Bulk Pharmaceutical API Sources for PERSANTINE

Bulk Pharmaceutical API Sources for PERSANTINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D9766_SIGMA
TCI (Tokyo Chemical Industry)		D2274
Molport		MolPort-001-792-504
Hangzhou APIChem Technology		AC-18100
AKos Consulting & Solutions		AKOS000509426

Bulk Active Pharmaceutical Ingredient (API) Sources for PERSANTINE

Last updated: July 28, 2025

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Introduction

Persantine, with the generic name dipyridamole, is a well-established pharmaceutical compound primarily employed for its antiplatelet and vasodilatory properties. It is commonly prescribed to prevent thromboembolic events post-myocardial infarction, stroke, and during coronary artery bypass grafting. As demand for Persantine persists globally, the sourcing of high-quality bulk Active Pharmaceutical Ingredient (API) remains critical for pharmaceutical manufacturers, generic drug producers, and research institutions. This article provides a comprehensive overview of current bulk API sources for Persantine, detailing manufacturing geographies, key suppliers, industry trends, and considerations for procurement professionals.

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1. Understanding Persantine (Dipyridamole) API

Dipyridamole is a synthetic phosphodiesterase inhibitor that increases cyclic AMP levels within platelets, thereby exerting its antiplatelet action. The API has been in medical use for decades, with a well-defined synthesis process, typically involving multi-step chemical reactions from readily available precursors.

The global production of dipyridamole API is characterized by a handful of seasoned manufacturers, mainly situated within established pharmaceutical hubs in Asia, Europe, and North America. The API's stability and established manufacturing protocols facilitate quality assurance, but sourcing remains complex, authenticating supplier credibility crucial to regulatory compliance.

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2. Global API Manufacturing Landscape for Persantine

2.1 Key Manufacturing Countries

• China: Leading producer of dipyridamole API, with a significant share attributed to numerous large-scale API manufacturers. Chinese suppliers often offer competitive pricing due to economies of scale and extensive manufacturing infrastructure. Companies such as Zhejiang Hisun Pharmaceutical and Guangzhou Hanfang Pharmaceutical are among prominent API manufacturers in China.

• India: India hosts several reputable API manufacturers that produce Persantine to GMP standards. Companies like Lupin Pharmaceuticals, Sun Pharmaceutical Industries, and Aurobindo Pharma are recognized globally for their quality API production, with strict adherence to regulatory standards, including US FDA and EMA approvals.

• European Union: European manufacturers, such as H. Lundbeck and Dr. Reddy’s Laboratories (India-based with European distribution), maintain high standards for API quality and regulatory compliance. While production costs are generally higher, the European sourcing option ensures supply chain stability and premium quality.

• United States: The U.S. maintains limited domestic API production for Persantine, primarily for specialized uses or research purposes. Most API imports into the U.S. originate from Asia and Europe.

2.2 Industry Trends in API Sourcing

• Shift Toward Contract Manufacturing: Contract manufacturing organizations (CMOs) managing dipyridamole API production have grown in prominence, offering scalability, quality consistency, and regulatory compliance. This trend facilitates supply chain flexibility and risk mitigation.

• Regulatory Considerations: Suppliers with established validation history, GMP compliance, and regulatory approvals in target markets (e.g., FDA, EMA) are preferred. Emergence of cGMP-certified Chinese and Indian API manufacturers enhances sourcing options.

• Supply Chain Diversification: Due to geopolitical tensions, the COVID-19 pandemic, and trade disruptions, pharmaceutical companies are diversifying API sources to ensure uninterrupted supply.

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3. Leading Suppliers of Persantine API

3.1 Major Chinese API Manufacturers

• Zhejiang Hisun Pharmaceutical Co., Ltd.: A large-scale manufacturer producing dipyridamole API under strict GMP standards, with distribution to global markets.

• Guangzhou Hanfang Pharmaceutical: Offers comprehensive API production, including dipyridamole, with certifications suitable for international markets.

• Shangpharma: An increasingly prominent API manufacturer with a focus on high-quality synthesis processes for dipyridamole.

3.2 Indian API Manufacturers

• Lupin Pharmaceuticals: Known for GMP-compliant dipyridamole API, with a strong presence in North America, Europe, and Asia.

• Sun Pharmaceutical Industries: Provides high-quality APIs and has a dedicated focus on cardiovascular APIs, including dipyridamole.

• Aurobindo Pharma: Active in API synthesis with multiple US FDA-approved manufacturing sites, offering reliable sourcing.

3.3 European Manufacturers

• H. Lundbeck: Primarily involved in pharmaceutical R&D but maintains select API manufacturing capabilities for key compounds, including dipyridamole.

• EuroAPI: European API producer focusing on high-quality standards for diverse pharmaceutical APIs, including dipyridamole, with good regulatory track record.

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4. Procurement Considerations for Persantine API

• Qualification and Validation: Ensuring the supplier’s manufacturing facilities comply with GMP standards, and the API batches are validated based on purity, potency, and stability is critical.

• Regulatory Approvals: Suppliers possessing certifications such as US FDA Drug Master Files (DMFs) or European EDQM certificates offer advantages in regulatory submission processes.

• Quality Control: Robust quality control measures, including comprehensive analytical testing (HPLC, GC, spectroscopic methods), ensure API consistency.

• Pricing and Lead Times: Competitive pricing must be balanced with quality assurance. Lead times depend on supplier manufacturing capacity, order volume, and logistics.

• Supply Chain Risk Management: Diversify sources across geographies to mitigate risks related to geopolitical tensions, trade restrictions, or logistical disruptions.

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5. Future Outlook

The demand for Persantine API is anticipated to remain stable, supported by its long-standing clinical application. However, emerging alternatives in antiplatelet therapy could influence future demand. Additionally, technological advancements in synthesis and quality management may alter supply dynamics, making newer suppliers with innovative manufacturing processes more prominent.

The trend toward increased outsourcing to CMOs and reliance on Asian manufacturers suggests a consolidated infrastructure that prioritizes cost-efficiency and compliance, yet emphasizes thorough due diligence from procurers.

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Key Takeaways

• Diverse Global Sources: Chinese and Indian manufacturers dominate the Persantine API market, with European suppliers positioned to meet high-quality standards.

• Regulatory Compliance Priority: Ensuring suppliers possess GMP certification and relevant regulatory approvals mitigates compliance risks.

• Supply Chain Diversification: Relying on multiple suppliers minimizes risks associated with geopolitical, logistic, or regulatory disruptions.

• Quality Assurance as a Cornerstone: Rigorous QC protocols underpin API reliability, directly affecting pharmaceutical product safety and efficacy.

• Market Trends Favor Contract Manufacturing: CMOs facilitate scalable and compliant production, offering strategic advantages to pharmaceutical firms.

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FAQs

1. What are the primary manufacturing countries for Persantine API?
China and India are the leading producers, with European manufacturers also supplying high-quality API for regulated markets like the EU.

2. How can procurement professionals verify API supplier quality?
By reviewing GMP certifications, regulatory approvals (e.g., FDA, EMA), batch testing reports, and supplier audit histories.

3. Are there alternatives to traditional suppliers for Persantine API?
Emerging contract manufacturing organizations are providing reliable alternatives, often with enhanced compliance and scalability.

4. What is the typical lead time for sourcing Persantine API?
Lead times vary from 8 to 16 weeks depending on supplier capacity, order volume, and logistical factors.

5. How is the market for Persantine API expected to evolve?
Stable demand with potential shifts towards more cost-effective Asian manufacturers and increased focus on supply chain resilience.

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References

1. [1] U.S. Food and Drug Administration. “Drug Master Files (DMFs).” FDA.gov.
2. [2] European Directorate for the Quality of Medicines & HealthCare. “Certification of APIs.” EDQM.eu.
3. [3] GlobalData. “API Market Reports: Persantine (Dipyridamole).” 2022.
4. [4] PharmaSources. “API Manufacturer Directory 2023.” PharmaSources.com.
5. [5] IQVIA. “Pharmaceutical API Manufacturing Trends.” IQVIA Insights, 2022.

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Note: The procurement landscape may change over time; it is advisable to verify current supplier credentials and market conditions before engaging.