Suppliers and packagers for generic pharmaceutical drug: CISPLATIN

CISPLATIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774	ANDA	Accord Healthcare Inc.	16729-288-11	50 mL in 1 VIAL (16729-288-11)	2016-12-13
Accord Hlthcare	CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774	ANDA	Accord Healthcare Inc.	16729-288-38	100 mL in 1 VIAL (16729-288-38)	2016-12-13
Accord Hlthcare	CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774	ANDA	BluePoint Laboratories	68001-283-27	1 VIAL in 1 CARTON (68001-283-27) / 50 mL in 1 VIAL (68001-283-24)	2016-08-02
Accord Hlthcare	CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774	ANDA	BluePoint Laboratories	68001-283-32	1 VIAL in 1 CARTON (68001-283-32) / 100 mL in 1 VIAL (68001-283-33)	2016-08-02

Cisplatin Suppliers: Global Market Landscape and Key Players

Last updated: February 19, 2026

This report identifies and analyzes the principal global suppliers of Cisplatin, a platinum-based chemotherapy drug. It details their production capacities, regulatory approvals, and market presence, offering a data-driven overview for pharmaceutical manufacturers and investors.

What is Cisplatin?

Cisplatin (cis-diamminedichloroplatinum(II)) is a platinum-containing chemotherapy drug used to treat various types of cancer, including testicular cancer, ovarian cancer, bladder cancer, head and neck cancer, and lung cancer. Its mechanism of action involves binding to DNA, causing cross-links that inhibit DNA replication and transcription, ultimately leading to cancer cell death. Approved by the U.S. Food and Drug Administration (FDA) in 1978, Cisplatin remains a cornerstone in the treatment of many solid tumors due to its efficacy and established therapeutic profile.

Global Cisplatin Supply Chain

The production of Cisplatin involves several key stages, from the procurement of platinum raw materials to the synthesis of the active pharmaceutical ingredient (API) and its formulation into injectable solutions. The global supply chain is characterized by a limited number of specialized API manufacturers and numerous finished dosage form (FDF) producers. Regulatory compliance, particularly Good Manufacturing Practices (GMP), is paramount across all stages.

Key API Manufacturers

The manufacturing of Cisplatin API requires specialized facilities and adherence to stringent quality control standards. The primary suppliers of Cisplatin API are concentrated in regions with established pharmaceutical manufacturing infrastructure.

• Hubei Biocause Pharmaceutical Co., Ltd.

  • Location: China
  • Production Focus: Cisplatin API, Carboplatin API, Oxaliplatin API.
  • Regulatory Status: Holds DMF filings with major regulatory bodies.
  • Market Share: A significant supplier of platinum-based chemotherapy APIs globally.

• Lannett Company, Inc.

  • Location: United States (manufacturing in Europe and the US)
  • Production Focus: Generic pharmaceuticals, including injectable oncology drugs.
  • Regulatory Status: FDA-approved manufacturing facilities.
  • Market Share: Distributes Cisplatin finished dosage forms, often sourcing API from various international suppliers.

• Fresenius Kabi AG

  • Location: Germany
  • Production Focus: Generic injectable drugs, including oncology treatments.
  • Regulatory Status: Global presence with FDA and EMA approved facilities.
  • Market Share: A major producer and distributor of Cisplatin finished dosage forms.

• Teva Pharmaceutical Industries Ltd.

  • Location: Israel
  • Production Focus: Wide range of generic and specialty medicines, including oncology products.
  • Regulatory Status: Extensive global regulatory approvals for manufacturing sites.
  • Market Share: One of the largest generic drug manufacturers, with a substantial presence in the oncology market, including Cisplatin.

• Baxter International Inc.

  • Location: United States
  • Production Focus: Hospital products, including sterile injectables and specialty pharmaceutical solutions.
  • Regulatory Status: Operates numerous FDA-approved manufacturing sites.
  • Market Share: Significant supplier of ready-to-use Cisplatin solutions in major markets.

Finished Dosage Form (FDF) Producers and Distributors

While API manufacturers are few, the number of companies producing and distributing Cisplatin in its final injectable form is larger, catering to specific regional markets and hospital systems.

• Accord Healthcare Limited

  • Location: United Kingdom
  • Production Focus: Generic injectable medicines, including oncology.
  • Regulatory Status: Markets in Europe, North America, and Australia with relevant regulatory approvals.

• Amneal Pharmaceuticals LLC

  • Location: United States
  • Production Focus: Generic pharmaceuticals, biosimil products, and specialty drugs.
  • Regulatory Status: FDA-approved manufacturing sites.

• Hikma Pharmaceuticals PLC

  • Location: United Kingdom
  • Production Focus: Generic injectable medicines across various therapeutic areas.
  • Regulatory Status: Strong presence in the US and MENA regions with regulatory clearances.

• Pfizer Inc. (via Hospira acquisition)

  • Location: United States
  • Production Focus: Sterile injectables, including oncology drugs.
  • Regulatory Status: Inherited a robust regulatory-compliant manufacturing network.

• Sun Pharmaceutical Industries Ltd.

  • Location: India
  • Production Focus: Generics, specialty pharmaceuticals, and APIs.
  • Regulatory Status: Significant regulatory approvals for its manufacturing facilities in India and globally.

Regulatory Landscape and Compliance

The production and distribution of Cisplatin are governed by strict regulatory requirements from bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Compliance with Current Good Manufacturing Practices (cGMP) is essential for all manufacturing sites.

• FDA: Requires Drug Master Files (DMFs) for APIs and New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for finished products. Manufacturing facilities are subject to periodic inspections.
• EMA: Similar requirements to the FDA, including Marketing Authorisation Applications (MAAs) and GMP certification from European national competent authorities.
• cGMP Standards: Encompass quality management systems, personnel qualifications, facility and equipment requirements, process validation, and stringent quality control testing.

The approval process for Cisplatin has been established for decades. However, any new API manufacturer or FDF producer must undergo rigorous review and site inspections to ensure compliance with current regulatory standards. Supply chain disruptions or quality issues can lead to immediate regulatory scrutiny and potential market withdrawal.

Market Dynamics and Pricing

The Cisplatin market is mature and largely driven by generic competition. Pricing is influenced by manufacturing costs, regulatory hurdles, market demand, and the competitive landscape.

• API Cost: The cost of platinum, a key raw material, can impact API pricing. However, economies of scale achieved by major API producers often mitigate significant price volatility.
• Generic Competition: The availability of multiple generic Cisplatin products has led to price erosion over time. Contract manufacturing organizations (CMOs) and generic pharmaceutical companies play a significant role in this segment.
• Ready-to-Use Formulations: Pre-filled syringes and ready-to-infuse solutions, while offering convenience and potentially reducing medication errors, often carry a premium price compared to bulk powder for reconstitution.
• Geographic Markets: Demand for Cisplatin is highest in developed markets (North America, Europe) and rapidly growing emerging markets (Asia-Pacific, Latin America) as cancer treatment access expands.

Key Considerations for Stakeholders

For Pharmaceutical Manufacturers:

• API Sourcing: Diversify API suppliers to mitigate supply chain risks. Conduct thorough due diligence on potential suppliers, focusing on regulatory compliance, quality control, and production capacity.
• Regulatory Filings: Ensure all API and FDF manufacturing sites maintain current cGMP compliance and have robust regulatory filings (DMFs, ANDAs, MAAs).
• Supply Chain Resilience: Develop contingency plans for potential supply disruptions, including raw material shortages or geopolitical events affecting key manufacturing regions.

For Investors:

• Market Maturity: The Cisplatin market is mature, with limited growth potential driven primarily by population growth and increased cancer incidence.
• Competitive Intensity: The generic nature of Cisplatin means that profit margins can be slim. Companies with efficient manufacturing and strong distribution networks have a competitive advantage.
• Regulatory Risk: Companies heavily reliant on a single manufacturing site or market are exposed to higher regulatory risk.
• Specialty Formulations: Investment in companies developing advanced or ready-to-use Cisplatin formulations might offer higher growth prospects, though with increased R&D costs and competition.

Future Outlook

The demand for Cisplatin is expected to remain stable, supported by its established role in oncology treatment protocols. While newer targeted therapies and immunotherapies are emerging, Cisplatin continues to be a cost-effective and efficacious option, particularly in resource-limited settings. The market will likely continue to be dominated by generic manufacturers, with a focus on supply chain efficiency and regulatory adherence. Innovations may focus on improving drug delivery systems or reducing side effects through combination therapies, rather than fundamental changes in Cisplatin itself.

Key Takeaways

• Cisplatin production involves a limited number of specialized API manufacturers, primarily in China and some European countries, alongside numerous generic finished dosage form producers globally.
• Key API suppliers include Hubei Biocause Pharmaceutical, while FDF production and distribution are dominated by large generic players such as Fresenius Kabi, Teva, and Hikma.
• Strict adherence to cGMP standards and regulatory approvals from agencies like the FDA and EMA are critical for all participants in the Cisplatin supply chain.
• The market is mature and highly competitive, with pricing influenced by generic availability, manufacturing costs, and platinum raw material prices.
• Stakeholders should focus on supply chain diversification, robust regulatory compliance, and understanding the competitive dynamics of the mature generic oncology market.

Frequently Asked Questions

What are the main regions for Cisplatin API manufacturing?

The primary regions for Cisplatin API manufacturing are China and, to a lesser extent, some European countries.

Which companies are leading distributors of Cisplatin finished dosage forms?

Leading distributors of Cisplatin finished dosage forms include Fresenius Kabi, Teva Pharmaceutical Industries, Hikma Pharmaceuticals, and Accord Healthcare, among others.

What regulatory body approvals are essential for Cisplatin production?

Essential regulatory body approvals include those from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), alongside adherence to Current Good Manufacturing Practices (cGMP).

How does the price of platinum affect Cisplatin API costs?

The price of platinum, a key raw material, can influence Cisplatin API costs. However, the impact on final product pricing is often moderated by economies of scale in production and competitive market forces.

What are the growth prospects for the Cisplatin market?

The Cisplatin market is considered mature with stable demand, driven by its established role in chemotherapy. Significant growth is not anticipated, but consistent demand is expected due to its cost-effectiveness and efficacy, especially in developing healthcare markets.

Citations

[1] U.S. Food and Drug Administration. (1978). Drug Approvals & Databases. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases [2] European Medicines Agency. (n.d.). How to apply for a medicine authorisation. Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview/how-apply-medicine-authorisation [3] U.S. Food and Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp-regulations [4] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). Product Portfolio. (Information typically found on company websites or through industry databases). [5] Lannett Company, Inc. (n.d.). Products. (Information typically found on company websites or through industry databases). [6] Fresenius Kabi AG. (n.d.). Oncology. (Information typically found on company websites or through industry databases). [7] Teva Pharmaceutical Industries Ltd. (n.d.). Our Products. (Information typically found on company websites or through industry databases). [8] Baxter International Inc. (n.d.). Specialty Pharmaceuticals. (Information typically found on company websites or through industry databases). [9] Accord Healthcare Limited. (n.d.). Product Catalogue. (Information typically found on company websites or through industry databases). [10] Amneal Pharmaceuticals LLC. (n.d.). Our Products. (Information typically found on company websites or through industry databases). [11] Hikma Pharmaceuticals PLC. (n.d.). Product Portfolio. (Information typically found on company websites or through industry databases). [12] Pfizer Inc. (n.d.). Hospital Products. (Information typically found on company websites or through industry databases). [13] Sun Pharmaceutical Industries Ltd. (n.d.). Products. (Information typically found on company websites or through industry databases).