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Suppliers and packagers for etoposide
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etoposide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan | ETOPOSIDE | etoposide | CAPSULE;ORAL | 075635 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3266-94 | 20 CAPSULE in 1 CARTON (0378-3266-94) | 2001-10-22 |
| Accord Hlthcare | ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074513 | ANDA | Accord Healthcare Inc. | 16729-114-08 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-08) / 25 mL in 1 VIAL, MULTI-DOSE | 2015-03-03 |
| Accord Hlthcare | ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074513 | ANDA | Accord Healthcare Inc. | 16729-114-11 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-11) / 50 mL in 1 VIAL, MULTI-DOSE | 2015-03-03 |
| Accord Hlthcare | ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074513 | ANDA | Accord Healthcare Inc. | 16729-114-31 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-31) / 5 mL in 1 VIAL, MULTI-DOSE | 2015-03-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ETOPOSIDE
Last updated: January 8, 2026
Summary
Etoposide is a chemotherapeutic agent used primarily for treating various cancers, including lung, testicular, and lymphoma. Due to its widespread clinical application, a broad network of suppliers exists globally. This report provides an authoritative overview of etoposide suppliers, analyzing key manufacturers, regional distribution, manufacturing specifications, and regulatory considerations. It aims to inform pharmaceutical companies, healthcare providers, and investors about the current landscape of etoposide sourcing, highlighting market dynamics, quality standards, and supply chain security.
What Are the Main Suppliers of Etoposide Globally?
Major Pharmaceutical Manufacturers
| Company | Country | Type | Products/Brands | Notes |
|---|---|---|---|---|
| Bristol-Myers Squibb (BMS) | USA | Fully branded supplier | Etopophos®, VePesid® | Original patent holder; shifted to generics post-patent expiry |
| Pfizer | USA | Generics/Manufacturers | Multiple generics via authorized and third-party manufacturers | Engages in licensing arrangements for generic production |
| Teva Pharmaceutical Industries | Israel | Generics | Etoposide tablets and injections | One of the largest generic drug producers |
| Sandoz (Novartis Group) | Switzerland | Generics | Etoposide formulations | Extensive distribution network |
| Hetero Drugs Ltd. | India | Generics | Etoposide injections and capsules | Noted for low-cost manufacturing |
| Cipla Ltd. | India | Generics | Etoposide formulations | Known for accessibility in emerging markets |
| Gland Pharma | India | Generics | Etoposide injections | Focus on high-quality injectables |
Regional Focus in Supply Chains
| Region | Major Suppliers | Market Dynamics |
|---|---|---|
| United States | BMS (original), Pfizer, Teva | High regulatory standards favor quality; patent expiry ≈2002 |
| Europe | Sandoz, Teva, biosimilar suppliers | Emphasis on compliance, growing generic penetration |
| India | Hetero, Cipla, Gland Pharma, Sun Pharma | Cost-effective manufacturing; significant export hub |
| China | Local generic manufacturers, joint ventures | Growing capacity; regulatory environment improving |
| Other markets | Egypt, Brazil, South Africa | Emerging markets with increasing access to generics |
Manufacturing Specifications & Quality Standards
Production Protocols
| Parameter | Details |
|---|---|
| Active Pharmaceutical Ingredient (API) | Etoposide used in capsules and injections, synthesized via standardized chemical processes |
| API Purity Standards | Typically >99% purity (USP or EP standards) |
| Formulations | Oral capsules, injectable solutions |
| Manufacturing Sites | Facilities compliant with Good Manufacturing Practices (GMP), certified by regulatory agencies such as FDA, EMA, WHO |
Regulatory Compliance
| Regulatory Bodies | Standards & Approvals | Implications for Suppliers |
|---|---|---|
| FDA (USA) | 21 CFR Part 210, 211, 310 | Requires rigorous validation, stability testing |
| EMA (Europe) | EudraLex, CCM (chemical, manufacturing standards) | Good Manufacturing Practice (GMP) compliance required |
| WHO | Prequalification program for generics | Certification essential for global distribution |
| Indian Pharmacopeia (IP) | Specific purity and quality standards | Many Indian suppliers adhere to IP standards |
Market Dynamics & Supply Chain Considerations
Supply Chain Drivers
- Patent Expiry & Generics Boom: Etoposide's patent expired around 2002, leading to a proliferation of generic manufacturers.
- Regulatory Approvals: Stringent approval processes influence availability, especially for injectable forms.
- Manufacturing Capacity: Increasing capacities in India and China meet rising global demand.
- Pricing & Cost Factors: Cost-effective production in emerging markets enhances global accessibility.
- Supply Security Risks: Quality issues, geopolitical disruptions, and regulatory variances pose risks.
Key Supply Chain Challenges
- Quality Assurance: Ensuring API purity and formulation stability.
- Regulatory Compliance: Navigating varying standards across jurisdictions.
- Supply Disruptions: Political, natural disasters, or manufacturing issues.
- Pricing Pressure: Market commoditization leads to squeezing profit margins.
Comparison of Suppliers: Strengths & Weaknesses
| Supplier | Strengths | Weaknesses | Certifications |
|---|---|---|---|
| Bristol-Myers Squibb (BMS) | Original innovator, robust quality | Higher pricing | FDA, EMA, WHO prequalified |
| Pfizer | Extensive global reach, large capacity | Focus more on generics globally | GMP, ISO certifications |
| Teva | Cost-competitiveness, large API sourcing | Quality variations due to scale | GMP, USFDA approval |
| Sandoz | Strong in Europe, quality focus | Less presence in emerging markets | EMA, USFDA, WHO |
| Hetero, Cipla, Gland Pharma | Low-cost production, growing capacity | Variable quality control | Indian pharmacopeia standards |
Supply Chain Outlook & Future Trends
| Trend | Implication |
|---|---|
| Increasing generic competition | Continuing price decline, focus on quality differentiation |
| Regulatory harmonization | Streamlining approval processes, expanding global access |
| API manufacturing globalization | Diversification to mitigate geopolitical risks |
| Innovation in formulations | Possible development of novel delivery mechanisms |
| Growth in emerging markets | Increased demand for affordable chemotherapy drugs |
Key Regulatory Policies Influencing Suppliers
| Policy/Guideline | Issuing Entity | Impact on Suppliers |
|---|---|---|
| FDA's Drug Quality and Security Act | FDA | Stringent requirements for API and finished product quality |
| EMA Guidelines on Manufacturing | EMA | Emphasis on GMP, stability, and efficacy standards |
| WHO Prequalification Program | WHO | Certification for global distribution, especially in low-income countries |
| Indian Pharmacopoeia Standards | Indian Government | Sets quality benchmarks for domestic and export markets |
Comparison: Branded vs. Generic Suppliers
| Category | Branded (e.g., BMS) | Generics (e.g., Teva, Cipla) |
|---|---|---|
| Market Share | Lower post-patent expiry | Dominates due to cost advantage |
| Price Point | Higher | Significantly lower |
| Quality Assurance | Typically higher, more rigorous | Variable; reliant on GMP adherence |
| Market Focus | Niche, specialized markets | Mass-market, global distribution |
FAQs on Etoposide Suppliers
1. Who are the leading global suppliers of etoposide?
Major global suppliers include Bristol-Myers Squibb (original patent holder), Pfizer, Teva, Sandoz, and prominent Indian manufacturers such as Hetero, Cipla, and Gland Pharma.
2. What regulatory certifications should suppliers of etoposide possess?
Suppliers should have GMP certification from authorities such as the USFDA, EMA, or local agencies like the Indian Drugs Controller General (DCGI). WHO prequalification is essential for global procurement, especially in low-income or emergency contexts.
3. Are there regional differences in etoposide supply quality standards?
Yes. North American and European markets generally enforce stricter standards, requiring FDA or EMA approval. Indian and Chinese manufacturers primarily adhere to local pharmacopeia standards, though many export globally after obtaining international certifications.
4. What are the risks associated with reliance on a limited number of suppliers?
Dependence may lead to supply shortages, quality variability, or geopolitical risks. Diversification across multiple reputable suppliers mitigates these risks.
5. How is supply chain transparency maintained for etoposide?
Through traceability systems, rigorous supplier qualification processes, GMP audits, and compliance with international standards like ICH Q7 for API manufacturing.
Key Takeaways
- The etoposide supply chain is dominated by a mix of original patent holders (BMS) and a broad global generic manufacturer base.
- Indian manufacturers such as Hetero and Cipla play a significant role in supplying affordable etoposide, especially for emerging markets.
- Regulatory compliance (GMP, WHO prequalification) is critical for assuring quality and ensuring global market access.
- Supply chain risks can be mitigated by diversification, rigorous supplier qualification, and establishing buffer stock.
- Future trends include increased manufacturing capacity in China and India, regulatory harmonization, and possible innovations in formulation.
References
- U.S. Food and Drug Administration (FDA). Drug master file: Etoposide. FDA.gov, 2022.
- European Medicines Agency (EMA). Guidelines on good manufacturing practice. EMA.europa.eu, 2022.
- WHO Prequalification Programme. Pharmaceutical prequalification for high-quality medicines. WHO.int, 2022.
- Indian Pharmacopeia Commission. Standards for etoposide. IP India, 2022.
- Market Data & Industry Reports. Global Oncology Drugs Market Analysis Report, 2022.
(Note: All data points and references are current as of 2023. For procurement or strategic decisions, verify with up-to-date sources and regulatory filings.)
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