Suppliers and packagers for zaleplon

zaleplon

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-505-30	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30)	2008-06-06
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	Rising Pharma Holdings, Inc.	57237-239-01	100 CAPSULE in 1 BOTTLE (57237-239-01)	2008-06-06
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	Rising Pharma Holdings, Inc.	57237-240-01	100 CAPSULE in 1 BOTTLE (57237-240-01)	2008-06-06
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	Aurobindo Pharma Limited	65862-214-01	100 CAPSULE in 1 BOTTLE (65862-214-01)	2008-06-06
Aurobindo Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	078829	ANDA	Aurobindo Pharma Limited	65862-214-05	500 CAPSULE in 1 BOTTLE (65862-214-05)	2008-06-06

Suppliers for the Pharmaceutical Drug: Zaleplon

Last updated: July 27, 2025

Introduction

Zaleplon, marketed under brands such as Sonata, is a non-benzodiazepine hypnotic agent primarily prescribed for the short-term management of insomnia. Its rapid onset and short half-life make it suitable for helping patients fall asleep without significant residual sedation. Given its widespread use, the supply chain for zaleplon involves a complex network of active pharmaceutical ingredient (API) manufacturers, formulation producers, and distribution channels. This article explores key suppliers, manufacturing trends, and market implications for zaleplon, providing valuable insights for industry stakeholders.

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Manufacturers of Zaleplon API

Global API Suppliers

The core of zaleplon’s supply chain begins with the production of its active pharmaceutical ingredient. Several pharmaceutical companies and contract manufacturing organizations (CMOs) globally manufacture zaleplon API, predominantly sourced from China, India, and some European countries.

Chinese Manufacturers

China remains a dominant force in API production across various classes, including sedative-hypnotics like zaleplon. Several Chinese pharmaceutical firms have established extensive API manufacturing facilities compliant with Good Manufacturing Practices (GMP). Companies such as Zhejiang Hisun Pharmaceutical Co., Ltd. and Tianjin Zhongxin Pharmaceutical Group Co., Ltd. are known for producing APIs in this category.

Indian Suppliers

India’s pharmaceutical sector, bolstered by a robust CMO industry, supplies zaleplon API both domestically and for export. Manufacturers like Dr. Reddy’s Laboratories and Aurobindo Pharma have capabilities to produce this API, often offering cost-effective options with reliable quality standards. These firms benefit from India’s extensive pharmaceutical infrastructure and compliance with global standards.

European and U.S. Suppliers

While less prevalent, some European and U.S.-based CMOs and chemical suppliers offer sterile and high-purity zaleplon API, primarily serving specialized or regulated markets. These suppliers often provide higher quality assurance, particularly for markets with stringent regulatory requirements, including the U.S. FDA and EMA.

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Formulation and Finished Dosage Form Manufacturers

Post API acquisition, zaleplon is formulated into capsules predominantly for the global market. Major pharmaceutical firms and generic drug manufacturers play critical roles in this segment.

Brand Name and Generic Manufacturers

• Sanofi: The original innovator for Sonata in the early 1990s, Sanofi has historically been involved in the formulation, marketing, and distribution of zaleplon under the brand name Sonata.

• Teva Pharmaceutical Industries: A leading generic manufacturer supplying zaleplon capsules in multiple markets, leveraging APIs sourced from Asian suppliers.

• Mylan (now part of Viatris): Offers generic zaleplon formulations, often utilizing APIs from Chinese and Indian manufacturers.

• Alkem Laboratories and Natco Pharma: Indian pharmaceutical companies that manufacture and distribute generic zaleplon globally, often partnering with API suppliers from Asia.

Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource formulation and final product manufacturing to CMOs specializing in capsule manufacturing, such as Samsung BioLogics and Laurus Labs, ensuring compliance with regulatory standards and facilitating market access.

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Market Trends and Supply Chain Dynamics

Geopolitical Factors

The reliance on Chinese and Indian API suppliers exposes zaleplon’s supply chain to geopolitical risks, including trade tensions and regulatory clampdowns. Recent US-China trade disputes have prompted some companies to diversify sources, increasing interest in European or North American API manufacturing.

Regulatory Compliance and Quality Assurance

Quality assurance is paramount, especially given zaleplon’s classification as a controlled substance (Schedule IV in the U.S. and similar jurisdictions). Suppliers must comply with stringent GMP standards, with regulatory approvals often dictating supplier choice for marketed formulations.

Supply Chain Consolidation and Diversification

Consolidation among API manufacturers has led to fewer suppliers but increased reliability in quality and delivery. Conversely, some companies seek to diversify sourcing to mitigate risks, create competitive pricing, and adhere to regional regulations.

Impact of COVID-19

The COVID-19 pandemic disrupted global supply chains, affecting raw material availability, logistics, and manufacturing capacities. Consequently, pharmaceutical companies accelerated efforts to establish domestic APIs and more resilient supply networks for sedative agents like zaleplon.

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Key Suppliers and Their Market Share

Supplier Category	Notable Companies	Geographic Focus	Market Role
API Manufacturers	Zhejiang Hisun, Tianjin Zhongxin, Dr. Reddy’s, Aurobindo	China, India	API supply, bulk production
Formulation & Final Dosage	Sanofi, Teva, Mylan, Alkem	Global	Capsule formulation, distribution
Contract Manufacturing	Samsung BioLogics, Laurus Labs	South Korea, India	Finished product manufacturing

Note: Exact market share data remains proprietary; however, Asian manufacturers dominate API supplies, with European and North American firms serving niche markets and high-regulation segments.

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Implications for Industry Stakeholders

Pharmaceutical Companies

Procurement professionals must evaluate supplier credibility, regulatory compliance, and geopolitical considerations when sourcing zaleplon API. Diversification strategies enhance supply security amid fluctuating geopolitical landscapes.

Investors and Market Analysts

The dependency on Asian API suppliers presents risks and opportunities. Companies that successfully diversify or vertically integrate API production may gain competitive advantages, impacting zaleplon’s pricing and availability.

Regulators

Enforcement of quality standards and transparency in the supply chain remain critical. Ensuring API traceability and GMP compliance mitigates risks of adulteration or substandard products reaching consumers.

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Conclusion

The supply landscape for zaleplon hinges on a robust network of API and formulation manufacturers predominantly located in Asia, with growing efforts toward diversification due to geopolitical and logistical challenges. For entities involved in zavlpeon’s distribution and manufacturing, understanding the nuances of supplier reliability, quality assurance, and regulatory compliance is vital for maintaining market stability.

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Key Takeaways

• Asia dominates zaleplon API production, with China and India as primary suppliers, though geopolitical risks are prompting diversification.

• Formulations are predominantly supplied by major global generic manufacturers like Teva and Mylan, leveraging Asian API sources.

• Regulatory standards govern sourcing decisions, emphasizing GMP compliance and quality assurance.

• Supply chain resilience is increasingly critical, especially post-pandemic, with companies seeking to mitigate risks through diversification.

• Monitoring geopolitical and regulatory developments informs procurement and strategic planning for zaleplon-market stakeholders.

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FAQs

1. Who are the primary API suppliers for zaleplon globally?
   The leading API suppliers are Chinese firms such as Zhejiang Hisun Pharmaceutical and Tianjin Zhongxin Pharmaceutical Group, alongside Indian manufacturers like Dr. Reddy’s and Aurobindo Pharma.

2. Are there domestic API producers for zaleplon in the United States or Europe?
   While some GMP-compliant European and North American firms produce zaleplon API, they constitute a small fraction compared to Asian suppliers, with most sourcing occurring from China and India.

3. How does geopolitical tension affect the supply chain of zaleplon?
   Geopolitical tensions can lead to trade restrictions, tariffs, and regulatory scrutiny, prompting companies to diversify sources or establish local manufacturing capabilities to ensure supply continuity.

4. What roles do CMOs play in zaleplon manufacturing?
   CMOs handle formulation, capsule filling, and final product manufacturing, often sourcing API from primary API suppliers, thus acting as a critical link in the supply chain.

5. What are the regulatory considerations when sourcing zaleplon?
   Suppliers must comply with GMP standards; regulatory authorities such as the FDA and EMA monitor the quality, origin, and manufacturing processes of APIs, influencing procurement choices.

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References

[1] Pharmaceutical News. "API Manufacturing Trends in Sedative-Hypnotics." PharmaChem Weekly, 2022.
[2] U.S. Food and Drug Administration (FDA). "Guidance for Industry: Good Manufacturing Practice (GMP) Regulations." 2021.
[3] MarketWatch. "Generic Sedative Market Report." 2023.
[4] Asia-Pacific Pharmaceutical Industry Report, 2022.
[5] International Narcotics Control Board. "Regulations and Control of Controlled Substances," 2022.