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Suppliers and packagers for ETOPOPHOS PRESERVATIVE FREE
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ETOPOPHOS PRESERVATIVE FREE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers for the Pharmaceutical Drug: ETOPOPHOS PRESERVATIVE FREE
Introduction
Etopophos Preservative Free (Etoposide Phosphate for Injection) is an essential chemotherapeutic agent used predominantly in the treatment of various cancers, including testicular cancer, lung cancer, lymphoma, and leukemia. As a preservative-free formulation designed to reduce hypersensitivity reactions, its supply chain is critical for healthcare providers requiring high-purity, sterile pharmaceutical-grade solutions. This article explores the primary suppliers manufacturing Etopophos Preservative Free, examining their market presence, manufacturing capabilities, and distribution networks to aid stakeholders in sourcing and strategic planning.
Overview of Etopophos Preservative Free
Etopophos Preservative Free is a sterile, pyrogen-free, preservative-free phosphate ester form of etoposide, delivered as a solution for intravenous administration. Its preservative-free formulation enhances tolerability and minimizes adverse allergic reactions, a significant advantage over traditional etoposide formulations containing preservatives. Due to its complexity and stringent regulatory requirements, manufacturing and supply are limited to specialized pharmaceutical firms with advanced sterile processing facilities.
Key Suppliers of Etopophos Preservative Free
1. Pfizer Inc.
Market Position
Pfizer is the original manufacturer of Etopophos, branded as Etopophos Preservative Free. As a global pharmaceutical leader, Pfizer's extensive manufacturing infrastructure and quality assurance systems ensure consistent supply of this chemotherapeutic agent.
Manufacturing and Distribution
Pfizer’s manufacturing sites adhere to Good Manufacturing Practices (GMP) internationally, primarily in the United States and Europe. The company maintains a robust distribution network ensuring availability across North America, Europe, and select Asia-Pacific markets.
Regulatory Status
Pfizer’s Etopophos Preservative Free is approved by major regulators, including the FDA and EMA. Its status as an established product provides confidence in supply stability for healthcare providers worldwide.
2. Teva Pharmaceutical Industries Ltd.
Emerging Competitor
Teva, a prominent generic pharmaceutical company, supplies preservative-free etoposide formulations. While primarily recognized for generic versions, Teva’s expertise in sterile injectables allows it to capitalize on the demand for preservative-free chemotherapeutics.
Manufacturing Capabilities
Located predominantly in Israel and the United States, Teva’s manufacturing plants meet stringent GMP standards, ensuring high-quality sterile injectables. Its global supply network enables distribution to North America, Europe, parts of Asia, and Latin America.
Product Portfolio
Teva offers a preservative-free etoposide solution under its generic label, often positioned as a cost-effective alternative where Pfizer’s product isn't available or is cost-prohibitive.
3. Sandoz (Novartis)
Specialization
Sandoz manufactures various sterile injectables, including chemotherapeutic agents like etoposide phosphate. Their focus on biosimilars and sterile injectables makes them a key player for preservative-free formulations.
Manufacturing and Distribution
Operates multiple sterile manufacturing facilities aligned with GMP in Europe and North America. Sandoz’s extensive distribution channels serve major markets, including the U.S., Europe, and emerging markets in Asia and Africa.
4. Sun Pharmaceutical Industries Ltd.
Regional Focus
Sun Pharma supplies etoposide phosphate, including preservative-free injectable forms, particularly targeting the Indian and Southeast Asian markets.
Manufacturing and Quality
With manufacturing sites approved by the Food and Drug Administration (FDA) and Parliament's Central Drugs Standard Control Organization (CDSCO), Sun Pharma ensures compliance with international standards.
Market Presence
While primarily serving domestic and regional markets, Sun Pharma’s aggressive pricing and increased export focus are gradually expanding its global footprint.
5. Other Notable Suppliers
- Hovione Fine Chemistry: Specializes in custom synthesis and sterile formulations, potentially supplying bulk active pharmaceutical ingredients (APIs) or finished products under contract manufacturing agreements.
- Cipla Ltd.: An Indian pharmaceutical company involved in producing generic chemotherapeutics, including etoposide formulations, with a growing presence in global markets.
Market Dynamics and Considerations
Supply Chain Challenges
The production of preservative-free etoposide phosphate demands advanced sterile manufacturing facilities, resulting in limited suppliers. Supply chain disruptions can occur due to regulatory hurdles, raw material shortages, or manufacturing delays, impacting oncology treatment continuity.
Global Regulatory Landscape
Regulatory authorities rigorously scrutinize sterile injectable products, necessitating continuous compliance for suppliers. Changes in regulations or quality standards may impact manufacturing licenses and distribution.
Pricing and Access
Pricing variability exists among suppliers, influenced by manufacturing costs, regional regulations, and patent status. While Pfizer’s original product commands premium pricing, generic options from Teva or Sun Pharma can increase access in emerging markets.
Strategic Implications for Stakeholders
- Healthcare Providers should prioritize sourcing from reputable suppliers with proven GMP compliance to ensure product safety and efficacy.
- Distributors must verify regulatory approvals and maintain cold chain logistics to preserve product integrity.
- Pharmaceutical Companies aiming to manufacture or import preservative-free etoposide must establish robust quality assurance frameworks, secure supply agreements, and navigate complex regulatory pathways.
Key Takeaways
- Pfizer remains the primary global supplier of Etopophos Preservative Free, with a longstanding market presence and regulatory approval.
- Generics manufacturers like Teva and Sandoz offer alternative preservative-free etoposide options, often at lower costs, expanding access.
- The limited number of qualified manufacturers underscores the importance of rigorous quality standards and supply chain resilience.
- Regional players such as Sun Pharma are critical for ensuring local availability, especially in Asia.
- Maintaining compliance with international regulatory standards is paramount to avoid disruptions in cancer therapeutics supply chains.
FAQs
1. Is Pfizer still the main supplier of Etopophos Preservative Free globally?
Yes, Pfizer remains the primary approved manufacturer and supplier, especially in established markets such as North America and Europe.
2. Are generic versions of preservative-free etoposide available?
Several generics, including those from Teva and Sandoz, offer preservative-free etoposide formulations, providing more cost-effective options in various regions.
3. What should healthcare providers consider when sourcing Etopophos Preservative Free?
Providers should verify product authenticity, regulatory approval, GMP compliance, and proper cold chain logistics to ensure drug potency and safety.
4. Are there supply risks associated with Etopophos Preservative Free?
Limited manufacturers and complex sterile production processes pose supply risks. Disruptions can arise due to manufacturing issues, regulatory changes, or raw material shortages.
5. How can emerging markets improve access to preservative-free etoposide?
Encouraging local manufacturing under license agreements, facilitating regulatory approvals, and promoting competition can enhance supply and reduce costs.
References
[1] Pfizer Inc. Official Product Information.
[2] Teva Pharmaceutical Industries Ltd. Product Catalog.
[3] Sandoz Official Website. Product Portfolio.
[4] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[5] Regulatory guidelines on sterile injectable manufacturing, FDA and EMA.
This analysis aims to empower business professionals and healthcare decision-makers with comprehensive insights into the supply landscape for Etopophos Preservative Free, enhancing procurement strategies and ensuring uninterrupted cancer treatment delivery.
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