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Suppliers and packagers for VERELAN
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VERELAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | VERELAN | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019614 | NDA | Teva Pharmaceuticals Inc | 0591-2880-01 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2880-01) | 1990-05-29 |
| Azurity | VERELAN | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019614 | NDA | Teva Pharmaceuticals Inc | 0591-2882-01 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2882-01) | 1990-05-29 |
| Azurity | VERELAN | verapamil hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019614 | NDA | Teva Pharmaceuticals Inc | 0591-2884-01 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2884-01) | 1990-05-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Verelan
Introduction
Verelan, a proprietary brand name for the treatment of hypertension and angina, contains the active ingredient verapamil hydrochloride, a calcium channel blocker. As a well-established medication, Verelan has a broad distribution network, including both branded and generic suppliers. Ensuring supply chain resilience, regulatory compliance, and cost efficiency demands a comprehensive understanding of current primary suppliers and manufacturing sources. This article provides an in-depth overview of key suppliers of Verelan and related verapamil hydrochloride, offering insights into market dynamics and strategic considerations for stakeholders.
Overview of Verelan and Its Market Position
Verelan is marketed primarily by brands such as Abbott Laboratories (now part of AbbVie), which holds a significant share in the calcium channel blocker segment. The drug’s formulation allows for sustained-release and immediate-release variants, with manufacturing roles distributed across multiple geographies. As patent protections have expired, the drug is now widely available as a generic, expanding the supplier base but also intensifying competition and supply chain complexity.
Active Pharmaceutical Ingredient (API) Suppliers for Verelan
The core of Verelan’s supply chain hinges on reliable verapamil hydrochloride API sources. Several manufacturers globally produce verapamil API, with key origins including China, India, and Western manufacturing hubs. The following sections highlight leading API suppliers and the associated manufacturing landscape.
Leading API Manufacturers of Verapamil Hydrochloride
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Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Hisun Pharmaceutical is among the prominent Chinese manufacturers producing verapamil hydrochloride API. Known for its extensive portfolio of cardiovascular APIs, Hisun’s facilities adhere to Good Manufacturing Practices (GMP), ensuring quality compliance for global markets. The company supplies both domestic Chinese buyers and international partners, notably API intermediaries and generic drug producers. -
Covalent Laboratories (India)
Covalent Laboratories specializes in the manufacture of cardiovascular APIs, including verapamil hydrochloride. Their large-scale facilities in India operate under stringent quality standards, serving a broad client base across North America and Europe. Covalent’s focus on cost-effective production combined with robust regulatory adherence makes it a key player in the API supply chain. -
Hubei Order Pharma Co., Ltd. (China)
Hubei Order Pharma offers verapamil hydrochloride API to global markets, emphasizing high purity levels critical for pharmaceutical formulations. Their proprietary synthesis methods and quality assurance protocols position them as a reliable supplier for branded and generic drug manufacturers. -
Golden Sunshine (India)
Golden Sunshine is another Indian API manufacturer with an emphasis on cardiovascular drug APIs. They have achieved compliance with international quality standards, including WHO GMP, strengthening their position as a credible source for verapamil API. -
Other Notable API Manufacturers
- Sino-american Tianjin Corporation (China)
- Aurobindo Pharma Ltd. (India)
- Jubilant Life Sciences (India)
These companies globally contribute to the manufacturing capacity for verapamil API, fulfilling both regional and export demands.
Branded Verelan Manufacturing and Supply Channel
Original branded Verelan formulations are primarily produced by Abbott Laboratories, with manufacturing facilities distributed across North America, Europe, and Asia. Abbott’s control over key production sites ensures consistency and compliance with regulatory standards such as FDA and EMA. The proprietary manufacturing process grants Abbott a competitive edge for the brand but also limits supply chain flexibility compared to generic manufacturers.
Generic and Marketed Verapamil Hydrochloride Products
In the wake of patent expirations, numerous pharmaceutical companies have entered the market offering generic verapamil hydrochloride tablets and capsules. These generics are supplied by a broad array of domestic and international manufacturers, often utilizing the APIs produced by the aforementioned suppliers. Notable companies include:
- Sandoz (Novartis Group)
- Teva Pharmaceutical Industries
- Mylan (now part of Viatris)
- Aurobindo Pharma
- Sun Pharmaceutical Industries
These companies utilize APIs from Chinese and Indian manufacturers, often through importation and local formulation in their respective manufacturing plants.
Supply Chain Challenges and Strategic Considerations
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Regulatory Compliance
Suppliers must meet rigorous standards, especially for APIs intended for markets with stringent regulations such as the US (FDA) and EU (EMA). Ensuring traceability, rigorous testing, and GMP adherence remain critical for supplier selection. -
Quality Variability
While Chinese API manufacturers offer cost advantages, variability in quality and regulatory oversight can pose risks. Indian API producers, with notable GMP certifications, often serve as a more compliant alternative, albeit at a higher cost. -
Geopolitical Risks
Over-reliance on API suppliers from China and India exposes supply chains to geopolitical and trade disruptions, which necessitates diversification strategies and dual sourcing. -
Supply Security and Cost Dynamics
The rise of regional manufacturing hubs and the push for onshore or nearshore production for critical drugs motivate companies to develop local supplier relationships. Cost competitiveness remains essential but is increasingly balanced with quality assurance.
Emerging Trends in Verelan Supplier Market
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Increased Regulatory Scrutiny
The US FDA and EMA have intensified their oversight of API manufacturing facilities, leading to more stringent audits and potential supply disruptions. -
API Manufacturing Innovation
Novel synthetic routes and process intensification aim to improve yields, purity, and environmental sustainability, influencing supplier offerings. -
Strategic Partnerships and Alliances
Pharmaceutical companies are forming alliances to secure reliable API supplies, including long-term contracts with Chinese and Indian manufacturers or licensing agreements with regional producers.
Conclusion
The supply landscape for Verelan involves a diversified array of API manufacturers predominantly based in China and India. Leading suppliers such as Zhejiang Hisun and Covalent Laboratories play crucial roles, providing high-quality verapamil hydrochloride APIs that underpin both branded and generic Verelan products. Pharmaceutical companies must navigate regulatory standards, quality considerations, geopolitical risks, and cost factors to establish resilient supply chains for this essential cardiovascular medication. Strategic supplier engagement, rigorous quality compliance, and diversification are vital for ensuring continuous market supply.
Key Takeaways
- Verelan’s API is primarily supplied by Chinese and Indian manufacturers, with Zhejiang Hisun and Covalent Laboratories leading in volume and quality.
- Post-patent generic markets have expanded supplier options, increasing competition but also complicating supply chain management.
- Regulatory compliance and quality assurance are critical criteria for supplier selection, especially for markets with stringent standards.
- Geopolitical risks necessitate diversification strategies, including sourcing from multiple regions and developing local manufacturing.
- Technological innovations in API synthesis and evolving regulatory frameworks are shaping future supplier landscapes.
FAQs
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Who are the top global suppliers of verapamil hydrochloride API?
The leading API suppliers include Zhejiang Hisun Pharmaceutical (China), Covalent Laboratories (India), Hubei Order Pharma (China), and Golden Sunshine (India), among others. -
How does the regulatory landscape impact Verelan API sourcing?
Rigorous compliance with GMP and good manufacturing practices mandated by agencies such as the FDA and EMA influence supplier selection, emphasizing quality and traceability standards. -
Are there risks associated with sourcing from Chinese API manufacturers?
Yes. Potential risks include regulatory compliance variability, geopolitical tensions, and trade restrictions. Diversifying suppliers can mitigate these risks. -
What role do Indian manufacturers play in the Verelan supply chain?
Indian manufacturers like Covalent and Aurobindo are integral, offering cost-effective, GMP-compliant APIs that support both generic and branded Verelan formulations. -
What trends are shaping future Verelan API supply strategies?
Trends include increased regulatory scrutiny, technological advances in API synthesis, focus on supply chain resilience, and regional manufacturing expansion.
Sources
- U.S. Food and Drug Administration (FDA). Drug Master Files and API Supplier Data.
- GlobalData. API Market Reports for Cardiovascular Drugs.
- Company websites: Zhejiang Hisun, Covalent Laboratories, Hubei Order Pharma, Golden Sunshine.
- Pharmaceutical Industry Reports on API Manufacturing and Supply Chain Dynamics.
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