Suppliers and packagers for LOTENSIN

LOTENSIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851	NDA	Validus Pharmaceuticals LLC	30698-448-01	100 TABLET in 1 BOTTLE (30698-448-01)	1991-06-21
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851	NDA	Validus Pharmaceuticals LLC	30698-449-01	100 TABLET in 1 BOTTLE (30698-449-01)	1991-06-21
Validus Pharms	LOTENSIN	benazepril hydrochloride	TABLET;ORAL	019851	NDA	Validus Pharmaceuticals LLC	30698-450-01	100 TABLET in 1 BOTTLE (30698-450-01)	1991-06-21

Suppliers for the Pharmaceutical Drug: Lotensin

Last updated: October 15, 2025

Introduction

Lotensin is the brand name for benazepril, an angiotensin-converting enzyme (ACE) inhibitor primarily prescribed for managing hypertension and certain types of heart failure. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1991, Lotensin has become a staple in cardiovascular therapy, with a broad global supplier base ranging from large pharmaceutical manufacturers to generic drug producers. Understanding the landscape of suppliers for Lotensin provides valuable insights into its market dynamics, supply chain reliability, and potential procurement considerations for healthcare providers and distributors.

Manufacturers and Key Suppliers

1. Original Brand Manufacturer: Novartis

Novartis, a leading multinational pharmaceutical company headquartered in Switzerland, originally developed and marketed Lotensin. As the patent-holder until its expiration in the United States and many other jurisdictions, Novartis was the exclusive supplier of branded Lotensin formulations. Although patent expiration has paved the way for generic competition, Novartis continues to manufacture and distribute Lotensin in markets where its brand presence persists or where it maintains manufacturing capacity for specific formulations.

2. Generic Manufacturers

Following patent expiry, numerous generic pharmaceutical companies entered the market to produce benazepril. These companies source bulk active pharmaceutical ingredients (APIs) from specialized API producers and comply with regulatory requirements such as the FDA’s Generic Drug User Fee Amendments (GDUFA) to ensure quality standards. Key generic suppliers include:

• Amneal Pharmaceuticals: A major US-based generic drug manufacturer with an extensive portfolio of ACE inhibitors, including benazepril.

• Teva Pharmaceuticals: An Israeli-based giant recognized globally for its broad generics catalog, including benazepril.

• Mylan (now part of Viatris): One of the largest generic companies, supplying benazepril in multiple markets.

• Sun Pharmaceutical Industries: An Indian pharmaceutical leader manufacturing generic benazepril for various regions.

• Aurobindo Pharma: Indian producer with a significant market share in ACE inhibitors.

• Hetero Labs and Dr. Reddy’s Laboratories: Other prominent Indian manufacturers supplying generics for international markets.

These companies typically source APIs from specialized API producers in India, China, and Europe, and then formulate the final drug product according to regulatory standards.

3. API Manufacturers and Supply Chain Dynamics

The API sourcing chain remains crucial in the manufacture of Lotensin generics. Large API producers such as Sandoz, Hikal Ltd., Molecular Weizmann Ltd., and Chinese firms like North China Pharmaceutical Group Corporation are significant API suppliers for benazepril. The API market for ACE inhibitors is highly competitive, with quality control, cost, and regulatory compliance being key factors influencing procurement choices.

4. Regulatory and Market Considerations

Generic manufacturers must obtain approval from regulatory authorities such as the FDA, European Medicines Agency (EMA), or other regional agencies. These approvals are contingent on bioequivalence studies, manufacturing standards (GMP compliance), and quality assurance. Regulatory variations influence supplier selection and market availability, with some manufacturers preferring local or regional API sources to streamline approval processes.

Supply Chain Challenges and Opportunities

While the landscape for Lotensin suppliers is broad, ongoing challenges include:

• API Supply Disruptions: Dependence on Chinese and Indian API producers exposes manufacturers to geopolitical and logistical risks, which can impact drug availability.

• Quality Assurance: Ensuring consistent pharmaceutical and API quality is critical, encouraging partnerships with established suppliers with robust GMP compliance.

• Pricing Pressures: The generic market’s competitive nature pressures prices downward, affecting supplier margins but classifying sourcing among the main differentiators.

• Regulatory Landscape: Changes in regulatory standards or shifts toward more localized manufacturing can influence supplier relationships and market access.

Global Market Presence

The majority of Lotensin’s supply comes from the United States, India, and China. Large pharmaceutical chains in the U.S., including CVS, Walgreens, and authorized generic producers, distribute Lotensin widely. Importantly, some countries have local manufacturing or approved alternative sources, impacting global supply security.

Conclusion

The supply ecosystem for Lotensin, encompassing original manufacturer Novartis and diverse generic producers, reflects the broader dynamics of the ACE inhibitor market. The transition from proprietary to generic formulations has broadened supplier options, but supply chain resilience hinges on quality, regulatory compliance, and logistical stability. For healthcare entities, establishing relationships with reliable, GMP-compliant suppliers ensures consistent access to this vital antihypertensive agent.

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Key Takeaways

• The original patent-holder for Lotensin was Novartis; however, the market is now predominantly supplied by a wide network of generic manufacturers, chiefly in India and China.

• Ensuring API quality and regulatory compliance remains central to maintaining a stable supply chain for Lotensin.

• Supply chain disruptions from geopolitical tensions or logistical challenges can impact drug availability; diversification of suppliers mitigates these risks.

• Regulatory approval processes influence which suppliers can distribute Lotensin in specific regions, shaping market access.

• Pharmaceutical buyers should prioritize suppliers with proven GMP compliance and a track record of stability to ensure uninterrupted supply.

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FAQs

1. Who are the main suppliers of generic benazepril (Lotensin)?
Major generic suppliers include Amneal, Teva, Mylan (Viatris), Sun Pharma, Aurobindo, Hetero, and Dr. Reddy’s. They source APIs from API manufacturers in India and China and comply with regional regulatory standards.

2. How has the expiration of the Lotensin patent affected its supply chain?
Patent expiration opened the market to numerous generic producers, increasing supply options and driving competition, which tends to reduce prices and improve access.

3. What factors influence a pharmaceutical company's choice of supplier for benazepril?
Quality of API, regulatory compliance, cost-effectiveness, supply chain reliability, and the supplier’s manufacturing capacity primarily guide procurement decisions.

4. Are there supply risks associated with the geographic distribution of API manufacturers?
Yes. Reliance on Chinese and Indian API producers exposes manufacturers to geopolitical risks, trade restrictions, and supply chain disruptions, potentially impacting drug availability.

5. How do regulatory standards impact supplier selection?
Suppliers must meet regional regulatory requirements, including GMP certification and bioequivalence approvals, to be authorized to supply Lotensin in specific markets, thus influencing procurement choices.

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Sources

[1] U.S. Food and Drug Administration. "Benazepril: Drug Approval Data." FDA, 1991.
[2] Novartis Product Portfolio. "Lotensin." Novartis AG.
[3] IMS Health Data. Global Pharmaceutical Market Trends.
[4] Indian API Manufacturers' Reports. "API Production & Quality Standards." Indian Pharmaceutical Industry.
[5] European Medicines Agency. "Regulatory Standards for Generics." EMA.