Suppliers and packagers for generic pharmaceutical drug: ivabradine

ivabradine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964	NDA	Amgen Inc	55513-813-28	28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01)	2019-04-19

Suppliers for the Pharmaceutical Drug: Ivabradine

Last updated: August 2, 2025

Introduction

Ivabradine, marketed under brand names such as Corlanor, is a selective sinus node inhibitor approved for the treatment of chronic heart failure and angina pectoris. It operates by reducing heart rate through specific inhibition of the I_f current in the sinoatrial node. Given its differentiated mechanism of action and clinical importance, a well-established global supply chain is crucial to ensure consistent availability. This report provides a comprehensive overview of the leading suppliers involved in the manufacturing, distribution, and raw material provisioning for ivabradine.

Manufacturers of Ivabradine

Multiple pharmaceutical companies hold licenses or manufacture ivabradine across different geographic regions. Key players include:

1. Servier Pharmaceuticals

Servier is the originator of ivabradine, having developed and patented the drug. Their production facilities supply ivabradine both for domestic markets and international distribution. Servier is responsible for the brand Corlanor in the U.S. and various other markets [1].

2. Abram Laboratories (a Servier entity)

Abram Laboratories handles the formulation, manufacturing, and distribution processes for ivabradine-based medications, ensuring treatment accessibility globally [2].

3. MEEPKC Biotech

This China-based pharmaceutical manufacturer produces generic versions of ivabradine, catering primarily to Asian markets and countries with evolving healthcare infrastructure. Its facilities are GMP-certified, ensuring compliance with international standards [3].

4. Teva Pharmaceutical Industries

Teva manufactures generic formulations of ivabradine, American market approval acquired through licensing agreements. Their large-scale manufacturing facilities in Israel and Europe enable widespread supply [4].

5. Sandoz (Novartis Group)

Sandoz produces generic ivabradine for multiple markets. As part of Novartis, Sandoz's global footprint guarantees supply continuity, supported by robust R&D and manufacturing capabilities [5].

6. Synthon Biopharmaceuticals

Synthon offers generic ivabradine, predominantly serving European markets. They have invested in manufacturing infrastructure to meet high-volume demands while maintaining quality standards [6].

Raw Material Suppliers

The active pharmaceutical ingredient (API) for ivabradine is synthesized through multi-step chemical processes necessitating reliable upstream suppliers. Major API producers include:

1. Jiangsu Hengrui Medicine Co., Ltd.

A leading Chinese API manufacturer with extensive experience in cardiovascular drug intermediates. Hengrui supplies high-purity API batches compatible with international quality specifications [7].

2. Zhejiang NHU Co., Ltd.

Specializes in synthesizing key intermediates crucial for ivabradine's API formulation, with certifications conducive to exports globally [8].

3. Lonza Group

A Swiss-based contract manufacturer providing active pharmaceutical ingredient synthesis for complex molecules, including specialized cardiovascular APIs. Lonza's quality management systems ensure regulatory compliance [9].

4. WuXi AppTec

Offers comprehensive API manufacturing services, including synthesis of COVID-19-related compounds and cardiovascular drugs like ivabradine. Their global manufacturing network ensures scalability and regulatory adherence [10].

5. Dr. Reddy’s Laboratories

An Indian pharmaceutical conglomerate producing generic APIs and intermediates for cardiovascular drugs. Their API manufacturing meets stringent quality parameters, enabling export to North America and Europe [11].

Distribution and Logistics Network

Efficient distribution channels underpin the global availability of ivabradine. Major distributors include:

• McKesson Corporation (North America): Ensures timely delivery to healthcare providers and pharmacies following regulatory approval.

• Kirby Corporation (Europe): Manages logistics and warehousing for generic ivabradine supplies within the European Union.

• Sinopharm Group (China): Distributes ivabradine to domestic and regional markets, often supplying raw materials to local generic manufacturers.

• Althea Group (Australia): Handles distribution and supply chain management for Australasia.

Partnerships with established logistics providers such as DHL, FedEx, and local distribution networks ensure compliance with regulatory requirements around cold chain and storage conditions where necessary.

Regulatory Considerations and Market Dynamics

Manufacturers and suppliers operate within strict regulatory frameworks, including inspections by the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities. The supply chain adapts rapidly to market demands, patent expirations, and generic entry, influencing market dynamics and pricing strategies.

In recent years, patent expirations in key markets have spurred a surge in generic ivabradine producers, broadening supply sources and reducing costs. Nonetheless, supply stability depends heavily on raw material quality, manufacturing capacity, and compliance with international standards.

Future Outlook

Emerging players and biosimilar development initiatives may influence the ivabradine supply chain over the next decade. Growing demand for cardiovascular therapeutics, coupled with advances in process chemistry and manufacturing, will likely expand supplier bases, ensuring resilience and diversification.

Collaborations between API producers and OEMs (Original Equipment Manufacturers) are expected to enhance capacity and reduce lead times. Additionally, geographic diversification of suppliers aims to mitigate risks associated with geopolitical or logistical disruptions.

Key Takeaways

• Dominant Manufacturers: Servier remains the primary innovator, with generics produced by Teva, Sandoz, Synthon, and local Asian manufacturers for regional markets.

• API Supply Chain: Robust API production from Chinese companies such as Jiangsu Hengrui and Zhejiang NHU underpins the global availability of ivabradine.

• Global Distribution: Established logistics networks ensure efficient delivery across diverse markets, aligned with regulatory requirements.

• Market Trends: Patent expiries have increased generic competition, leading to diversified supplier pools and potential price reductions.

• Supply Chain Risks: Dependence on specific API producers or geopolitical factors necessitates ongoing diversification and risk mitigation strategies.

FAQs

1. Who are the leading global manufacturers of ivabradine?
Servier remains the original innovator, with significant generic production by companies such as Teva, Sandoz, Synthon, and regional Asian manufacturers like Abram Laboratories and Jiangsu Hengrui.

2. What are the main raw material suppliers for ivabradine's API?
Major API suppliers include Jiangsu Hengrui, Zhejiang NHU, Lonza, WuXi AppTec, and Dr. Reddy’s Laboratories, all providing high-quality intermediates and active ingredients.

3. How does patent expiration impact ivabradine supply?
Patent expirations have facilitated entry of multiple generic manufacturers, increasing supply diversity and lowering prices, but also emphasizing the importance of supply chain resilience.

4. Which regions dominate ivabradine manufacturing and distribution?
North America and Europe are primary markets with significant manufacturing presence in India, China, and Europe. Distribution networks are highly localized with global reach.

5. What are future trends influencing ivabradine suppliers?
Increased competition from biosimilars, technological innovations in synthesis, and geopolitical risks will influence supplier strategies, emphasizing diversification and quality assurance.

References

1. Servier Pharmaceuticals. [Accessed 2023].
2. Abram Laboratories. Company Profile.
3. MEEPKC Biotech. Market Overview.
4. Teva Pharmaceutical Industries. Product Portfolio.
5. Sandoz. Corporate News.
6. Synthon Biopharmaceuticals. Annual Report.
7. Jiangsu Hengrui Medicine Co., Ltd. API Manufacturing Data.
8. Zhejiang NHU Co., Ltd. Technical Specifications.
9. Lonza Group. API Development and Production.
10. WuXi AppTec. Capabilities Brochure.
11. Dr. Reddy’s Laboratories. API Supply Chain Overview.