Suppliers and packagers for generic pharmaceutical drug: CYTARABINE

CYTARABINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	CYTARABINE	cytarabine	INJECTABLE;INJECTION	076512	ANDA	Fresenius Kabi USA, LLC	63323-120-20	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE	2004-11-29
Gland	CYTARABINE	cytarabine	INJECTABLE;INJECTION	211938	ANDA	Sagent Pharmaceuticals	25021-223-20	1 VIAL in 1 CARTON (25021-223-20) / 20 mL in 1 VIAL	2023-06-01
Gland	CYTARABINE	cytarabine	INJECTABLE;INJECTION	211938	ANDA	Gland Pharma Limited	68083-337-01	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-337-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2019-12-23
Gland	CYTARABINE	cytarabine	INJECTABLE;INJECTION	211937	ANDA	Sagent Pharmaceuticals	25021-229-05	5 VIAL in 1 CARTON (25021-229-05) / 5 mL in 1 VIAL	2023-06-01

Pharmaceutical Drug Suppliers: Cytarabine

Last updated: February 19, 2026

This report details the key global suppliers of Cytarabine, a critical chemotherapeutic agent. The analysis focuses on manufacturing capabilities, regulatory standing, and market presence to inform strategic R&D and investment decisions.

Who Are the Primary Manufacturers of Cytarabine Active Pharmaceutical Ingredient (API)?

Multiple entities manufacture Cytarabine API, operating across different regulatory jurisdictions. The primary suppliers include:

• Euticals plc: A United Kingdom-based contract development and manufacturing organization (CDMO). Euticals has a long-standing presence in API manufacturing. The company operates facilities compliant with current Good Manufacturing Practices (cGMP) across Europe.
• Hovione Farmaciência S.A.: Headquartered in Portugal, Hovione is a global CDMO with significant expertise in complex API synthesis. They possess multiple cGMP-certified facilities in Europe and the United States. Hovione's product portfolio includes a range of oncology APIs.
• Hikma Pharmaceuticals PLC: A multinational pharmaceutical company with headquarters in the United Kingdom. Hikma manufactures and distributes a broad spectrum of generic pharmaceuticals, including injectable drugs. Their API manufacturing operations are subject to regulatory oversight from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Fresenius Kabi AG: This German healthcare company is a leading provider of infusion and transfusion technology and pharmaceuticals. Fresenius Kabi manufactures finished dosage forms and also engages in API production for several oncology drugs. Their facilities adhere to international quality standards.
• Teva Pharmaceutical Industries Ltd.: An Israeli multinational pharmaceutical company, Teva is one of the world's largest generic drug manufacturers. They produce a wide array of APIs, including those for chemotherapy agents. Teva's manufacturing sites are regularly inspected by global regulatory bodies.

These companies represent a significant portion of the global supply chain for Cytarabine API. Their production capacities, quality control systems, and regulatory approvals are critical factors for pharmaceutical companies seeking reliable sourcing.

What Are the Regulatory Statuses of Key Cytarabine Manufacturers?

The regulatory compliance of Cytarabine API suppliers is paramount for ensuring drug safety and efficacy. Key manufacturers hold certifications and have undergone inspections by major health authorities.

• FDA Inspections: Facilities operated by Hovione, Hikma, Teva, and Fresenius Kabi have undergone and passed FDA inspections, indicating compliance with U.S. cGMP requirements. Euticals also maintains a history of FDA compliance for its relevant manufacturing sites.
• EMA Approvals: Manufacturers supplying to the European market must adhere to EMA guidelines. Hovione, Euticals, Fresenius Kabi, and Teva have manufacturing sites approved by European regulatory authorities. Hikma's operations also meet EMA standards for its product lines.
• Other Jurisdictional Approvals: Beyond the U.S. and Europe, leading suppliers often hold approvals from other national regulatory agencies, such as Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO). This broad regulatory acceptance facilitates global market access.
• Drug Master Files (DMFs): Many Cytarabine API manufacturers maintain U.S. DMFs or European Active Substance Master Files (ASMFs). These confidential documents provide detailed information about the manufacturing process, facilities, and quality control of the API. They are reviewed by regulatory agencies during the approval process for finished drug products.

A review of recent inspection reports and active DMFs provides evidence of ongoing regulatory adherence. For instance, public records from the FDA’s inspection database and European Medicines Agency (EMA)’s EudraGMDP database can be cross-referenced to verify the compliance status of specific manufacturing sites.

What is the Market Landscape for Cytarabine API and Finished Dosage Forms?

The Cytarabine market is characterized by a mix of established players and a growing demand driven by its role in treating hematological malignancies.

Key Market Segments:

• API Manufacturing: Dominated by a limited number of specialized CDMOs and large generic manufacturers with integrated API capabilities. Pricing is influenced by production volume, purity specifications, and regulatory compliance costs.
• Finished Dosage Forms (FDFs): This segment includes injectable solutions and suspensions. Key players here are often generics manufacturers who source API and formulate the final product. The market is competitive, with a focus on stable supply chains and cost-effectiveness.

Major Global Suppliers of Finished Cytarabine Products:

• Hikma Pharmaceuticals PLC: Offers a range of Cytarabine injectable products in vials, widely distributed in North America and Europe.
• Fresenius Kabi AG: A significant provider of injectable oncology drugs, including Cytarabine, for hospital use.
• Teva Pharmaceutical Industries Ltd.: Markets Cytarabine generics in various strengths and presentations.
• Accord Healthcare (a subsidiary of Intas Pharmaceuticals): Has a presence in multiple global markets with generic Cytarabine formulations.
• Hospira (now part of Pfizer): Historically a major supplier of oncology injectables, including Cytarabine, though market presence may evolve.

Market Trends:

• Increased Incidence of Hematological Cancers: Growing global rates of leukemia and lymphoma directly impact demand for Cytarabine.
• Generic Competition: The market for Cytarabine is largely driven by generic products, emphasizing price sensitivity and supply reliability.
• Supply Chain Resilience: Pharmaceutical companies are increasingly focused on diversifying their supplier base to mitigate risks associated with geopolitical events or manufacturing disruptions.
• Regulatory Scrutiny: Ongoing and stringent regulatory oversight of API and FDF manufacturing maintains a high barrier to entry for new suppliers.

The total global market for Cytarabine, encompassing both API and finished products, is estimated to be in the hundreds of millions of dollars annually. Precise market share figures fluctuate based on regional demand and competitive dynamics.

What Are the Production Capacities and Technical Specifications for Cytarabine API?

Production of Cytarabine API involves complex multi-step synthesis. Manufacturers must adhere to strict specifications to ensure API quality.

Typical Technical Specifications for Cytarabine API:

• Assay: NLT 98.0% and NMT 102.0% (on an anhydrous, solvent-free basis). This indicates the purity of the Cytarabine compound.
• Appearance: White to off-white crystalline powder.
• Water Content: NMT 1.0% (by Karl Fischer titration). Water content can affect stability and is a critical control parameter.
• Related Substances: Specific limits are set for known impurities, including degradation products and process-related byproducts. These are typically measured by High-Performance Liquid Chromatography (HPLC). For example, common impurities might have limits of NMT 0.1% to 0.5% depending on their classification.
• Heavy Metals: NMT 10 ppm.
• Residual Solvents: Limits adhere to ICH Q3C guidelines, specifying acceptable levels for solvents used during synthesis and purification. Common solvents include ethanol, methanol, and isopropyl alcohol, with specific ppm limits.
• Microbial Limits: Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) are controlled, along with the absence of specific objectionable microorganisms.

Manufacturing Process Considerations:

• Synthetic Route: The chemical synthesis of Cytarabine (Cytosine arabinoside) typically involves glycosylation of a protected cytosine derivative with a protected arabinose derivative, followed by deprotection steps.
• Chiral Purity: Cytarabine is a chiral molecule. The manufacturing process must ensure the correct stereoisomer (arabinose configuration) is produced with high enantiomeric purity.
• Crystallization and Polymorphism: Control over crystallization is critical for achieving the desired particle size distribution, morphology, and polymorphic form, which can impact dissolution rates and bioavailability in the final drug product.

Production Capacity:

Specific production capacities are proprietary information for individual manufacturers. However, leading CDMOs and API manufacturers such as Hovione and Teva have demonstrated the ability to produce Cytarabine API at multi-ton scales annually to meet global demand. Their facilities are designed for high-volume synthesis while maintaining stringent quality control. The scale of production is often aligned with the market demand for Cytarabine generics and its use in standard chemotherapy regimens.

How Does the Supply Chain for Cytarabine Compare Across Different Regions?

The global supply chain for Cytarabine is complex, with API manufacturing concentrated in specific regions and finished product formulation occurring globally.

North America:

• API Sourcing: Primarily reliant on imports from Europe and Asia.
• FDF Manufacturing: Significant domestic manufacturing capacity for finished injectable dosage forms by companies like Hikma, Fresenius Kabi, and Teva, who operate U.S.-based production facilities. Strong regulatory oversight by the FDA.
• Distribution: A well-established distribution network serves hospitals and cancer treatment centers.

Europe:

• API Manufacturing: A key hub for API production, with companies like Euticals and Hovione based in the region. Strong adherence to EMA regulations.
• FDF Manufacturing: Several European pharmaceutical companies produce finished Cytarabine products for both domestic and export markets.
• Regulatory Environment: Harmonized regulatory standards through the EMA facilitate intra-European trade.

Asia (primarily India and China):

• API Manufacturing: Significant capacity for Cytarabine API production, often at competitive cost structures. Manufacturers in these regions increasingly meet international cGMP standards and export globally.
• FDF Manufacturing: Growing capabilities in FDF manufacturing, serving both domestic and international markets.
• Regulatory Landscape: While major manufacturers achieve FDA and EMA compliance, adherence to diverse national regulations requires careful management.

Key Supply Chain Considerations:

• Raw Material Sourcing: The availability and quality of key starting materials for Cytarabine synthesis are critical. These are often sourced globally, adding another layer of supply chain complexity.
• Logistics and Cold Chain: Cytarabine, particularly in its finished dosage form, may require specific temperature controls during transportation and storage to maintain stability. This necessitates robust cold chain logistics.
• Geopolitical and Economic Factors: Trade policies, currency fluctuations, and regional political stability can impact the cost and availability of both API and finished products.
• Regulatory Harmonization: Differences in regulatory requirements between countries can create challenges for manufacturers seeking to market their products globally.

The trend towards supply chain diversification is evident, with pharmaceutical companies actively seeking to reduce reliance on single sources or single geographic regions. This involves qualifying multiple API suppliers and establishing robust inventory management strategies.

Key Takeaways

• Supplier Landscape: Key global Cytarabine API suppliers include Euticals, Hovione, Hikma Pharmaceuticals, Fresenius Kabi, and Teva Pharmaceutical Industries.
• Regulatory Compliance: Major manufacturers hold critical FDA and EMA approvals, essential for market access and product integrity. Drug Master Files are standard.
• Market Dynamics: The Cytarabine market is driven by generic competition and increasing demand for hematological cancer treatments. Supply chain resilience is a significant industry focus.
• Technical Standards: Cytarabine API must meet stringent purity, impurity, and residual solvent specifications, typically verified by HPLC and other analytical methods.
• Regional Supply Chains: API manufacturing is concentrated in Europe and Asia, with significant FDF production in North America and Europe. Diversification of supply chains is a strategic imperative.

Frequently Asked Questions

1. What is the primary therapeutic use of Cytarabine? Cytarabine is primarily used as a chemotherapeutic agent for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and other hematological malignancies.

2. What are the main challenges in manufacturing Cytarabine API? Challenges include ensuring high chemical purity, controlling related substances and impurities, achieving the correct stereochemical configuration, and managing residual solvents, all within a cGMP-compliant framework.

3. How does the regulatory pathway for Cytarabine API differ between the U.S. and Europe? In the U.S., API manufacturers often file Drug Master Files (DMFs) with the FDA. In Europe, equivalent documentation is typically submitted as an Active Substance Master File (ASMF) to national competent authorities or the EMA. Both require rigorous quality data and manufacturing site inspections.

4. What are the implications of the patent landscape for Cytarabine? Cytarabine is a well-established drug; its original patents have long expired. The market is dominated by generic products. Patent activity is now primarily focused on novel formulations, delivery systems, or combination therapies involving Cytarabine.

5. Can I use multiple suppliers for Cytarabine API for the same finished drug product? Yes, pharmaceutical companies routinely qualify and use multiple suppliers for critical APIs like Cytarabine. This strategy enhances supply chain security, mitigates risks of shortages, and can provide leverage in price negotiations, provided all suppliers meet the required regulatory and quality standards.

Citations

[1] Euticals plc. (n.d.). Product Portfolio. Retrieved from [Manufacturer Website - specific URL if available/publicly accessible, otherwise general company site] [2] Hovione Farmaciência S.A. (n.d.). Oncology APIs. Retrieved from [Manufacturer Website - specific URL if available/publicly accessible, otherwise general company site] [3] Hikma Pharmaceuticals PLC. (n.d.). Generics Portfolio. Retrieved from [Manufacturer Website - specific URL if available/publicly accessible, otherwise general company site] [4] Fresenius Kabi AG. (n.d.). Oncology Products. Retrieved from [Manufacturer Website - specific URL if available/publicly accessible, otherwise general company site] [5] Teva Pharmaceutical Industries Ltd. (n.d.). API Manufacturing. Retrieved from [Manufacturer Website - specific URL if available/publicly accessible, otherwise general company site] [6] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA Website - e.g., FDA.gov] [7] European Medicines Agency. (n.d.). EudraGMDP Database. Retrieved from [EMA Website - e.g., EMA.Europa.eu] [8] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Q3C(R5) Impurities: Guideline for Residual Solvents. [9] Various pharmaceutical market research reports on the global oncology drug market and Cytarabine market (specific report details would be provided if publicly accessible and utilized, e.g., Grand View Research, MarketsandMarkets).