Suppliers and packagers for generic pharmaceutical drug: vericiguat

vericiguat

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377	NDA	Merck Sharp & Dohme LLC	0006-5028-01	14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-01)	2021-02-01
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377	NDA	Merck Sharp & Dohme LLC	0006-5028-02	30 TABLET, FILM COATED in 1 BOTTLE (0006-5028-02)	2021-02-01
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377	NDA	Merck Sharp & Dohme LLC	0006-5028-04	10 BLISTER PACK in 1 CARTON (0006-5028-04) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0006-5028-03)	2021-02-01

Suppliers for the Pharmaceutical Drug: Vericiguat

Last updated: July 27, 2025

Introduction

Vericiguat is an innovative pharmaceutical agent developed by Bayer AG, marketed under the brand name Verquvo. It is approved primarily for the treatment of chronic heart failure with reduced ejection fraction (HFrEF), particularly in patients who have recently experienced worsening of their condition. As a soluble guanylate cyclase (sGC) stimulator, vericiguat enhances cyclic guanosine monophosphate (cGMP) production, resulting in vasodilation and improved cardiac function. Given its significance in managing advanced cardiac failure, understanding the supply chain and key suppliers of vericiguat becomes critical for healthcare providers, distributors, and pharmaceutical stakeholders.

This analysis offers a comprehensive overview of the primary suppliers involved in the manufacturing, sourcing, and distribution of vericiguat, along with insights into the geopolitical, logistical, and manufacturing nuances influencing its availability.

Manufacturing and Supply Chain Overview

Bayer AG: The Original Manufacturer

Bayer AG is the original innovator and patent holder for vericiguat. The company's integrated R&D, manufacturing, and distribution infrastructure centrally position it as the primary supplier. Bayer's global manufacturing facilities, located predominantly in Europe and North America, are equipped to produce high-quality pharmaceutical compounds, including vericiguat, adhering to stringent Good Manufacturing Practice (GMP) standards (Bayer Corporate Reports, 2022).

Active Pharmaceutical Ingredient (API) Production

The production of vericiguat's API is complex, requiring advanced chemical synthesis and strict quality controls. Bayer likely synthesizes its API in-house, leveraging proprietary processes, or collaborates with specialized third-party API producers. Since large-scale API manufacturing often involves multiple tiers of suppliers, Bayer may source certain intermediates or raw materials from contract manufacturers in Asia, Europe, or North America.

Formulation and Finished Dosage Production

Bayer handles the formulation of vericiguat into tablets and packaging at its certified pharmaceutical manufacturing facilities. This integrated approach ensures quality control and regulatory compliance. Bayer's global manufacturing network allows for distribution across continents, though the bulk of the supply chain remains concentrated within its own facilities or trusted domestic contract manufacturing organizations (CMOs).

Key Suppliers in the Vericiguat Supply Chain

1. Raw Material Suppliers

The core raw materials for vericiguat synthesis include specialized chemicals used to generate the active molecule. These come predominantly from chemical suppliers in Asia (China, India), Europe, and North America. Such suppliers include:

• Sigma-Aldrich (Merck Group): Provides high-purity chemicals and intermediates used in API synthesis [1].
• Thermo Fisher Scientific: Supplies chemicals and lab reagents essential for process development and manufacturing [2].
• Alfa Aesar (Thermo Fisher): Offers key raw materials with specifications suitable for pharmaceutical synthesis [3].

2. Active Pharmaceutical Ingredient (API) Manufacturers

While Bayer is the primary producer, certain high-volume API producers with capacity for complex synthesis may supply intermediates or finished API to Bayer or third-party manufacturers. These include:

• HISUN Pharmaceutical (China): A major player in complex API synthesis, including innovative selective synthesis techniques.
• Jubilant Life Sciences (India): Provides API manufacturing services for various cGMP-compliant products, possibly including links in vericiguat's manufacturing chain.
• Lubrizol Advanced Materials (USA): Supplies specialized reagents or intermediates potentially involved in synthesis pathways.

3. Contract Manufacturing Organizations (CMOs)

Bayer may engage CMOs for certain aspects of formulation, packaging, or extensive API production. Notable CMOs involved in high-volume pharmaceutical manufacturing include:

• Patheon (Thermo Fisher Scientific): Known for large-scale formulation and packaging services.
• Samsung Biologics: While primarily biologics-focused, Samsung also offers chemical manufacturing facilities.
• Recipharm: Provides formulation and fill-finish services across Europe and North America.

4. Packaging and Distribution Suppliers

Primary packaging materials (blisters, bottles, cartons) are supplied by companies such as:

• Amcor: Offers pharmaceutical-grade packaging materials compliant with regulatory standards.
• West Pharmaceutical Services: Supplies containment systems essential for preventing contamination.

Post-production, Bayer distributes vericiguat directly to healthcare authorities, wholesalers, and pharmacies. However, in certain regions, third-party logistics providers facilitate distribution.

Geopolitical and Regulatory Considerations

The global supply chain for vericiguat faces vulnerabilities, particularly stemming from geopolitical tensions, trade restrictions, and dependency on Asian API producers. In recent years, strains on supply chains due to COVID-19 have accentuated the importance of diversifying suppliers and establishing strategic inventories. Bayer's supply chain management emphasizes dual-sourcing and regional manufacturing to mitigate risks.

Regulatory compliance with agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japanese Pharmaceuticals and Medical Devices Agency) influences sourcing and quality assurance standards for all suppliers.

Challenges in the Vericiguat Supply Chain

• Chemical Synthesis Complexity: The intricate synthesis pathways of vericiguat demand specialized production processes, limiting the number of qualified API producers.
• Raw Material Scarcity: Limited availability of intermediates due to manufacturing capacity constraints or trade restrictions.
• Regulatory Hurdles: Variations in approval processes across jurisdictions can delay manufacturing scale-up or supply continuity.
• Supply Chain Disruptions: Political instability, pandemics, and transportation issues can impact timely delivery of raw materials and finished products.

Future Directions and Supply Chain Optimization

To enhance resilience, Bayer and stakeholders are exploring regional API manufacturing facilities, strategic stockpiles, and supply chain digitization. Partnerships with local CMOs and raw material suppliers are actively being negotiated to diversify sources and reduce dependency on single regions.

Key Takeaways

• Bayer AG is the main producer of vericiguat, with auxiliary supply chains involving raw material suppliers and contract manufacturers.
• The supply chain is concentrated geographically, with significant reliance on Asian suppliers for raw materials, posing potential risks.
• Regulatory compliance and quality standards are fundamental in selecting and managing suppliers within the vericiguat manufacturing ecosystem.
• Disruptions in raw material supply, geopolitical tensions, and manufacturing complexities can impact drug availability.
• Strategic diversification and regional manufacturing investments are critical to ensuring steady supply.

FAQs

1. Who are the primary API suppliers for vericiguat?
Bayer primarily manufactures vericiguat in-house but may source intermediates from established API producers in China, India, and Europe such as Jubilant Life Sciences and HISUN Pharmaceutical.

2. What role do contract manufacturing organizations play in the vericiguat supply chain?
CMOs assist in formulation, packaging, and sometimes API synthesis, enabling Bayer to expand manufacturing capacity and regional distribution channels.

3. Are there any alternative suppliers to Bayer for vericiguat?
Currently, Bayer holds the patent and primary manufacturing rights, making it the main supplier. However, authorized generic manufacturers may emerge post-patent expiration.

4. How vulnerable is the vericiguat supply chain?
Supply chains are susceptible to geopolitical risks, raw material shortages, and logistical disruptions, emphasizing the need for diversified sourcing strategies.

5. Is there potential for regional manufacturing of vericiguat?
Yes, investment in regional API and formulation facilities by Bayer and partners aims to reduce dependency on centralized production hubs, increasing supply resilience.

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References

[1] Sigma-Aldrich Corporate Website, 2022.
[2] Thermo Fisher Scientific, Pharmaceutical Chemicals Portfolio, 2022.
[3] Alfa Aesar Product Line, 2022.