Suppliers and packagers for accupril

accupril

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885	NDA	Parke-Davis Div of Pfizer Inc	0071-0527-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-0527-23)	1991-11-19
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885	NDA	Parke-Davis Div of Pfizer Inc	0071-0530-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-0530-23)	1991-11-19
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885	NDA	Parke-Davis Div of Pfizer Inc	0071-0532-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-0532-23)	1991-11-19
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885	NDA	Parke-Davis Div of Pfizer Inc	0071-0535-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-0535-23)	1991-11-19

Suppliers for the Pharmaceutical Drug: ACCUPRIL

Last updated: August 4, 2025

Introduction

Accupril, also known by its generic name quinapril, is an angiotensin-converting enzyme (ACE) inhibitor primarily prescribed to manage hypertension and congestive heart failure. Its efficacy hinges on the quality and reliability of its supply chain. As a vital medication within cardiovascular treatment protocols, understanding the landscape of suppliers for Accupril is crucial for healthcare providers, pharmaceutical distributors, and strategic partners aiming to ensure uninterrupted patient access.

Manufacturers and Original Equipment Manufacturers (OEMs)

The origin of Accupril’s supply typically traces back to original manufacturers, who develop, produce, and distribute the drug under brand licensing agreements or patent protections. Pfizer Inc., the patent holder and original innovator for Accupril (marketed since 1980), remains the primary global supplier. The company's manufacturing facilities in the United States and other regions adhere to rigorous Good Manufacturing Practices (GMP), ensuring quality and regulatory compliance.

However, once patent protections expire, the market opens to generic manufacturers. The expiration of Accupril’s patent rights in numerous jurisdictions catalyzes increased competition, leading to a diversified supplier landscape for generic quinapril.

Generic Manufacturers

Following patent expiration, multiple pharmaceutical companies have entered the quinapril supply chain. These manufacturers produce bioequivalent formulations that meet regulatory standards set by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulators.

Key global generic producers include:

• Teva Pharmaceuticals: One of the largest generic drug producers globally, Teva manufactures quinapril across various markets, leveraging extensive production facilities across Israel, India, and Europe.
• Mylan (now part of Viatris): A substantial player in the generic ACE inhibitors arena, Mylan supplies quinapril capsules and tablets for multiple markets, following stringent quality standards.
• Sun Pharmaceutical Industries: An Indian multinational pharmaceutical company with significant share in the ACE inhibitor market, offering quinapril formulations compliant with international standards.
• Hetero Drugs: Indian generics manufacturer producing quinapril for both domestic and export markets.
• Aurobindo Pharma: Another Indian pharmaceutical giant with a diversified portfolio, including quinapril, meeting global regulatory requirements.

Regional and domestic manufacturers also supply quinapril, especially within emerging markets where local generics are prevalent, expanding the global supplier base.

Supply Chain Dynamics and Factors Influencing Suppliers

The supply chain for Accupril is characterized by several key factors:

• Regulatory Compliance: Suppliers must adhere to GMP standards and obtain approval from regulatory agencies in target markets. This requirement acts as a barrier to entry but assures quality.
• Manufacturing Capacity and Scalability: Providers with extensive manufacturing capabilities are better positioned to meet global demand surges, particularly during health crises or supply disruptions.
• Price Competition: As patent barriers diminish, price becomes a critical determinant. Generics often compete aggressively on cost, influencing supplier choices for healthcare providers and distributors.
• Supply Chain Resilience: Geographic diversification of manufacturing facilities mitigates risks posed by geopolitical issues, natural disasters, or pandemics.

Distribution Channels and Logistics

Once manufactured, Accupril reaches end-users via multiple distribution channels:

• Pharmaceutical Wholesalers and Distributors: Major distributors such as McKesson, Cardinal Health, and Alliance Healthcare serve as intermediaries, stocking and supplying Accupril to pharmacies and hospitals.
• Direct Supply to Healthcare Facilities: Some manufacturers maintain direct contracts with hospitals and clinics, especially in bulk procurement scenarios.
• Regulatory and Certification Considerations: Packaging, labeling, and shipment must comply with country-specific regulations, impacting logistics vendors and supply chains.

Market Share and Geographical Distribution

The global market for quinapril is concentrated primarily in North America, Europe, and parts of Asia-Pacific. Pfizer historically dominated the market but now shares it with several generic manufacturers aided by increasing regulatory approvals for generics. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approve multiple suppliers annually, thereby broadening options for procurement.

Challenges and Risks in the Supply Chain

Supply chain stability is vulnerable to:

• Manufacturing Disruptions: Quality compliance failures or facility shutdowns can cause shortages.
• Regulatory Delays: Delays in approval or re-approval processes impact market availability.
• Market Competition: Price wars among generics can lead to supply consolidation, influencing availability and pricing.
• Patent and Patent-expiry-Related Litigation: Legal battles may restrict the entry of specific suppliers temporarily.

Key Takeaways

• Pfizer remains the primary original manufacturer of Accupril, with a diversified base of generic manufacturers since patent expiry.
• Indian companies like Sun Pharmaceutical, Aurobindo, and Hetero are significant players in the generic quinapril landscape, supported by robust manufacturing standards.
• Supply chain resilience depends on geographic diversification, regulatory adherence, and capacity scalability.
• Distribution channels include major global wholesalers and direct contracts with healthcare institutions, ensuring broad market reach.
• Continuous regulatory oversight and quality assurance are essential to maintaining supply stability in this competitive landscape.

Frequently Asked Questions (FAQs)

1. Who are the leading suppliers of generic quinapril (Accupril)?
Major generic quinapril producers include Teva Pharmaceuticals, Mylan (Viatris), Sun Pharmaceutical Industries, Hetero Drugs, and Aurobindo Pharma, primarily based in India and other regions with robust pharmaceutical manufacturing sectors.

2. How does patent expiry affect the supply chain of Accupril?
Patent expiry opens the market to numerous generic manufacturers, increasing supply options, intensifying price competition, and expanding regional availability—though it may also introduce supply variability until production capacities stabilize.

3. Are there regional differences in Accupril suppliers?
Yes. While the U.S. and Europe predominantly rely on global brands like Pfizer and approved generics, emerging markets often see local manufacturers, especially Indian and Chinese companies, supplying quinapril at lower costs.

4. What regulatory standards must suppliers for Accupril meet?
Suppliers must adhere to GMP standards from agencies like the FDA and EMA, meet quality control benchmarks, and secure necessary approvals for each market segment, ensuring safety and efficacy.

5. What factors should healthcare providers consider when sourcing Accupril?
Providers should evaluate supplier reliability, regulatory compliance, cost, delivery timelines, and quality certifications to ensure uninterrupted, safe medication supply.

References

1. U.S. Food and Drug Administration. Approved Drug Products: Quinapril (Accupril). [FDA Website].
2. IQVIA. Global Pharmaceutical Market Analysis 2022.
3. Pfizer Inc. Annual Report 2022.
4. Sun Pharmaceutical Industries Annual Report 2022.
5. European Medicines Agency. List of Approved Generic ACE Inhibitors.

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In conclusion, the supplier landscape for Accupril features a blend of original innovators and a broad spectrum of generic manufacturers, primarily based in India and other emerging markets. For stakeholders, maintaining supply chain resilience, ensuring regulatory compliance, and evaluating cost-performance metrics are essential for consistent access to this vital cardiovascular medication.