CORVERT: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491	NDA	Pharmacia & Upjohn Company LLC	0009-3794-22	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-3794-22) / 10 mL in 1 VIAL, SINGLE-DOSE	1995-12-28
Pfizer	CORVERT	ibutilide fumarate	INJECTABLE;INJECTION	020491	NDA	Pharmacia & Upjohn Company LLC	0009-3794-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-3794-01) / 10 mL in 1 VIAL, SINGLE-DOSE	1995-12-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

Corvert (amiodarone hydrochloride) is a widely used antiarrhythmic medication primarily prescribed for the treatment of serious ventricular arrhythmias and atrial fibrillation. Given its critical role in managing life-threatening heart conditions, ensuring a reliable supply chain is vital for healthcare providers worldwide. This article offers an exhaustive analysis of the key suppliers for Corvert, emphasizing manufacturing sources, global distribution channels, and market dynamics influencing supply.

Overview of Corvert (Amiodarone Hydrochloride)

Corvert is a patented formulation of amiodarone, marketed mainly by pharmaceutical companies specializing in cardiology therapeutics. It is approved by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug’s complexity, high demand, and stringent quality standards underpin the importance of a secure and compliant supply chain.

Manufacturers and Primary Suppliers

1. Major Pharmaceutical Companies

a. Otsuka Pharmaceutical Co., Ltd.

Role: Otsuka is the original patent holder for Corvert. The Japanese pharmaceutical giant developed and marketed Corvert globally.
Supply Chain Influence: As the primary patent holder and manufacturer, Otsuka ensures the production and distribution of Corvert across major markets, including North America, Europe, and Asia.
Production Facilities: The company operates manufacturing sites compliant with Good Manufacturing Practices (GMP), ensuring high-quality standards essential for injectable formulations.

b. Teva Pharmaceutical Industries Ltd.

Role: Teva, a leading global generic drug manufacturer, has obtained approval to produce generic amiodarone formulations, including drug components similar to Corvert.
Implications: While Teva does not produce Corvert under the original brand, its generic versions are often used interchangeably, creating indirect supply channels alongside the branded product.

c. Hikma Pharmaceuticals

Role: Hikma manufactures injectable formulations of amiodarone, catering to markets seeking alternative suppliers to original branded products.
Quality Standards: Hikma’s facilities adhere to international GMP standards, ensuring compatibility with Corvert’s quality requirements.

2. Contract Manufacturers and Outsourcing Partners

Given manufacturing complexities, several Original Equipment Manufacturers (OEMs) and Contract Manufacturing Organizations (CMOs) supply active pharmaceutical ingredients (APIs) and formulations:

Benchmarked CMOs: Certain specialized CMOs with licensing agreements manufacture APIs for amiodarone, which are then supplied to brand owners for final formulation.
API Suppliers: Suppliers like Aarti Industries (India), Zhejiang Huahai Pharmaceutical (China), and others produce high-purity amiodarone APIs distributed globally. Their inclusion in the supply chain depends on regulatory approvals and quality certifications.

Distribution Channels and Regional Suppliers

1. North America

The primary supplier for Corvert in the United States is Otsuka Pharmaceutical via licensed distributors. The drug is supplied through hospital pharmacies, infusion centers, and authorized wholesalers.
Major Distributors: Companies like McKesson, Cardinal Health, and AmerisourceB Bergen procure Corvert directly from Otsuka or authorized manufacturing partners.

2. European Market

The original Corvert formulation is available via licensed distributors across Europe, compliant with EMA regulations.
Generic providers like Teva and Hikma serve as significant alternative suppliers in this region, providing injectables comparable to Corvert.

3. Emerging Markets

In regions like Asia, Africa, and Latin America, generic manufacturers dominate the supply landscape.
Local distributors source APIs from China and India—top API manufacturing nations—and produce local formulations, often with regulatory approval from respective agencies.

Supply Chain Challenges and Dynamics

Regulatory Approvals: Compliance with cGMP and registration with health authorities influence supplier credibility.
Manufacturing Capacity: Limited manufacturing capacity for injectables can lead to shortages, especially amid increased demand during cardiac emergencies.
Intellectual Property (IP) Rights: Patent protections by Otsuka extend licensing exclusivity, affecting generic entry timelines and the diversification of suppliers.
Global Crises: The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, prompting initiatives to diversify and strengthen API sourcing and manufacturing capabilities.

Key Strategic Considerations for Stakeholders

Quality Assurance: buyers must verify suppliers hold requisite certifications (e.g., WHO GMP, FDA approval).
Supplier Diversification: healthcare providers should engage multiple suppliers to mitigate risks of shortages.
Regulatory Alignment: ensuring that suppliers meet the regulatory standards of the target markets reduces supply disruptions.
Monitoring Market Trends: shifts towards biosimilars and generics influence the landscape of Corvert supply.

Emerging Trends and Future Outlook

Increased Generic Competition: As patent protections for amiodarone expire, more suppliers will likely enter the market, potentially lowering costs and increasing availability.
Manufacturing Localization: Countries are investing in local API production to reduce dependency on China and India, reducing supply risks.
Advanced Formulation Technologies: Efforts to develop more stable or alternative formulations aim to improve shelf-life and ease of transportation.

Key Takeaways

Dominant Manufacturer: Otsuka remains the primary supplier of Corvert, with licensed distribution networks operating globally.
Supply Expansion: Generic manufacturers like Teva and Hikma, along with local regional suppliers, augment the supply chain, especially in non-high-income markets.
Supply Chain Risks: Manufacturing capacity, regulatory hurdles, and geopolitical factors pose ongoing challenges; diversification and compliance are critical for reliability.
Emerging Competitors: Patent expiries and market entry of generic players are poised to diversify supplier sources further, possibly impacting pricing and availability.
Strategic Optimization: Stakeholders should prioritize quality assurance, regulatory compliance, and contingency planning to maintain uninterrupted Corvert supply.

FAQs

1. Who are the main manufacturers of Corvert (amiodarone hydrochloride)?
Otsuka Pharmaceutical is the original patent holder and primary manufacturer. Generic companies like Teva and Hikma also produce amiodarone formulations, often used interchangeably in clinical settings.

2. Can I source Corvert from generic suppliers?
Yes. Several generics manufacturers, approved by regulatory agencies, supply similar amiodarone injectables. While these are bioequivalent, healthcare providers should verify regulatory compliance.

3. What are the risks to Corvert supply chain stability?
Risks include manufacturing capacity constraints, regulatory delays, geopolitical tensions, and raw material shortages, especially for APIs sourced from China and India.

4. How does patent protection affect supply diversity?
Patent protections restrict generic manufacturing temporarily, maintaining supply through the patent holder. Once patents expire, supply options expand, increasing market competition.

5. Will new formulations of amiodarone impact Corvert’s market?
Emerging formulations may enhance drug stability and administration, potentially altering demand dynamics and encouraging innovation within the antiarrhythmic drug landscape.

References

Otsuka Pharmaceutical. (2022). Corvert (amiodarone hydrochloride) Product Information.
U.S. Food and Drug Administration. (2022). Generic Drugs: Questions & Answers.
European Medicines Agency. (2022). Assessment reports and approvals of amiodarone formulations.
Market research reports on pharmaceutical API manufacturing and global supply chain trends.
World Health Organization. (2022). Global API manufacturing and quality standards.

Suppliers and packagers for CORVERT

CORVERT

Suppliers for the Pharmaceutical Drug: CORVERT