Suppliers and packagers for generic pharmaceutical drug: MITOMYCIN

MITOMYCIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaukos	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572	NDA	Mobius Therapeutics LLC	49771-002-03	3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS	2012-02-08
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144	ANDA	Accord Healthcare, Inc.	16729-108-11	1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) / 40 mL in 1 VIAL	2009-06-10
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144	ANDA	Accord Healthcare, Inc.	16729-115-05	1 VIAL in 1 CARTON (16729-115-05) / 10 mL in 1 VIAL	2009-06-18
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144	ANDA	Accord Healthcare, Inc.	16729-116-38	1 VIAL in 1 BOX, UNIT-DOSE (16729-116-38) / 80 mL in 1 VIAL	2011-03-11

Suppliers for the Pharmaceutical Drug: Mitomycin

Last updated: July 29, 2025

Introduction

Mitomycin, a potent antineoplastic agent, is employed primarily in chemotherapy for various carcinomas, including gastric, colorectal, and esophageal cancers. Known for its DNA cross-linking capabilities, mitomycin inhibits DNA synthesis, leading to cell death. Due to its critical role in cancer treatment, the procurement of high-quality mitomycin from reliable suppliers is vital for pharmaceutical companies, hospitals, and research institutions. This article provides a comprehensive overview of the major suppliers of mitomycin, analysis of their market positioning, and considerations for sourcing this pharmaceutical compound.

Understanding Mitomycin Production and Supply Chain

Mitomycin is derived from Streptomyces caespitosus, a soil bacterium first isolated in the 1950s. The manufacturing process involves fermentation followed by complex purification steps. The limited number of manufacturers capable of producing pharmaceutical-grade mitomycin results in a relatively concentrated supply chain, emphasizing the importance of established, compliant suppliers adhering to Good Manufacturing Practices (GMP).

Major Global Suppliers of Mitomycin

1. Pfizer Inc.

Overview:
Pfizer is a prominent global pharmaceutical giant with a long-standing presence in anticancer agents, including mitomycin. Historically, Pfizer has supplied mitomycin under brand names such as Mutamycin (approved in multiple countries), making it one of the most recognized sources.

Market Position:
Pfizer’s extensive distribution network, stringent quality controls, and regulatory compliance position it as a preferred supplier in both developed and emerging markets. Pfizer's production facilities meet international GMP standards, ensuring drug consistency, safety, and efficacy.

Supply Dynamics:
Pfizer maintains substantial inventory levels and engages in strategic partnerships with biosafety-approved fermentation facilities. The company offers both finished pharmaceutical formulations and bulk active pharmaceutical ingredients (APIs).

Regulatory Approvals and Availability:
Pfizer’s mitomycin products are approved by agencies such as the U.S. FDA, EMA, and other national regulatory authorities, facilitating broad accessibility.

2. Sandoz (Novartis Group)

Overview:
Sandoz, a division of Novartis, specializes in biosimilars and generic pharmaceuticals. It supplies mitomycin as part of its oncology product portfolio, primarily targeting markets where generic options are preferred for cost-efficiency.

Market Position:
Sandoz’s manufacturing adheres to strict GMP standards, with a focus on quality and affordability. The company’s global footprint ensures supply continuity, especially in low- and middle-income markets.

Supply Dynamics:
Sandoz supplies mitomycin in various formulations, including lyophilized powder for injection, with clear documentation of API purity and potency. They have established distribution channels in Europe, North America, and Asia.

3. Sinopharm Group & China National Pharmaceutical Group (CNPGC)

Overview:
Chinese state-owned pharmaceutical conglomerates such as Sinopharm and CNPGC have increased their presence in the production of anticancer APIs, including mitomycin. These firms benefit from advanced fermentation technology and large-scale manufacturing.

Market Position:
While primarily serving domestic markets, these suppliers are increasingly exporting to Asia-Pacific, Africa, and parts of Europe, often at competitive prices. Their compliance with international standards varies but is improving with ongoing compliance upgrades.

Supply Dynamics:
Chinese suppliers have scalable fermentation facilities and are investing heavily in quality control to meet international standards. They often provide screening samples for validation before bulk procurement.

4. Jiangsu Hengrui Medicine Co., Ltd.

Overview:
Hengrui is a leading Chinese pharmaceutical manufacturer with a broad oncology portfolio, including mitomycin. The company has made significant investments in GMP-compliant fermentation processes.

Market Position:
Hengrui’s focus on innovation, cost competitiveness, and expanding regulatory approvals makes it a key player tailored toward international markets such as the Asia-Pacific and some parts of Europe.

Supply Dynamics:
Hengrui’s mitomycin is often procured as bulk API, with increasing registration and acceptance in multiple countries due to their adherence to quality standards.

5. Other Notable Suppliers:

• ACON Laboratories: Known for generic anticancer drugs, including mitomycin, primarily serving North America.
• LGM Pharma & Spectrum Chemical: Distributors that source APIs from various manufacturers, including China and India, offering mitomycin for research and clinical use.
• Indian API Manufacturers: Several Indian companies produce mitomycin as part of their anticancer API portfolio, including companies like Shilpa Medicare and Aurobindo Pharma, catering largely to generics markets.

Emerging and Specialized Suppliers

• Tianjin East Delta Medicine Co., Ltd. — Focused on API manufacture for export, with GMP-certified facilities aimed at global markets.
• Hubei Hegang Pharmaceutical Co., Ltd. — Developing bio-fermentation processes to increase yield and purity.

Quality and Regulatory Considerations

Procurement of mitomycin requires strict adherence to GMP, as APIs and finished drugs face stringent regulatory scrutiny. Suppliers’ compliance with authorities such as the FDA, EMA, and PMDA significantly influences procurement decisions. Supply contracts often include batch-specific certificates of analysis, stability data, and validated manufacturing processes.

Market Trends and Future Outlook

The demand for mitomycin remains stable due to its proven efficacy in multiple chemotherapeutic regimens. Supplier diversification is increasingly prioritized to mitigate supply chain disruptions, especially considering geopolitical factors and manufacturing bottlenecks. Emerging producers in Asia are investing heavily in bio-fermentation and purification technology to meet international standards, opening new avenues for sourcing mitomycin more competitively.

Conclusion

The global supply of mitomycin predominantly revolves around manufacturing capacity from Pfizer, Sandoz, and Chinese state-owned enterprises such as Sinopharm and Hengrui. While Pfizer remains a benchmark for quality and reliability, Chinese manufacturers are expanding their footprint, offering cost-effective options. Due diligence regarding supplier compliance, quality assurance, and regulatory approvals remains paramount for secure procurement.

Key Takeaways

• Pfizer and Sandoz remain key global suppliers, trusted for quality and regulatory compliance.
• Chinese pharmaceutical companies like Sinopharm and Hengrui are growing as cost-competitive alternatives.
• Procurement must prioritize GMP compliance, batch certification, and regulatory approval.
• Diversifying suppliers reduces risk amid geopolitical and supply chain uncertainties.
• Continuous monitoring of market trends and emerging manufacturers enhances supply security.

---

FAQs

1. Is mitomycin available as a generic drug?
Yes. Several generic manufacturers, including Sandoz and Indian API producers, supply mitomycin as generics, often at lower costs than branded versions.

2. Which regulatory bodies approve mitomycin products?
Major approvals come from the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies supporting both finished formulations and bulk APIs.

3. How can I ensure quality when sourcing mitomycin internationally?
Verify GMP certification, review batch certificates of analysis, conduct supplier audits, and request regulatory audit reports to ensure compliance and product quality.

4. Are there bio-similar or alternative drugs to mitomycin?
While no direct biosimilar exists for mitomycin, alternative antineoplastic agents are available; however, mitomycin’s unique mechanism makes it a specific component of certain chemotherapy regimens.

5. What are the current supply challenges for mitomycin?
Manufacturing complexity, geopolitical factors, regulatory delays, and pandemic-related disruptions can impact supply continuity, underscoring the importance of diversified sourcing.

---

References

1. [1] Pfizer’s official website and product documentation.
2. [2] Novartis/Sandoz product portfolios and market reports.
3. [3] Chinese pharmaceutical industry publications and regulatory updates.
4. [4] Industry analysis reports on anticancer APIs and global supply chain dynamics.
5. [5] WHO guidelines on quality assurance for pharmaceuticals.