Suppliers and packagers for generic pharmaceutical drug: FELODIPINE

FELODIPINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	203417	ANDA	A-S Medication Solutions	50090-5870-0	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5870-0)	2013-01-17
Aurobindo Pharma Ltd	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	203417	ANDA	Rising Pharma Holdings, Inc.	57237-108-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-108-01)	2013-01-17
Aurobindo Pharma Ltd	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	203417	ANDA	Rising Pharma Holdings, Inc.	57237-109-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-109-01)	2013-01-17

Suppliers for the Pharmaceutical Drug: FELODIPINE

Last updated: July 27, 2025

Introduction

Felodipine, a calcium channel blocker classified under dihydropyridines, is primarily prescribed for managing hypertension and angina pectoris. Since its FDA approval and adoption in cardiovascular therapy, the demand for Felodipine has grown markedly. This increase has fueled a complex global supply chain involving numerous manufacturers, suppliers, and distributors. Understanding the landscape of Felodipine suppliers is vital for stakeholders including pharmaceutical companies, healthcare providers, and policymakers aiming to ensure drug availability, cost-effectiveness, and supply chain resilience.

Global Suppliers and Manufacturers of Felodipine

1. Major Pharmaceutical Companies Producing Felodipine

Several prominent pharmaceutical firms hold manufacturing rights or produce generic versions of Felodipine:

• Mitsubishi Tanabe Pharma Corporation: As the original developer, Mitsubishi Tanabe possesses patent rights for Felodipine in several jurisdictions. Their manufacturing facilities supply the drug on a global scale, primarily in Japan and select markets adhering to their distribution licenses.

• Teva Pharmaceutical Industries Ltd.: A leading global generic pharmaceutical manufacturer, Teva produces Felodipine in multiple formulations, including tablets. Their extensive manufacturing network ensures broad distribution, especially in the Americas and Europe.

• Dr. Reddy’s Laboratories: This Indian pharmaceutical giant manufactures generic versions of Felodipine, catering to emerging markets and supplying several developed markets through strategic partnerships.

• Sun Pharmaceutical Industries Ltd.: Also based in India, Sun Pharma has expanded its portfolio to include Felodipine, serving markets in Asia, Africa, and Latin America.

• Aurobindo Pharma: Known for undercutting market prices with high-quality generics, Aurobindo supplies Felodipine to multiple regions, including the United States and Europe.

2. Contract Manufacturing Organizations (CMOs)

In addition to these large firms, numerous CMOs provide formulation and active pharmaceutical ingredient (API) manufacturing services:

• Jubilant Life Sciences: Provides API and formulation manufacturing, contributing to the global supply chain of Felodipine.

• Hetero Drugs: Offers API production and formulation services, focusing on cost-effective solutions for developing markets.

• Biocair and Thermo Fisher Scientific: While primarily logistics and supply chain firms, they facilitate the movement of Felodipine APIs and formulations across borders.

3. Key API Suppliers

The active pharmaceutical ingredient cemented the foundation of any Felodipine supply chain. Top API suppliers include:

• China-based API manufacturers: They dominate the API market for Felodipine owing to their extensive manufacturing capacity, cost advantage, and industrial scale.

• India-based API producers: Companies such as Aarti Drugs, Hetero Drugs, and Divis Laboratories produce high-grade APIs meeting international standards.

• European API manufacturers: Smaller but highly regulated producers ensure API quality and supply for markets with stringent regulatory requirements.

4. Regional Distributors and Wholesalers

In addition to primary manufacturers, regional and local distributors play instrumental roles in delivering Felodipine to pharmacies, hospitals, and clinics:

• McKesson and Cardinal Health (US): Distribute Felodipine formulations to retail outlets and hospitals across North America.

• Phoenix Pharma (Europe): Supplies European markets with generic antihypertensive drugs, including Felodipine.

• DAIICHI SANKYO and Nippon Kayaku: Regional distributors involved in Japanese and Asian markets.

Supply Chain Dynamics and Challenges

Pricing and Patent Status

In many regions, patent protection for Felodipine has lapsed, encouraging generics production. However, patent disputes, regulatory exclusivities, and market entry barriers persist. India, China, Europe, and the US exhibit diverse patent landscapes impacting supplier access.

Regulatory Compliance and Quality Standards

Manufacturers must adhere to Good Manufacturing Practices (GMP) and regulatory standards from agencies like the FDA, EMA, and PMDA. Variability in compliance levels affects supply reliability.

Raw Material Availability

APIs for Felodipine are primarily sourced from China and India, making supply vulnerable to geopolitical tensions, trade restrictions, and quality control issues.

Manufacturing Capacity Constraints

Pandemic-induced disruptions and capacity limitations have temporarily constrained supply, emphasizing the need for diversified supplier bases and strategic stockpiles.

Emerging Trends and Future Outlook

• Diversification of Supply Sources: To mitigate risks, stakeholders increasingly seek to diversify API and formulation suppliers globally, including investing in local manufacturing facilities.

• Regulatory Harmonization: Efforts by international agencies aim to streamline approval processes and ensure consistent quality in generic drugs, including Felodipine.

• Technological Innovation: Advancements in manufacturing, such as continuous flow processing, may increase efficiency and supply resilience.

• Environmental Considerations: Sustainability in manufacturing processes is gaining priority, influencing supplier selection.

Conclusion

The landscape of Felodipine suppliers is characterized by a mix of multinational pharmaceutical corporations, India-based generics producers, Chinese API suppliers, and regional distributors. The fragmentation of supply chains necessitates diligent oversight, diversification strategies, and adherence to regulatory standards to ensure consistent drug availability. Given the increasing global demand, stakeholders must monitor geopolitical developments, technological advancements, and regulatory changes to sustain a reliable supply of this vital antihypertensive agent.

Key Takeaways

• Major global suppliers include Mitsubishi Tanabe (original developer), Teva, Dr. Reddy’s, Sun Pharma, and Aurobindo.
• API sourcing predominantly occurs in China and India, with quality and regulatory compliance critical for supply security.
• Supply chain vulnerabilities include patent challenges, geopolitical tensions, regulatory variability, and raw material shortages.
• Diversification and technological innovation are central to ensuring resilient supplies of Felodipine.
• Stakeholders should engage with reliable, GMP-compliant manufacturers and monitor regulatory landscapes to sustain supply chain stability.

FAQs

1. Who are the leading global manufacturers of Felodipine?
Major producers include Mitsubishi Tanabe Pharma (original patent holder), Teva Pharmaceutical Industries, Dr. Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma, with many of these also serving as generic suppliers.

2. In which countries are API suppliers for Felodipine primarily located?
API production predominantly occurs in China and India, leveraging cost advantages and high manufacturing capacity, followed by smaller European-based suppliers adhering to strict quality standards.

3. How do patent protections affect the Felodipine supply chain?
Patent protections can limit generic production in certain jurisdictions, but patent expirations in many markets have opened access for generic manufacturers, increasing supply options.

4. What supply chain challenges impact Felodipine availability?
Key challenges include raw material shortages, geopolitical trade restrictions, regulatory compliance issues, manufacturing capacity constraints, and disruptions caused by global health crises.

5. What strategies can stakeholders use to mitigate Felodipine supply risks?
Diversification of suppliers, investing in local manufacturing, maintaining regulatory compliance, and building strategic stockpiles are critical to enhancing supply chain resilience.

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Sources:

[1] U.S. Food and Drug Administration (FDA). "Drug Approvals and NDA Information." FDA, 2022.
[2] IQVIA. "The Global Use of Medicines in 2022." IQVIA Institute, 2022.
[3] European Medicines Agency (EMA). "Pharmacovigilance and Marketing Authorization." EMA, 2022.
[4] GlobalData. "Pharmaceutical Market Insights," 2022.
[5] Industry reports on API manufacturing and global pharmaceutical supply chains.