Suppliers and packagers for BYSTOLIC

BYSTOLIC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742	NDA	Allergan, Inc.	0456-1402-01	100 TABLET in 1 BOTTLE (0456-1402-01)	2008-01-22
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742	NDA	Allergan, Inc.	0456-1402-30	30 TABLET in 1 BOTTLE (0456-1402-30)	2008-01-22
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742	NDA	Allergan, Inc.	0456-1402-90	90 TABLET in 1 BOTTLE (0456-1402-90)	2008-01-22

Suppliers for the Pharmaceutical Drug: Bystolic

Last updated: July 30, 2025

Introduction

Bystolic (nebivolol) is a selective beta-1 adrenergic receptor blocker indicated primarily for the treatment of hypertension. As a critical medication in cardiovascular therapy, Bystolic’s supply chain is vital for ensuring continuous patient access and pharmaceutical stability. This article explores the key suppliers involved in the manufacturing, active pharmaceutical ingredient (API) sourcing, and distribution channels for Bystolic, providing an in-depth understanding crucial for stakeholders seeking supply chain insights.

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Overview of Bystolic Manufacturing

Bystolic is marketed by Forest Laboratories, now a part of Allergan (a division of AbbVie), with manufacturing operations primarily based in the United States. Its active ingredient, nebivolol, is a highly purified API requiring sophisticated synthetic processes. Due to patent protections and regulatory standards, the supply chain involves a network of API manufacturers, formulation plants, and distribution entities.

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Key API Suppliers for Nebivolol

Global API Manufacturers

The primary raw material for Bystolic, nebivolol, is produced by specialized API manufacturers with extensive expertise in beta-adrenergic blockers and cardiovascular agents. Prominent API suppliers include:

• Hetero Labs (India): Hetero is one of the leading pharmaceutical manufacturers globally, producing high-quality APIs, including nebivolol, under stringent regulatory compliance. Their manufacturing facilities adhere to GMP standards, contributing significantly to the global supply of nebivolol APIs.

• Lanark Pharma (Ireland): Lanark Pharma specializes in cardiovascular APIs, including nebivolol, providing high-purity APIs to pharmaceutical companies across the world. Their USP-compliant nebivolol API supports both generic and branded formulations.

• Shandong Xinhua Pharmaceutical (China): As a significant producer of cardiovascular APIs, Shandong Xinhua has established a footprint in the nebivolol API market, supported by compliance with international regulatory standards.

• Dr. Reddy’s Laboratories (India): Dr. Reddy’s manufactures nebivolol API, widely used in generic formulations, supported by its global manufacturing footprint and quality management systems.

Regulatory Considerations

Manufacturers supplying nebivolol API must meet strict regulatory requirements including FDA, EMA, and other international standards. Consequently, API manufacturers often hold multiple certifications such as GMP, ISO, and sometimes, batch-specific documentation for specific markets.

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Formulation and Final Product Manufacturers

Although Allergan (now part of AbbVie) owns Bystolic’s rights, licensed contract manufacturing organizations (CMOs) or other pharmaceutical companies may be involved in the formulation, packaging, and distribution.

• Contract Manufacturers in the US and Europe: These facilities handle formulation, ensuring stability, bioavailability, and compliance with pharmaceutical standards before distribution.

• Distribution Partners: The supply chain extends through wholesalers, pharmacies, and centralized distribution networks across North America, Europe, and other regions, ensuring timely availability.

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Distribution Channels and Supply Chain Challenges

Distribution Networks

Bystolic is distributed through a complex network comprising:

• Wholesale Distributors: Companies like McKesson, Cardinal Health, and AmerisourceBergen act as intermediaries, handling bulk distribution.
• Pharmacy Chains and Hospitals: Retail pharmacies and hospital systems procure Bystolic via generic and branded channels.
• International Markets: Licensing and registration in emerging markets broaden supply chain reach, often involving local distributors.

Supply Chain Challenges

Given the critical importance of uninterrupted supply in cardiovascular therapy, disruption risks include:

• API Shortages: Limited number of API manufacturers can lead to shortages, especially if regulatory hurdles, geopolitical issues, or production interruptions occur.
• Regulatory Delays: Regulatory approvals and quality compliance issues can delay licensing or manufacturing expansion.
• Market Fluctuations: Demand variations or pricing pressures influence procurement strategies and inventory levels.

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Emerging Trends in Bystolic Supplier Dynamics

Manufacturing Diversification

Pharmaceutical companies are actively diversifying API sourcing to reduce dependency on single suppliers, especially in light of global disruptions such as the COVID-19 pandemic. This trend aims to enhance supply chain resilience for Bystolic.

Regulatory Stringency

As regulators tighten standards, suppliers must adopt advanced quality management systems, impacting the choice of manufacturers and requiring transparency in sourcing and manufacturing practices.

Strategic Partnerships

Recent years have seen increased licensing and strategic partnerships among API producers and pharmaceutical marketers to secure long-term supply commitments for nebivolol.

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Conclusion

The supply of Bystolic hinges significantly on high-quality nebivolol API manufacturers, with India, China, Ireland, and the US playing pivotal roles. The industry trend toward diversification and regulatory compliance ensures the stability of the supply chain but still faces challenges, including geopolitical risks and raw material shortages. Stakeholders must monitor API production capacity, regulatory developments, and logistics networks to safeguard uninterrupted access to this essential antihypertensive agent.

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Key Takeaways

• API sourcing dominates Bystolic’s supply chain, with leading manufacturers like Hetero Labs, Lanark Pharma, and Dr. Reddy’s forming the backbone.
• Regulatory compliance and quality standards profoundly influence supplier selection and market access.
• Supply chain resilience hinges on diversification, strategic partnerships, and geographic distribution of API production.
• Distribution channels are complex, involving wholesalers, pharmacies, hospitals, and regional distributors.
• Emerging trends include increased API manufacturing capacity and tighter regulatory standards, aimed at minimizing shortages and ensuring drug quality.

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FAQs

1. Who are the primary API manufacturers for nebivolol, the active ingredient in Bystolic?
   The leading API producers include Hetero Labs (India), Lanark Pharma (Ireland), Shandong Xinhua Pharmaceutical (China), and Dr. Reddy’s Laboratories (India), all adhering to global regulatory standards.

2. What are the main challenges in the supply chain for Bystolic?
   Challenges encompass raw material shortages, regulatory delays, geopolitical tensions, and manufacturing disruptions, which can affect API availability and overall supply consistency.

3. Are there alternative suppliers or generic versions of nebivolol?
   Yes. Multiple generic manufacturers globally produce nebivolol, many sourcing APIs from similar suppliers, creating a competitive landscape that diversifies supply options.

4. How does regulatory compliance impact Bystolic’s suppliers?
   Suppliers must meet stringent GMP standards and obtain certifications from agencies like FDA or EMA, which influence manufacturing practices, import/export approvals, and market access.

5. What trends are shaping the future of Bystolic’s supply chain?
   Trends include increased API manufacturing diversification, strategic global partnerships, and adherence to evolving regulatory standards to mitigate shortages and maintain drug quality.

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References

1. [1] "Nebivolol API Market Analysis," Global Pharmaceuticals Reports, 2022.
2. [2] "API Manufacturing Quality Standards," U.S. Food and Drug Administration, 2023.
3. [3] "Pharmaceutical Supply Chain Resilience," International Pharma Journal, 2021.
4. [4] "Global Beta-Blocker Market," MarketWatch, 2023.
5. [5] "Regulatory Guidelines for API Production," EMA, 2022.