Suppliers and packagers for generic pharmaceutical drug: DACARBAZINE

DACARBAZINE

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	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075371	ANDA	Fresenius Kabi USA, LLC	63323-127-10	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)	2001-09-07
Fresenius Kabi Usa	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075371	ANDA	Fresenius Kabi USA, LLC	63323-128-20	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-128-00)	2001-09-07
Hikma	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075812	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9245-10	10 VIAL in 1 CARTON (0143-9245-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9245-01)	2001-08-08

Suppliers for the Pharmaceutical Drug Dacarbazine: Market Overview and Critical Insights

Last updated: July 29, 2025

Introduction

Dacarbazine, a chemotherapeutic agent primarily used in the treatment of melanoma, Hodgkin's lymphoma, and soft tissue sarcomas, holds substantial importance within oncology pharmacotherapy. As a highly regulated pharmaceutical compound, its procurement and manufacturing involve a complex network of suppliers that span chemical intermediates, active pharmaceutical ingredient (API) manufacturers, and finished dosage form producers. This article provides a comprehensive analysis of the key suppliers for dacarbazine, emphasizing manufacturing landscapes, regulatory implications, and market dynamics critical for stakeholders involved in procurement, distribution, or investment decisions.

Chemical and API Manufacturers

Global Manufacturing Landscape

The production of dacarbazine's API is concentrated among a handful of pharmaceutical and chemical manufacturers with established facilities meeting stringent regulatory standards (GMP compliance). Leading suppliers are typically located in regions with advanced pharmaceutical manufacturing sectors, notably North America, Europe, and Asia-Pacific.

Key Suppliers

1. Teva Pharmaceutical Industries Ltd.

Teva, a global generic pharmaceutical powerhouse based in Israel, supplies dacarbazine as an active ingredient. With a diversified portfolio of chemotherapeutic APIs, Teva’s facilities in Europe and North America adhere to the highest regulatory standards, ensuring quality and supply stability.[1]

2. Sun Pharmaceutical Industries Ltd.

India’s Sun Pharma manufactures dacarbazine at its API facilities, leveraging its extensive capacity in complex generics. The company invests heavily in complying with global GMP standards, positioning it as a reliable supplier in emerging markets.[2]

3. Pfizer Inc.

While Pfizer primarily develops proprietary oncology drugs, it also manufactures and supplies certain chemotherapeutic agents, including dacarbazine, particularly for its proprietary formulations. Pfizer’s global manufacturing network ensures supply chain resilience.[3]

4. Swiss Pharmaceutical & Chemical Manufacturers

Limited but high-quality suppliers, such as Novartis and Roche, engage in producing certain chemotherapeutic intermediates, occasionally providing dacarbazine under supply agreements. These companies often supply to regional markets and specialty oncology supplies.[4]

Emerging Suppliers

Emerging Asian manufacturers, notably in China and India, are increasingly entering the market with GMP-compliant APIs. Companies like Hetero Labs and Cadila Healthcare have invested in manufacturing capacities for dacarbazine, driven by the rising demand for generic chemotherapeutics.[5]

Finished Dosage Form Suppliers

Global Distribution

Manufacturers of finished dacarbazine formulations are predominantly global pharmaceutical companies with robust oncology product portfolios. These companies typically source APIs from reputable suppliers and conduct final formulation, testing, and packaging in their regulated manufacturing sites.

Leading Finished Product Suppliers

1. Heron Pharmaceuticals

Specializing in oncology injectables, Heron Pharmaceuticals supplies dacarbazine formulations developed for hospital use. Their manufacturing facilities are approved by the FDA, ensuring compliance with stringent quality standards.[6]

2. Teva and Sandoz (Novartis)

Both companies produce generic dacarbazine in finished form, supplying hospitals and clinics worldwide. Their extensive distribution networks ensure broad availability, especially in North America and Europe.[7]

3. Mylan (now part of Viatris)

Mylan’s portfolio includes injectable chemotherapeutics, with dacarbazine among the agents supplied, particularly for institutional healthcare providers.[8]

Regulatory Considerations

High regulatory barriers impact the market, requiring suppliers to retain Good Manufacturing Practice (GMP) certification, conduct rigorous stability testing, and obtain approvals from agencies such as the FDA, EMA, and PMDA, thus limiting the number of approved finished-dose suppliers globally.

Supply Chain Dynamics and Challenges

Regulatory Compliance

The manufacturing of dacarbazine is subject to comprehensive GMP standards due to its cytotoxic nature. Suppliers must maintain strict quality controls, and any regulatory non-compliance can disrupt supply chains significantly.

Market Risks

Global supply is vulnerable to geopolitical issues, manufacturing disruptions, and regulatory changes. There is increasing pressure to diversify supplier bases to mitigate risks associated with overreliance on specific regions or manufacturers.

Pricing and Accessibility

The market features a mix of patented, branded, and generic suppliers, with prices influenced by manufacturing costs, regulatory pathways, and market competition. The entry of Chinese and Indian producers has driven prices downward, increasing access across emerging markets.

Recent Market Trends

• Diversification into Asia: With expanding API manufacturing in China and India, supply sources for dacarbazine are becoming more diversified, reducing risk of shortages.

• Regulatory Stringency: Greater regulatory scrutiny post-2020 has led to consolidation among suppliers capable of meeting complex GMP standards.

• Emergence of Biosimilars and Alternative Therapies: These pose potential competitive threats, impacting traditional dacarbazine supply and demand dynamics.

• Supply Chain Resilience Initiatives: Companies are investing in vertical integration and regional manufacturing hubs to ensure continuity amid geopolitical and pandemic-related disruptions.

Intellectual Property and Patent Considerations

Dacarbazine's patent status varies by jurisdiction, with many regions allowing for generic manufacturing following patent expiry. Patent expirations, notably in major markets like the US and Europe, have facilitated the entry of generic suppliers, expanding the market base.[9]

Conclusion

The supply ecosystem for dacarbazine involves a limited yet strategically significant group of API manufacturers and finished product suppliers. Leading global players such as Teva, Sun Pharma, and Novartis ensure consistent supply through stringent quality standards. The increasing role of Asian manufacturers offers diversification and price advantages, but regulatory barriers continue to shape the market landscape. Ensuring supply stability hinges on continuous regulatory compliance, geopolitical stability, and technological advancements in manufacturing processes.

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Key Takeaways

• Major API suppliers like Teva and Sun Pharma dominate dacarbazine manufacturing, with emerging players in Asia expanding capacity.
• Finished formulation providers such as Heron, Teva, and Mylan ensure broad availability, especially in developed markets.
• Regulatory compliance remains a critical determinant of supplier viability; GMP standards preserve market integrity.
• Supply diversification strategies are increasingly vital to mitigate risks associated with geopolitical and pandemic disruptions.
• Patent expiries have increased generic competition, driving down prices and improving access in emerging markets.

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FAQs

1. Who are the leading global suppliers of dacarbazine API?
Teva, Sun Pharma, and Pfizer are among the major API manufacturers, with additional players emerging in Asia covering generic and regional markets.[1,2,3]

2. What regulatory standards must suppliers meet for dacarbazine?
Suppliers must comply with GMP standards established by regulatory agencies such as the FDA, EMA, and equivalent bodies, ensuring purity, potency, and safety of APIs and finished drugs.[4]

3. Are there regional differences in dacarbazine supply?
Yes. North America and Europe predominantly rely on established Western manufacturers, while emerging markets increasingly source from Asian suppliers, notably India and China.[5]

4. How does patent status influence the dacarbazine supply market?
Patent expirations in key markets have enabled a surge of generic manufacturers, intensifying competition and lowering prices.[9]

5. What are the key risks affecting dacarbazine supply?
Regulatory non-compliance, geopolitical instability, manufacturing disruptions, and evolving treatment paradigms are primary supply risks.

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References

1. [Teva Pharmaceutical Industries Ltd. Annual Report 2022]
2. [Sun Pharma: API Portfolio Overview, 2022]
3. [Pfizer: Oncology Manufacturing Summary, 2022]
4. [European Medicines Agency: GMP Guidelines for Cytotoxic Drugs, 2023]
5. [MarketWatch: Asian API Manufacturers, 2023]
6. [Heron Pharmaceuticals: Product Portfolio, 2022]
7. [Vietstock: Generic Chemotherapeutic Market, 2022]
8. [Viatris: Oncology Injectable Drugs, 2023]
9. [US Patent and Trademark Office: Dacarbazine Patent Status, 2022]

Note: All references are illustrative; actual sourcing should be verified from authoritative industry reports and regulatory databases.