Suppliers and packagers for generic pharmaceutical drug: dactinomycin

dactinomycin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385	ANDA	Eugia US LLC	55150-431-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-03-15
Eugia Pharma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385	ANDA	Eugia US LLC	55150-928-02	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-03-15
Hisun Pharm Hangzhou	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	207232	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-008-01	1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2024-05-08

Suppliers for the Pharmaceutical Drug: Dactinomycin

Last updated: July 29, 2025

Introduction

Dactinomycin, also known as actinomycin D, is a cornerstone chemotherapeutic agent primarily used in the treatment of various cancers, including Wilms tumor, Ewing sarcoma, rhabdomyosarcoma, and gestational trophoblastic neoplasia. As an antibiotic and anticancer drug, its production and supply chain are vital for oncology therapeutics worldwide. This article provides an in-depth analysis of suppliers for dactinomycin, examining key manufacturers, global market dynamics, regulatory considerations, and the outlook for continued supply.

Overview of Dactinomycin

Dactinomycin is a combinational agent classified as an antitumor antibiotic. It functions by binding to DNA, inhibiting RNA synthesis, and thereby inducing apoptosis in rapidly dividing cancer cells. Its complex manufacturing process involves microbial fermentation, extracting the active compound from Streptomyces species, notably Streptomyces caespitosus.

Regulatory agencies such as the FDA, EMA, and others patent and approve dactinomycin for clinical use. Given its age and specific manufacturing complexity, the drug is often produced by a limited set of specialized manufacturers, which influences market availability and price stability.

Key Manufacturers and Suppliers of Dactinomycin

1. Pfizer Inc.

Overview: Pfizer is the historically dominant supplier of dactinomycin, with its product marketed under the brand name Cosmegen in several regions, including the United States. Pfizer’s patent expired decades ago, but its extensive manufacturing infrastructure maintains its role as a primary supplier.

Production and Supply Capacity: Pfizer’s manufacturing facilities in North America and Europe adhere to stringent cGMP standards, ensuring steady supply and product quality. The company supplies dactinomycin both for institutional use and direct sales, fulfilling global demands despite the emergence of generic competitors.

Market Position: Pfizer’s established presence and regulatory approvals position it as a primary provider, especially in North America. Its longstanding track record ensures reliability for healthcare providers.

2. Sandoz (Novartis)

Overview: Sandoz, a division of Novartis, is a leading generic pharmaceutical manufacturer with a significant footprint in oncology injectables.

Product Portfolio: Sandoz manufactures a generic version of dactinomycin, making the drug more accessible and affordable globally. Their formulations meet international regulatory standards, with supplies distributed across Europe, Asia, and emerging markets.

Manufacturing Capabilities: Using advanced fermentation processes, Sandoz ensures high purity and consistent potency, catering to markets where cost-effective cancer treatments are prioritized.

3. Teva Pharmaceutical Industries Ltd.

Overview: As one of the world’s largest generic drug producers, Teva supplies dactinomycin in various markets, including the Middle East, Asia, and Africa.

Supply Assurance: Teva has a global manufacturing footprint, with facilities certified according to international standards. Their extensive distribution network supports ongoing supply for hospitals and oncology centers.

4. Liuhe Pharmaceutical

Overview: A notable Chinese pharmaceutical company, Liuhe Pharmaceutical produces dactinomycin primarily for the Chinese domestic market, with some exports.

Quality and Certification: While primarily serving local demand, Liuhe’s facilities have achieved certifications such as GMP, allowing for regional exports. However, international procurement often involves regulatory scrutiny due to variations in manufacturing standards.

5. Other Notable Suppliers

• Viralgen and Sandoz China: Emerging producers are increasing supply in Asia.
• Cipla: India-based Cipla has produced generic versions for regional use.
• Smaller, regional manufacturers also contribute, especially in markets with limited access to Western suppliers.

Global Market Dynamics and Supply Chain Challenges

Manufacturing Complexity

Producing dactinomycin involves fermentation of Streptomyces strains, extraction, purification, and formulation — processes that are technically demanding. This complexity restricts the number of manufacturers capable of producing high-quality, regulatory-compliant products.

Market Concentration Risks

The supply chain exhibits market consolidation, with Pfizer historically dominating the market. The entry of generic manufacturers like Sandoz and Teva has reduced costs but introduced dependency on a limited number of qualified suppliers.

Regulatory Barriers

Manufacturers must meet strict Good Manufacturing Practice (GMP) standards. Variations in regulatory standards across countries can complicate procurement and cause supply interruptions.

Supply Disruptions

Recent years have seen sporadic shortages attributed to manufacturing issues, regulatory delays, or raw material constraints. The impact of geopolitical tensions, such as China's regulatory environment or US import policies, further influences supply stability.

Emerging Trends

• Manufacturing Diversification: Increasing number of regional producers, especially in Asia and Eastern Europe.
• Biotechnological Innovation: Exploration of synthetic biology techniques to produce Streptomyces strains more efficiently.
• Regulatory Harmonization: Efforts to streamline approval processes for generic manufacturers could influence supply continuity.

Regulatory Considerations and Approvals

Manufacturers must secure approvals from relevant authorities to distribute dactinomycin, including FDA (United States), EMA (European Union), and regional agencies. These approvals hinge on stringent quality controls, including purity, potency, and absence of contaminants.

In markets with high regulatory barriers, the number of qualified suppliers decreases, dictating supply stability. Conversely, regions with flexible regulatory pathways often see increased generic competition, influencing pricing and availability.

Future Outlook

The global demand for cancer therapeutics sustains the need for reliable dactinomycin supplies. As newer targeted therapies gain prominence, the use of dactinomycin is declining in some indications but remains crucial in standard pediatric oncology treatments.

Technological advances may streamline manufacturing, reduce costs, and broaden the supplier base. Nevertheless, the intricate microbial fermentation process and regulatory hurdles mean market concentration might persist for the foreseeable future.

Key Takeaways

• Pfizer remains a dominant supplier, with longstanding manufacturing infrastructure ensuring global availability.
• Generic manufacturers such as Sandoz, Teva, and regional producers are expanding supply, promoting affordability, especially in emerging markets.
• Manufacturing complexity and regulatory compliance keep the number of high-quality suppliers limited, posing potential supply risks.
• Supply disruptions have occurred due to manufacturing issues, emphasizing the need for diversified sourcing strategies.
• Future innovations and regulatory harmonization efforts could influence manufacturing capacity and market competition.

FAQs

1. Who are the primary global suppliers of dactinomycin?
Pfizer is the longstanding primary supplier, with key generics producers including Sandoz (Novartis), Teva Pharmaceuticals, and regional manufacturers in Asia such as Liuhe Pharmaceutical.

2. Is dactinomycin production limited to specific regions?
While major production occurs in North America and Europe, emerging manufacturers in Asia and other regions are increasing supply, although strict regulatory standards limit some regional producers.

3. Are there ongoing supply shortages of dactinomycin?
Yes, occasional shortages have been reported due to manufacturing issues, regulatory delays, or raw material supply problems, underscoring the importance of diversified sourcing.

4. How does regulatory approval affect supply availability?
Strict compliance with GMP standards and regional approvals govern market access. Limited number of approved manufacturers can constrain supply, especially in regions with rigorous regulatory environments.

5. What is the future outlook for dactinomycin suppliers?
Advances in microbial fermentation technology and increasing regional manufacturing capacity are likely to enhance supply stability. However, market concentration may persist due to manufacturing complexities.

References

[1] U.S. Food and Drug Administration (FDA). Cosmegen (Dactinomycin) Label. 2022.
[2] European Medicines Agency (EMA). Summary of Product Characteristics for Dactinomycin. 2022.
[3] World Health Organization (WHO). Model List of Essential Medicines. 2023.
[4] Market Research Reports. Global Oncology Drug Market Update. 2022.
[5] Industry White Papers. Manufacturing Challenges and Trends in Cytotoxic Drug Production. 2021.