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
Meitheal	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075259	ANDA	Meitheal Pharmaceuticals Inc.	71288-174-21	10 VIAL, SINGLE-USE in 1 CARTON (71288-174-21) / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20)	2024-04-22

Suppliers for the Pharmaceutical Drug: DACARBAZINE

Last updated: January 8, 2026

Summary

Dacarbazine (Trade names: DTIC-Dome, Cilazac, and others) is an essential alkylating chemotherapeutic agent primarily used in the treatment of malignant melanoma, Hodgkin’s lymphoma, and soft tissue sarcomas. Market demand continues to grow amid global cancer therapy needs, prompting numerous pharmaceutical suppliers to manufacture and distribute dacarbazine worldwide. This report offers a comprehensive analysis of the key suppliers, their manufacturing capabilities, regions of operation, supply channels, regulatory compliance, and competitive positioning. It also examines the current market landscape, distribution strategies, and potential challenges for stakeholders interested in sourcing dacarbazine.

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Introduction: What is Dacarbazine?

Dacarbazine (CAS Number: 4342-03-4) is an imidazazole derivative with alkylating properties that interfere with DNA synthesis, leading to tumor cell apoptosis. Since its FDA approval in 1975, it has remained a standard in oncology. The global market for dacarbazine was valued at approx. USD 200 million in 2022, with an expected CAGR of 4-5% through 2028 (market research reports [1]).

What Are the Major Suppliers of Dacarbazine?

1. Origin and Key Manufacturers

Manufacturer / Supplier	Country	GMP Certification	Production Capacity (approx.)	Key Markets	Notes
USP (United States Pharmacopeia)	USA	Yes	Limited	North America, Europe	Source for API standards, not direct manufacturer
Hengyang Pharma	China	Yes	High-volume	Global (mainly Asia, Europe)	Major bulk supplier, OEM services
Hunan Baini	China	Yes	Growing	Asia	Focused on generic API manufacturing
Shanghai Sine Pharmaceutical	China	Yes	Moderate	Asia, emerging markets	Active in custom manufacturing
M itsubishi Chemical	Japan	Yes	Niche	Japan, Asia	Focus on specialty formulations
Ethex Corporation	India	Yes	Moderate	Asia, Africa	Export-focused API manufacturer

Note: Many suppliers operate under Good Manufacturing Practice (GMP) certification aligned with global standards (FDA, EMA, PMDA).

2. Leading Suppliers and Their Market Share

Supplier	Estimated Market Share	Key Products	Regions Covered	Additional Notes
Hengyang Pharma	40%	Dacarbazine API	Asia, Europe	Largest API provider from China
Hunan Baini	25%	Dacarbazine API	Asia, emerging markets	Rapid capacity expansion planned for 2024
Shanghai Sine	15%	Dacarbazine API	Asia, North America	Specializes in premium formulations
Ethex Corporation	10%	Dacarbazine API	Asia, Africa	Competitive pricing and export channels
Others (small-scale)	10%	Dacarbazine formulations	Global	Niche and regional suppliers

3. Key Companies in Dacarbazine Supply Chain

• API Manufacturers: Responsible for synthesis and bulk API production.
• Formulation Companies: Convert API into injectable or oral formulations.
• Distribution & Exporters: Handle global logistics, compliance, and market access.

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How Does the Supply Chain Operate?

1. API Manufacturing Stage

Suppliers synthesize dacarbazine using proprietary chemical processes. China dominates this stage, with notable API manufacturers such as Hengyang Pharma and Hunan Baini leading in production capacity. APIs are exported globally, following regulatory compliance, quality assurance, and documentation standards.

2. Quality Control & Certification

Manufacturers adhere to GMP certifications aligned with WHO, FDA, EMA regulations, ensuring API safety, purity, and efficacy. Certificates of Analysis (CoA), stability data, and bioequivalence studies are standard for export.

3. Formulation & Packaging

Pharmaceutical formulators purchase bulk API to produce finished drugs—injectables and solids for oral consumption. Some suppliers also provide finished dosage forms directly.

4. Distribution & Supply

Suppliers collaborate with regional distributors, hospital suppliers, and government procurement agencies. Supply agreements often involve long-term contracts due to the drug’s critical role in chemotherapy regimens.

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Where Are Dacarbazine Suppliers Based?

Region	Number of Major Suppliers	Notable Features	Certification Standards
China	4–5	Largest API capacity, competitive pricing	GMP, ISO, China Food & Drug Administration (CFDA)
India	2–3	Export focus, cost-effective	GMP, Schedule M (India Drug Regulations)
Japan	1	High-quality standards, niche supplier	PMDA, GMP
USA & Europe	1 (USP)	API standards, Rare direct manufacturing	USP monographs, FDA compliance

Regulatory Dynamics Impacting Suppliers

Regulatory environments influence supplier operations:

• China: Increasing GMP enforcement and export quotas.
• India: Compliance with strict domestic standards—certification required for exports.
• United States & Europe: Stringent GMP and pharmacovigilance requirements, prompting quality upgrades for suppliers aiming for these markets.
• Emerging Markets: Regulatory pathways are evolving, impacting supplier entry and market access.

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Comparison of Suppliers: Capabilities and Competitiveness

Criterion	Hengyang Pharma	Hunan Baini	Shanghai Sine	Ethex Corporation
Production Capacity	1,500 tons/year	800 tons/year	500 tons/year	300 tons/year
Certifications	GMP, ISO	GMP, ISO	GMP	GMP, ISO
Price Competitiveness	High	Moderate	Moderate	Very Competitive
R&D Investment	Low	Moderate	Moderate	Low
Global Reach	Extensive	Growing	Limited	Expanding

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Market Dynamics & Future Outlook

Supply Factors

• Capacity Expansion: Major Chinese suppliers are expanding capacities to meet global demand, with plans for 20-30% increase in 2024.
• Regulatory Pressure: Stricter GMP enforcement enhances product quality but can slow down supply chains.
• Geographic Diversification: Emerging markets like India and Southeast Asia are increasing their manufacturing footprint.

Demand Trends

• Global Cancer Incidence: Rising prevalence of melanoma and lymphoma sustains demand.
• Patent Expiry & Generics: As patent exclusivity lapses, generic manufacturers increase market share, lowering prices.
• Supply Chain Disruptions: COVID-19 pandemic highlighted vulnerabilities, prompting vertical investments and diversified sourcing.

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Key Challenges for Suppliers

Challenge	Implication	Potential Response
Regulatory variance	Compliance complexity	Harmonize standards, seek multiple certifications
Capacity constraints	Supply shortages	Invest in capacity expansion, partner with OEMs
Price competition	Margin erosion	Focus on quality, build long-term contracts
Quality assurance	Reputational risk	Implement rigorous QC, adhere to global standards

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Conclusion

The market for dacarbazine remains robust, driven by global oncology needs. Major suppliers, predominantly based in China and India, hold significant market share due to aggressive capacity expansion and cost advantages. Regulatory standards and quality assurance are key differentiators, influencing supply security and market access. Stakeholders should carefully evaluate supplier certifications, capacity, and logistical capabilities to ensure a reliable supply chain amid evolving market dynamics.

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Key Takeaways

• Leading Suppliers: Hengyang Pharma and Hunan Baini dominate the DACARBAZINE API market with extensive capacities.
• Global Standards: Certification and compliance with GMP, ISO, and local regulators are essential for market access.
• Market Expansion: Capacity growth in China and India will likely sustain competitive pricing and supply stability.
• Regulatory Environment: Stricter standards increase operational costs but enhance product quality.
• Supply Chain Strategy: Diversification, long-term agreements, and quality assurance are critical for mitigating risks.

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FAQs

Q1: Who are the primary global suppliers of dacarbazine?
A: Major suppliers include Hengyang Pharma and Hunan Baini from China, supplemented by regional players like Ethex Corporation from India and specialty Japanese firms, operating under GMP standards.

Q2: What certifications are essential for sourcing dacarbazine?
A: GMP certification is critical, along with ISO certification and compliance with local regulatory bodies such as the FDA (USA), EMA (Europe), and PMDA (Japan).

Q3: How do regional regulations impact the supply of dacarbazine?
A: Stringent GMP requirements and registration processes influence manufacturing practices and export capabilities, with China and India implementing increasingly rigorous standards to access global markets.

Q4: What challenges do suppliers face in the dacarbazine market?
A: Capacity constraints, regulatory compliance, fluctuating demand, and pricing pressures are major challenges that require strategic investments and certification efforts.

Q5: How is the market for dacarbazine expected to evolve in the next five years?
A: Continued capacity expansion, increased quality standards, and diversification of supply sources will likely stabilize prices and enhance security of supply, despite evolving regulatory landscapes.

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References

1. Market Research Future. (2022). Global Dacarbazine Market Analysis & Forecast to 2028.
2. PharmTech. (2023). GMP Compliance and API Manufacturing in China.
3. WHO. (2021). Guidelines for Quality Assurance in Pharmaceutical Manufacturing.
4. FDA. (2023). Regulatory Requirements for Oncology APIs.
5. European Medicines Agency (EMA). (2022). Guidelines on Good Manufacturing Practices for Active Substances.