent salmeterol inhalers.

3. What role do CMOs play in the Serevent supply chain?
Contract manufacturing organizations assemble, fill, and package the final inhalation products, ensuring quality and compliance while enabling scalability to meet global demand.

4. How does patent expiry affect Serevent's supply and pricing?
Patent expiration allows generics entry, increasing supply options, driving competition, and often reducing prices. It also shifts some manufacturing to off-patent producers, expanding supply chain diversity.

5. What are the risks associated with Serevent’s supply chain?
Risks include supply disruptions from API shortages, geopolitical tensions affecting manufacturing locations, regulatory hurdles, and quality control issues. Diversification and stringent quality assurance mitigate these risks.

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References

1. GlaxoSmithKline. Serevent (salmeterol) Inhalation: Prescribing Information. 2022.
2. U.S. Food and Drug Administration. Patent and Exclusivity Data for Serevent. 2016.
3. GlobalData Pharma Intelligence. API Market Report, 2021.
4. IMS Health. Respiratory Drug Market Analysis, 2022.
5. Indian Pharmaceutical Industry Report, 2022.