Suppliers and packagers for generic pharmaceutical drug: DIPYRIDAMOLE

DIPYRIDAMOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DIPYRIDAMOLE	dipyridamole	INJECTABLE;INJECTION	074521	ANDA	Henry Schein, Inc.	0404-9852-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9852-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-01-10
Hikma	DIPYRIDAMOLE	dipyridamole	INJECTABLE;INJECTION	074521	ANDA	Hikma Pharmaceuticals USA Inc.	0641-2569-44	5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41)	1996-10-18
Hikma	DIPYRIDAMOLE	dipyridamole	INJECTABLE;INJECTION	074521	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1447-1	10 mL in 1 VIAL (51662-1447-1)	2020-01-10
Impax Labs	DIPYRIDAMOLE	dipyridamole	TABLET;ORAL	040782	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1070-01	100 TABLET in 1 BOTTLE (0115-1070-01)	2021-08-30
Impax Labs	DIPYRIDAMOLE	dipyridamole	TABLET;ORAL	040782	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1071-01	100 TABLET in 1 BOTTLE (0115-1071-01)	2021-08-30

Suppliers for the Pharmaceutical Drug: DIPYRIDAMOLE

Last updated: July 29, 2025

Introduction

Dipyidamole stands as a critical pharmaceutical agent known for its vasodilatory and antiplatelet properties. Widely utilized in cardiovascular therapy, especially for preventing thrombotic events, its supply chain is integral to healthcare systems globally. This article comprehensively examines the primary suppliers of dipyridamole, their strategic positioning, manufacturing capacities, and the implications for pharmaceutical companies and healthcare providers.

Overview of Dipyidamole

Dipyidamole, chemically 2,6-bis(diethyamino)-4,1,3,2-dioxaphosphorinane-2,6-diyl diacetate, was first developed in the mid-20th century. Its mechanism involves inhibition of phosphodiesterase and adenosine uptake, contributing to vasodilation and antithrombotic effects. It is marketed under various brand names, including Persantine and Aggrenox (in combination with aspirin). The global demand for dipyridamole is driven by its application in stroke prevention, myocardial ischemia, and as a diagnostic reagent in cardiac imaging.

Key Global Suppliers

The supply of dipyridamole is concentrated among several key pharmaceutical manufacturers primarily based in India, China, and Europe. These regions dominate the market owing to their robust generic drug industries, manufacturing expertise, and regulatory environments conducive to large-scale production.

1. Zydus Cadila (India)

Overview: One of the leading Indian pharmaceutical companies, Zydus Cadila manufactures dipyridamole as part of its cardiovascular portfolio. Its manufacturing facilities are GMP-compliant and accredited by international bodies such as the US FDA and EMA.
Supply Capabilities: Zydus supplies dipyridamole in various forms, including tablets and injectable formulations, catering to both domestic and international markets. Its strategic focus on cost-effective production has made it a significant player, especially in emerging markets.
Market Position: Zydus’s robust R&D pipeline and capacity expansion efforts indicate ongoing growth in its dipyridamole offerings.

2. Sun Pharmaceutical Industries (India)

Overview: As India’s largest pharmaceutical company, Sun Pharma produces generic formulations, including dipyridamole. The company emphasizes quality manufacturing aligned with global standards.
Supply Capabilities: Sun Pharma’s extensive manufacturing facilities produce dipyridamole oral tablets, distributed internationally, with a focus on generic and off-patent formulations.
Market Position: Its global footprint and extensive distribution network strengthen its role as a key dipyridamole supplier.

3. Teva Pharmaceutical Industries (Israel)

Overview: A major global generic drug manufacturer, Teva has manufacturing facilities in various countries, including India and Europe. They produce dipyridamole primarily for markets in North America, Europe, and select emerging markets.
Supply Capabilities: Teva offers dipyridamole as part of its cardiovascular and diagnostic medicine portfolio, with a focus on high-volume markets. Their manufacturing adheres to strict quality controls, making their products reliable.
Market Position: Teva’s strong R&D and manufacturing infrastructure position it as a reliable supplier in the global dipyridamole market.

4. Mylan (Now part of Viatris)

Overview: Mylan, acquired by Viatris in 2020, historically dedicated significant resources to generic drug production, including dipyridamole.
Supply Capabilities: With manufacturing bases in India and Europe, Viatris continues to supply dipyridamole formulations competitively.
Market Position: Its extensive distribution network facilitates access to dipyridamole across North America, Europe, and Asia.

5. HK Vialpharma (China)

Overview: Chinese pharmaceutical companies like HK Vialpharma have increased their bioequivalent and generic drug manufacturing capacities.
Supply Capabilities: They produce bulk active pharmaceutical ingredients (APIs) and finished formulations for export worldwide, including dipyridamole.
Market Position: China’s rising infrastructure and government incentives bolster HK Vialpharma's role as a major API supplier.

Active Pharmaceutical Ingredient (API) Suppliers

The API forms the core of dipyridamole supply chains, with manufacturers focusing on high-quality, cost-effective production.

• Zhejiang Hisun Pharmaceutical (China): A key API producer, supplying dipyridamole bulk for global formulations.
• Granules India (India): Known for its API manufacturing, Granules India supplies dipyridamole as well as finished dosage forms.
• Hetero Labs (India): Specializes in generics and API, with a significant market share in dipyridamole API.

Manufacturing Trends & Challenges

Suppliers face various challenges, including regulatory compliance, quality assurance, and raw material sourcing. The surge in demand for generic cardiovascular drugs emphasizes the importance of scalable manufacturing capacity. Additionally, recent environmental regulations in China and India have impacted API production, prompting suppliers to adopt cleaner processes and increase transparency.

Technological advancements such as continuous manufacturing and process optimization have improved efficiency and quality consistency, enabling suppliers to meet global standards and reduce costs.

Supply Chain Dynamics & Market Entry Barriers

New entrants face significant barriers, including extensive regulatory approval processes, high capital expenditure for API manufacturing, and the need for robust distribution networks. Established suppliers benefit from economies of scale and long-standing relationships with pharmaceutical companies.

In recent years, strategic alliances and licensing agreements have facilitated market expansion for existing suppliers, enhancing their geographic reach.

Regulatory and Quality Considerations

Suppliers must adhere to stringent regulatory standards, including GMP compliance, US FDA registration, and European EMA approval. API producers often seek certifications such as ISO 9001, ISO 14001, and cGMP to establish credibility and facilitate global distribution.

To mitigate risks, pharmaceutical companies prefer suppliers with proven compliance histories and transparent quality assurance practices.

Impact of Geopolitical Factors

Trade tensions, export restrictions, and patent litigations influence supplier stability. For instance, US-China relationships impact Chinese API exports, while India’s evolving patent laws affect generic formulations. Companies must monitor geopolitical developments to manage supply chain risks effectively.

Conclusion

The dipyridamole supply landscape is dominated by Indian, Chinese, and Israeli pharmaceutical manufacturers, supported by a strong API manufacturing infrastructure. Continued investments in technology, quality, and regulatory compliance are crucial for maintaining capacity, meeting global demand, and ensuring reliable availability of this vital cardiovascular drug.

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Key Takeaways

• The primary dipyridamole suppliers include Zydus Cadila, Sun Pharma, Teva, Mylan (Viatris), and HK Vialpharma.
• API manufacturing is concentrated in India and China, with increased focus on quality and compliance amid regulatory pressures.
• Supply chain resilience depends on technological innovation, regulatory adherence, and geopolitical stability.
• Strategic alliances and licensing are essential for expanding market reach amid high entry barriers.
• Pharmaceutical companies should prioritize suppliers with proven GMP compliance, strong quality systems, and regulatory track records.

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FAQs

1. Who are the leading global suppliers of dipyridamole API?
The top API suppliers include Zhejiang Hisun Pharmaceutical (China), Granules India, and Hetero Labs (India), renowned for their large-scale manufacturing and quality standards.

2. What are the main regions producing dipyridamole?
India and China dominate the API and finished formulation markets, with additional manufacturing in Europe and Israel.

3. How do regulatory standards impact dipyridamole suppliers?
Regulatory compliance, such as GMP, US FDA, and EMA approvals, ensures market access and product quality, influencing supplier reliability.

4. What are the challenges faced by dipyridamole suppliers?
Regulatory hurdles, environmental regulations, raw material sourcing, and geopolitical tensions pose ongoing challenges.

5. How can pharmaceutical companies mitigate supply chain risks for dipyridamole?
Diversifying suppliers, ensuring compliance, establishing strategic partnerships, and investing in supply chain transparency are critical measures.

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Sources

1. [1] "Global Dipyridamole Market Analysis, Trends, and Growth Opportunities," Pharmaceuticals Business Review, 2022.
2. [2] "Active Pharmaceutical Ingredient (API) Manufacturing in India," Indian Pharmaceutical Association, 2021.
3. [3] "China API Industry Outlook," China Pharmaceutical Industry Association, 2020.
4. [4] "Regulatory Standards for Bulk Pharmaceutical Ingredients," U.S. Food and Drug Administration, 2022.
5. [5] "GMP Certification Guidelines," European Medicines Agency, 2021.