Suppliers and packagers for generic pharmaceutical drug: PENTOXIFYLLINE

PENTOXIFYLLINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	074878	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8511-39	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8511-39)	2024-01-15
Ani Pharms	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	074878	ANDA	ANI Pharmaceuticals, Inc.	70954-668-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70954-668-10)	2024-01-15
Ani Pharms	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	074878	ANDA	ANI Pharmaceuticals, Inc.	70954-668-20	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70954-668-20)	2024-01-15

Suppliers for the Pharmaceutical Drug: Pentoxifylline

Last updated: July 29, 2025

Introduction

Pentoxifylline, a methylxanthine derivative, is primarily prescribed for the treatment of peripheral vascular disease, particularly describing its ability to improve blood flow. It functions as a hemorrheologic agent, reducing blood viscosity and enhancing microcirculatory flow. As demand for this medication persists across global markets, especially in cardiovascular and cerebrovascular applications, understanding key suppliers becomes vital for pharmaceutical companies, healthcare providers, and investors seeking secure sourcing channels.

This comprehensive review details the leading manufacturers and suppliers of pentoxifylline, exploring the global production landscape, regulatory considerations, and future procurement trends.

Manufacturers and Suppliers Overview

1. Originator and Major Generic Manufacturers

a) Sanofi (Daflon and Pentoxifylline Production)
Sanofi, a multinational pharmaceutical leader headquartered in France, was among the pioneering firms involved in the development and distribution of pentoxifylline. Although primarily renowned for other medications, Sanofi has historically supplied pentoxifylline formulations, notably in Europe and selected Asian markets. Their production facilities adhere to stringent Good Manufacturing Practices (GMP), ensuring high-quality standards compliant with regulatory authorities such as EMA and FDA.

b) Boehringer Ingelheim
This German pharmaceutical giant manufactures and supplies pentoxifylline through licensing agreements and their own product lines, especially in Europe. Their expertise in small molecule production and global distribution channels position them as a significant supplier.

c) Teva Pharmaceutical Industries Ltd.
As one of the world's largest generic drug companies headquartered in Israel, Teva supplies pentoxifylline across numerous markets. Their extensive manufacturing network and robust supply chain infrastructure enable consistent product availability at competitive prices. Teva’s production includes various formulations, such as oral tablets and extended-release versions, catering to diverse clinical needs.

2. Asian Manufacturers and Regional Suppliers

a) Lupin Limited (India)
Lupin is a leading Indian pharmaceutical manufacturer with a diversified portfolio, including pentoxifylline. Their production facilities comply with multiple regulatory standards, enabling exports to the US, Europe, and emerging markets.

b) Cipla Limited (India)
Cipla’s reputation for affordable pharmaceuticals includes pentoxifylline, marketed mainly within India and other developing markets. Their focus on cost-effective manufacturing positions them as key suppliers for budget-conscious healthcare settings.

c) Hetero Labs Ltd.
Another Indian originator, Hetero provides generic formulations, including pentoxifylline, with expanding exports to Africa, Southeast Asia, and Latin America.

3. Chinese and Southeast Asian Generic Manufacturers

China and Southeast Asia have become significant hubs for small molecule pharmaceuticals, including pentoxifylline. Manufacturers such as Zhejiang Hisun Pharmaceutical and Jiangsu Hengrui Medicine produce bulk active pharmaceutical ingredients (APIs) and finished dosage forms for local and export markets. The growing quality standards in China have enabled these firms to export APIs to Western generic manufacturers, further extending their influence in the global supply chain.

4. Active Pharmaceutical Ingredient (API) Suppliers

a) Dalimmed (South Korea)
Specializing in critical APIs, Dalimmed supplies high-grade pentoxifylline APIs to regional and international pharmaceutical firms.

b) Aurobindo Pharma (India)
Aurobindo provides both APIs and finished formulations, with a growing presence in the US, Europe, and Asia.

c) Suzhou Aareal Pharmaceutical
Focused on API manufacturing in China, this company supplies high-purity pentoxifylline APIs aligned with international standards.

Key Regional Markets and Supplier Dynamics

United States and Europe

In North America and Europe, pentoxifylline is primarily supplied by established global players like Teva and Boehringer Ingelheim. Regulatory compliance and consistent quality are critical factors for market access, with approvals from agencies such as the FDA and EMA serving as market entry prerequisites.

Emerging Markets

India, China, and Latin American countries host numerous domestic manufacturers that supply lower-cost alternatives. Companies such as Lupin, Cipla, and Hetero dominate these regions with manufacturing facilities that meet local regulatory standards, offering flexibility and short lead times.

Regulatory Considerations

Manufacturers must register their products with local agencies, including the FDA (U.S.), EMA (Europe), CDSCO (India), and similar authorities. The API’s quality, stability data, and bioequivalence studies influence approval and marketability, rendering supplier reliability essential.

Supply Chain and Sourcing Considerations

Quality and Regulatory Compliance

Secure sourcing depends significantly on adherence to GMP and regulatory approvals. Suppliers with established track records and certifications mitigate risks related to substandard products and legal compliance.

Formulation and Supply Chain Flexibility

Many suppliers provide multiple formulations, including immediate and extended-release tablets, to meet diverse clinical needs.

Price Competitiveness

Generic manufacturers mainly compete on cost, affecting procurement strategies, especially in resource-constrained healthcare systems. Maintaining diversified supplier portfolios can mitigate supply disruptions and price fluctuations.

Global Supply Disruptions

Factors such as geopolitical tensions, manufacturing bottlenecks, and COVID-19 impacts have underscored the importance of multiple sourcing channels to ensure uninterrupted supply.

Future Trends and Procurement Outlook

The global pentoxifylline market is poised for stability owing to its longstanding therapeutic role. However, competition among suppliers is intensifying, driven by:

• Increased interest in biosimilars and novel formulations that may replace traditional pentoxifylline therapies.
• Evolving regulations prompting manufacturers to upgrade their GMP standards.
• Expansion into emerging markets with growing cardiovascular disease burdens.

Pharmaceutical buyers should prioritize establishing relationships with multiple verified suppliers, focusing on API quality certifications, regulatory status, and reliable delivery timelines.

Key Takeaways

• Leading global suppliers include Sanofi, Boehringer Ingelheim, and Teva, with local manufacturing dominance in India and China by companies such as Lupin, Cipla, and Zhejiang Hisun.
• Regional variations in supplier choices are driven by regulatory standards, cost considerations, and market access, emphasizing the importance of diversified sourcing.
• Regulatory compliance remains critical—suppliers with FDA, EMA, and other international certifications ensure smoother market access.
• Supply chain resilience can be fortified through multi-supplier arrangements and proactive quality assessments.
• Future procurement should prioritize agile sourcing strategies aligned with regulatory developments and evolving market demands.

---

FAQs

1. Who are the top global suppliers of pentoxifylline?
The leading international manufacturers include Teva Pharmaceutical Industries, Boehringer Ingelheim, and Sanofi, supported by regional producers such as Lupin and Cipla in India.

2. How do regional market demands influence supplier selection?
Market-specific regulatory requirements, pricing, and existing domestic manufacturing capacities shape procurement strategies, with emerging economies often relying on local and regional manufacturers for cost-effective options.

3. What regulatory considerations should buyers prioritize?
Ensuring suppliers possess GMP certification and approvals from authorities like the FDA or EMA reduces compliance risks and guarantees product quality.

4. Are there risks associated with sourcing pentoxifylline from emerging markets?
Yes, risks include variability in product quality, regulatory stability, and supply chain disruptions. Due diligence and supplier qualification are imperative.

5. How is the market expected to evolve in the coming years?
The pentoxifylline market will likely experience steady demand, with increased focus on quality standards, regulatory compliance, and diversified supply chains to mitigate disruptions.

---

References

1. [1] "Pentoxifylline: Uses, Dosage, Side Effects," WebMD, 2023.
2. [2] "Global Pharmaceutical API Market Analysis," MarketWatch, 2023.
3. [3] "Indian Pharmaceutical Industry," Department of Pharmaceuticals, Government of India, 2022.
4. [4] "EMA Approved Medicines," European Medicines Agency, 2023.
5. [5] "Top Generic Drug Manufacturers," IQVIA Institute, 2022.