ETOPOSIDE PHOSPHATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457	NDA	H2-Pharma, LLC	61269-410-20	1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2009-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Etoposide phosphate is a chemotherapeutic agent used primarily in the treatment of various malignancies, including lung cancer, testicular cancer, and lymphomas. As a water-soluble prodrug of etoposide, it offers certain pharmacokinetic advantages, facilitating intravenous administration with improved solubility profiles. Given its clinical significance, a robust supply chain comprising reputable manufacturers and suppliers is critical for ensuring consistent drug availability, regulatory compliance, and quality assurance. This report benchmarks leading suppliers of etoposide phosphate, analyzing their market presence, manufacturing capabilities, and strategic positioning within the pharmaceutical supply landscape.

Market Overview of Etoposide Phosphate

Etoposide phosphate is a specialty pharmaceutical ingredient predominantly distributed in North America, Europe, and parts of Asia. Key considerations for supplier selection include manufacturing capacity, regulatory adherence (e.g., FDA, EMA approvals), quality control standards (GMP), and the ability to meet global demand fluctuations. While the original innovator companies have primarily focused on branded formulations, several generic manufacturers and raw material suppliers have emerged to cater to market needs.

Leading Suppliers and Manufacturers

1. TEVA Pharmaceuticals

Profile & Capabilities
TEVA is a global leader in generic pharmaceuticals, offering a portfolio that spans neurodegenerative, respiratory, and anti-cancer agents. Their manufacturing facilities adhere to rigorous GMP standards, ensuring high-quality production of active pharmaceutical ingredients (APIs). TEVA supplies etoposide phosphate primarily through authorized distributors and directly to hospitals and pharmacies in multiple regions.
Market Position
As one of the most established generic API suppliers, TEVA's extensive distribution network ensures reliable supply chains for etoposide phosphate. Their manufacturing facilities are certified by the FDA and EMA, providing reassurance regarding regulatory compliance.
Regulatory & Quality Standards
GMP-certified facilities, with ongoing audits to ensure quality, potency, and purity standards.

2. Hikma Pharmaceuticals

Profile & Capabilities
Hikma is a multinational pharmaceutical company specializing in injectable drugs and APIs. Their focus includes oncology and supportive care therapeutics.
Supply Chain & Distribution
Hikma's API manufacturing site in the Middle East and Europe supports large-scale production of etoposide phosphate, mainly targeting markets in the Middle East, Africa, and Asia. They also supply finished dosage forms in certain territories.
Regulatory Standing
Their manufacturing facilities comply with international GMP standards, ensuring interoperability with global regulatory landscapes.

3. Fresenius Kabi

Profile & Capabilities
Known for sterile injectable formulations and APIs, Fresenius Kabi offers high-quality etoposide phosphate APIs to hospitals and pharmaceutical manufacturers worldwide.
Manufacturing & Quality Assurance
Their production facilities meet stringent global GMP and ISO standards. They supply both bulk APIs and finished products, emphasizing safety, efficacy, and consistency.

4. JHP Pharmaceuticals / NorthStar Medical Radioisotopes

Profile & Capabilities
Although primarily known for radiopharmaceuticals, JHP, now part of NorthStar Medical Radioisotopes, also supplies certain oncology API components, including etoposide phosphate, in specific regions.
Market Niche
Focused on niche markets with high specificity requirements, they serve hospitals and speciality pharmacies.

5. Sigmapharm Laboratories

Profile & Capabilities
This US-based API manufacturer offers a wide range of generic oncology APIs including etoposide phosphate.
Regulatory & Quality Standards
GMP compliance and ongoing batch testing ensure quality. They supply to pharmaceutical companies and contract manufacturers.

Emerging and Regional Suppliers

While large multinationals dominate, regional manufacturers in India, China, and Eastern Europe are crucial for meeting localized demand. Companies like Qingdao Biochem (China) and Sun Pharma (India) supply bulk APIs, including etoposide phosphate, often at competitive prices. Certification and quality vary, underscoring the importance of validating suppliers through audits and quality documentation.

Supply Chain Challenges and Risks

Regulatory Variability: Suppliers differ in compliance levels, impacting ability to export to highly regulated markets such as the US and EU.
Manufacturing Capacity Fluctuations: The COVID-19 pandemic highlighted vulnerabilities in supply chains, causing delays and shortages.
Quality Concerns: Variability in GMP adherence can affect drug safety and efficacy; rigorous supplier qualification processes are essential.
Price Volatility: Raw material costs and geopolitical stability influence pricing, necessitating diversified supplier sourcing.

Strategic Sourcing Recommendations

Conduct thorough due diligence on suppliers’ regulatory standing and GMP accreditation.
Favor suppliers with diversified manufacturing sites to mitigate regional disruption risks.
Engage with suppliers that have a proven track record in delivering consistent, high-quality etoposide phosphate.
Establish terms for supply continuity, including contingency plans and inventory management strategies.

Conclusion

The complex landscape of etoposide phosphate supply manifests predominantly through well-established global players such as TEVA, Hikma, and Fresenius Kabi, alongside regional manufacturers in Asia and Eastern Europe. Ensuring a resilient supply chain requires strategic supplier qualification, rigorous quality assurance protocols, and ongoing monitoring of regulatory compliance. As the demand for oncology therapeutics surges, fostering strong supplier relationships and diversifying procurement channels will be pivotal for pharmaceutical companies seeking stability and quality in sourcing etoposide phosphate.

Key Takeaways

Leading global suppliers include TEVA, Hikma, and Fresenius Kabi, with established GMP compliance.
Regional manufacturers in China and India play vital roles in meeting local demand but require thorough vetting.
Regulatory and quality standards are paramount; GMP certification ensures product safety and efficacy.
Supply chain risks necessitate diversification, contingency planning, and proactive supplier audits.
Strategic sourcing enhances resilience, quality assurance, and overall supply stability for etoposide phosphate.

FAQs

1. What criteria should I consider when selecting a supplier for etoposide phosphate?
Prioritize GMP certification, regulatory compliance (FDA, EMA approvals), manufacturing capacity, quality control protocols, and supply reliability.

2. Are there regional suppliers for etoposide phosphate in Asia?
Yes, numerous Chinese and Indian manufacturers produce the API, often at competitive prices; however, validation of quality standards is critical.

3. How does regulatory compliance impact the procurement process?
Regulatory compliance ensures the product meets safety, efficacy, and quality standards necessary for international markets, reducing legal and safety risks.

4. Can I rely solely on a single supplier for etoposide phosphate?
No, diversification mitigates risks associated with supply disruptions, quality issues, or regulatory challenges.

5. What are the future trends in the supply of etoposide phosphate?
Increasing demand for biosimilar and innovative formulations could reshape supply chains, emphasizing quality control advancements and supply chain transparency.

Sources

[1] MarketsandMarkets, "Oncology Drugs Market," 2022.
[2] U.S. FDA Database, "Approved APIs and Suppliers," 2023.
[3] IQVIA, "Pharmaceutical Supply Chain Report," 2022.
[4] TEVA Pharmaceuticals official website.
[5] Hikma Pharmaceuticals official website.

Suppliers and packagers for generic pharmaceutical drug: ETOPOSIDE PHOSPHATE