Suppliers and packagers for PLATINOL

PLATINOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057	NDA	WG Critical Care, LLC	44567-509-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-509-01) / 50 mL in 1 VIAL, MULTI-DOSE	2012-01-13
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057	NDA	WG Critical Care, LLC	44567-510-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-510-01) / 100 mL in 1 VIAL, MULTI-DOSE	2012-01-13
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057	NDA	WG Critical Care, LLC	44567-511-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-511-01) / 200 mL in 1 VIAL, MULTI-DOSE	2015-04-15
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057	NDA	WG Critical Care, LLC	44567-530-01	1 VIAL in 1 CARTON (44567-530-01) / 50 mL in 1 VIAL	2019-04-05

Suppliers for the Pharmaceutical Drug: PLATINOL

Last updated: August 5, 2025

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Introduction

PLATINOL, the brand name for cisplatin, is a potent chemotherapeutic agent primarily used in the treatment of various cancers, including testicular, ovarian, bladder, lung, and head and neck cancers. Since its discovery in the 1960s and subsequent FDA approval in 1978, cisplatin has become a cornerstone drug in oncology treatment regimens. As with many critical pharmaceuticals, supply security hinges on a diversified network of reliable suppliers. This article explores the current landscape of PLATINOL manufacturers, emphasizing their market roles, manufacturing capabilities, and future outlooks.

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Global Manufacturing Landscape of PLATINOL (Cisplatin)

Major Pharmaceutical Companies Producing Cisplatin

1. *Teva Pharmaceuticals /

   • Overview: A leading global generic pharmaceutical manufacturer headquartered in Israel, Teva has been a principal supplier of cisplatin for decades.
   • Manufacturing Capabilities: Teva operates several manufacturing facilities worldwide, including production lines dedicated to cytotoxic agents such as cisplatin, ensuring high-volume supply and consistent quality.
   • Market Position: Teva's extensive distribution network makes it a key supplier in both mature and emerging markets, serving hospitals and oncology clinics globally.

2. Hospira (A Pfizer Business)

   • Overview: Hospira, acquired by Pfizer in 2015, specializes in sterile injectables, including chemotherapeutic agents.
   • Manufacturing Capabilities: Facilities in the U.S. and Europe enable Hospira to produce cisplatin under strict regulatory standards, bolstering supply reliability.
   • Market Role: Their role predominantly focuses on North American and European markets, securing a significant share of chemotherapy-grade cisplatin.

3. Sanofi-Aventis

   • Overview: Sanofi manufactures cytotoxic compounds, including cisplatin, through its specialty pharmaceuticals division.
   • Manufacturing Capabilities: With global manufacturing sites, Sanofi guarantees high-purity cisplatin production aligned with global regulatory standards.
   • Distribution Focus: Emphasis on European and Asian markets, with strategic supply agreements ensuring availability.

4. Swiss-based Fix-designs and other regional suppliers

   • Several regional manufacturers and compounding pharmacies manufacture generic cisplatin formulations, often for local markets or specialized use.
   • These suppliers typically operate under strict quality controls, often sourcing cisplatin from larger manufacturers or producing under licensing agreements.

Imported and Contract Manufacturing Options

In addition to these primary manufacturers, several pharmaceutical companies rely on contract manufacturing organizations (CMOs) for cisplatin production, which offers flexibility and capacity expansion. Notably:

• Contract production agreements are common among smaller or regional firms, allowing them to meet regional demand without major capital investment.
• Supply chain diversification is critical as geopolitical factors, regulatory scrutiny, or manufacturing disruptions can impact availability.

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Regulatory and Supply Considerations

• Regulatory Approvals: Suppliers must adhere to stringent standards outlined by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and WHO Prequalification programs.
• Material Sourcing: Cisplatin is synthesized using platinum compounds, often utilizing platinum sourced from major mining regions like South Africa, Russia, and Australia. Fluctuations in platinum market prices or geopolitical issues can affect supply stability.
• Quality & Certification: Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), ensuring batch consistency and safety.
• Potential Shortages: Supply disruptions have occurred historically due to manufacturing issues, raw material shortages, or regulatory delays, underscoring the importance of diversified sourcing strategies.

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Emerging Trends and Future Outlook

• Generic Market Expansion: The increasing prevalence of cancer treatments has driven demand; as a result, generic manufacturers are expanding their production capacity.
• Biotech Alternatives: Research into platinum-based compounds and targeted therapies may influence the demand for cisplatin; however, it remains a mainstay due to its proven efficacy.
• Supply Chain Resilience: Companies are investing in upstream raw material sourcing, manufacturing capacity improvements, and strategic inventories to mitigate risks.
• Regulatory Harmonization: Efforts to standardize manufacturing and approval processes globally aim to streamline supply chains and reduce bottlenecks.

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Competitive and Strategic Implications for Stakeholders

• Healthcare Providers and Distributors: Must maintain relationships with multiple approved suppliers to ensure no disruption in chemotherapy availability.
• Pharmaceutical Manufacturers: Should evaluate supply chain vulnerabilities, especially regarding raw material procurement and manufacturing capacity expansion.
• Investors and Industry Analysts: Opportunities exist in supporting or partnering with emerging suppliers focusing on cost-effective, high-quality cisplatin manufacturing.

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Conclusion

The supply chain for PLATINOL (cisplatin) remains predominantly anchored by global pharmaceutical giants such as Teva, Pfizer's Hospira division, and Sanofi. While these companies provide the bulk of approved, high-quality formulations, regional and generic manufacturers serve as critical secondary sources, particularly in emerging markets. Ensuring supply resilience involves continuous monitoring of manufacturing capacities, raw material availability, and regulatory landscapes. As the demand for effective cancer therapies persists, supply chain diversification and capacity expansion will be vital to sustain the global availability of PLATINOL.

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Key Takeaways

• Major manufacturers such as Teva, Pfizer's Hospira, and Sanofi dominate the cisplatin supply landscape.
• Regional and generic producers play significant roles, especially in local markets, though they depend on global supply chains for raw materials.
• Raw material sourcing, particularly platinum supply, is a critical factor influencing the stability of cisplatin production.
• Regulatory compliance and quality assurance are essential for suppliers to maintain market approval and avoid shortages.
• Supply chain resilience can be strengthened through diversification, strategic inventory management, and investments in manufacturing capacity.

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FAQs

1. Who are the primary global suppliers of PLATINOL (cisplatin)?
   The leading suppliers include Teva Pharmaceuticals, Hospira (a Pfizer company), and Sanofi, each with extensive manufacturing and distribution networks.

2. What factors could impact the production and supply of cisplatin?
   Factors include raw material availability (platinum), manufacturing capacity limitations, regulatory delays, geopolitical issues, and raw material price fluctuations.

3. Are there regional differences in cisplatin sourcing?
   Yes. While global companies dominate the market, regional and generic manufacturers serve local needs, often sourcing from international suppliers to meet regional demand.

4. What role do regulatory standards play in cisplatin supply?
   Strict adherence to GMP and regulatory approvals are crucial for manufacturing and exporting cisplatin, ensuring product safety, efficacy, and market authorization.

5. Is there potential for supply shortages in the future?
   Yes. Historical instances of supply interruptions indicate a need for diversified sourcing and capacity planning to mitigate future shortages.

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Sources

[1] "Cisplatin," U.S. Food and Drug Administration.
[2] "Global Sales of Chemotherapy Drugs," IQVIA Institute.
[3] "Pharmaceuticals and Raw Material Sourcing," World Platinum Investment Council.
[4] "Medical Manufacturing Regulatory Standards," EMA.
[5] "Market Analysis of Oncology Drugs," GlobalData Pharmaceuticals.