ondansetron hydrochloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	206846	ANDA	Accord Healthcare, Inc.	16729-298-05	20 mL in 1 VIAL (16729-298-05)	2016-10-20
Eugia Pharma	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	202599	ANDA	Eugia US LLC	55150-126-20	1 VIAL, MULTI-DOSE in 1 CARTON (55150-126-20) / 20 mL in 1 VIAL, MULTI-DOSE	2012-12-21
Fresenius Kabi Usa	ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	076974	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1377-1	20 mL in 1 VIAL (51662-1377-1)	2020-05-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Ondansetron hydrochloride is an antiemetic widely used to prevent nausea and vomiting caused by chemotherapy, radiation therapy, or post-operative conditions. Its clinical efficacy and safety profile have made it a flagship drug in oncology and post-surgical care. The global supply chain for ondansetron hydrochloride involves numerous pharmaceutical and chemical suppliers, ranging from active pharmaceutical ingredient (API) manufacturers to finished drug product producers. Understanding the landscape of these suppliers is critical for stakeholders seeking reliable sourcing, quality assurance, and cost-effectiveness in procurement strategies.

Global Manufacturing and Supply Landscape

API Suppliers

The backbone of ondansetron hydrochloride’s availability lies in high-quality API manufacturing. Major API suppliers include companies in India, China, Europe, and the United States, which are recognized for their manufacturing capabilities and regulatory compliance.

India
India remains a predominant hub for API manufacturing due to cost advantages and an established pharmaceutical ecosystem. Leading Indian API producers include:

Divi’s Laboratories
Recognized as a top-tier API manufacturer, Divi’s offers high-purity ondansetron hydrochloride APIs compliant with global regulatory standards. The company emphasizes quality control and scalability.
Laurus Labs
Laurus Labs supplies ondansetron hydrochloride APIs to both domestic and international markets, leveraging advanced synthesis processes and rigorous quality frameworks.
Fresenius Kabi India
A significant player in injectable pharmaceuticals, also providing ondansetron API, emphasizing sterility and compliance.

China
Chinese API manufacturers have expanded their footprint with competitive pricing and increasing regulatory compliance. Notable companies include:

North China Pharmaceutical Group Corporation (NPPC)
A leading producer of pharmaceutical intermediates and APIs, including ondansetron hydrochloride, with a focus on quality and export.
Shandong Xinhua Pharmaceutical
Known for synthesizing APIs with considerable scale, catering to global markets with a focus on cost competitiveness.

Europe & the US
While smaller in scale compared to India and China, European and US manufacturers emphasize stringent quality standards and regulatory compliance:

Catalent (US)
Provides high-quality APIs and contract manufacturing services, ensuring batch-to-batch consistency.
Rottapharm/Madaus (Italy)
Known for specialized pharmaceutical ingredients, including APIs for antiemetics, with high regulatory standards.

Finished Drug Product Suppliers

Once API production is secured, pharmaceutical companies focus on formulation, packaging, and distribution. Key players include:

Pfizer
Originally marketed ondansetron under the brand Zofran, with global manufacturing facilities ensuring wide market coverage.
Teva Pharmaceuticals
Offers generic versions with extensive manufacturing networks, often sourcing APIs from India and China.
Sanofi and Mundipharma
Also distribute ondansetron formulations across various regions.

Regulatory and Quality Considerations

Suppliers’ compliance with international regulatory standards such as the US FDA, European EMA, and WHO-GMP certifications significantly impact access to global markets. Buyers should evaluate:

Regulatory approvals: Ensuring the API or finished product meets the standards of target markets.
Quality certifications: GMP, ISO 9001, and other relevant certifications.
Traceability and documentation: Transparent supply chain records.
Supply security: Capacity to meet sustained demand without shortfalls.

Key Factors Influencing Supplier Selection

Regulatory compliance and quality assurance
Ensuring supplier adherence to GMP standards reduces risk of batch recalls and regulatory issues.
Cost competitiveness
Cost factors are heavily skewed towards India and China, though quality standards vary; procurement from high-quality suppliers can offset initial costs with reduced downstream risks.
Supply chain stability
Dependable suppliers with diversified manufacturing facilities mitigate risks related to geopolitical disruptions, raw material shortages, or capacity constraints.
Manufacturing capacity and scalability
Suppliers with scalable capabilities support fluctuating demand, particularly during global health crises like COVID-19.
Lead times and delivery reliability
Timely shipments are critical for uninterrupted clinical and commercial operations.

Emerging Trends and Future Outlook

Increasing regulatory scrutiny in China and India may challenge supplier flexibility but drive improvements in quality standards.
Supply chain localization initiatives in several regions could foster the development of regional API and finished product suppliers.
Technological advancements in synthesis methods, such as green chemistry, are being adopted by leading suppliers to improve sustainability.
Strategic collaborations and licensing agreements between global pharmaceutical giants and API manufacturers aim to ensure supply security and quality control.

Conclusion

The supply landscape for ondansetron hydrochloride is diverse, with prominent contributions from Indian and Chinese manufacturers for APIs, complemented by European and US firms emphasizing regulatory compliance and quality. Companies engaged in procurement must conduct rigorous due diligence, balancing cost, quality, and supply assurances to maintain uninterrupted access to this vital antiemetic. As supply chain dynamics evolve, maintaining strategic supplier relationships and monitoring regulatory developments remain vital for sustained procurement success.

Key Takeaways

Indian and Chinese API manufacturers dominate ondansetron hydrochloride supply, driven by cost and manufacturing capacity.
Ensuring suppliers meet international quality standards (GMP, FDA approvals) is crucial for regulatory compliance and patient safety.
Diversification of suppliers mitigates risks associated with geopolitical and supply disruptions.
Technological innovations and regulatory compliance will continue shaping the supply landscape.
Strategic partnerships and rigorous vetting processes optimize supply chain resilience and product quality.

Frequently Asked Questions

1. Who are the leading suppliers of ondansetron hydrochloride API globally?
Major API suppliers include Divi’s Laboratories and Laurus Labs in India, North China Pharmaceutical Group Corporation in China, and smaller regulatory-compliant manufacturers in Europe and the US.

2. How does regulatory compliance impact ondansetron hydrochloride suppliers?
Regulatory approval ensures manufacturers adhere to Good Manufacturing Practices (GMP), ensuring drug quality and enabling market access in strict jurisdictions like the US and EU.

3. What factors should companies consider when selecting an ondansetron hydrochloride supplier?
Consideration factors include regulatory compliance, quality certifications, supply reliability, capacity scalability, cost, and lead times.

4. Are there regional supply chain concerns for ondansetron hydrochloride?
Yes, geopolitical tensions, trade policies, or regional pandemic impacts can disrupt supply chains, prompting the need for diversified supplier bases.

5. What are the future trends in ondansetron hydrochloride supply?
Emerging trends include increased regulatory scrutiny, regional supply chain development, adoption of sustainable manufacturing methods, and greater collaborative licensing.

References

[1] Clarivate Analytics. “Active Pharmaceutical Ingredient (API) Market Analysis.” 2022.
[2] Indian Pharmaceutical Alliance. “API Manufacturing and Regulatory Landscape in India.” 2022.
[3] China Pharmaceutical Industry Association. “API Export and Regulatory Compliance Report.” 2022.
[4] U.S. FDA. “GMP Guidance for APIs.” 2023.
[5] European Medicines Agency. “Guidelines on Good Manufacturing Practices.” 2022.

Suppliers and packagers for generic pharmaceutical drug: ondansetron hydrochloride