Suppliers and packagers for vasotec

vasotec

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998	NDA	Bausch Health US LLC	0187-0140-30	30 TABLET in 1 BOTTLE (0187-0140-30)	1988-07-26
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998	NDA	Bausch Health US LLC	0187-0140-90	90 TABLET in 1 BOTTLE (0187-0140-90)	1988-07-26
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998	NDA	Bausch Health US LLC	0187-0141-30	30 TABLET in 1 BOTTLE (0187-0141-30)	1985-12-24
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998	NDA	Bausch Health US LLC	0187-0141-90	90 TABLET in 1 BOTTLE (0187-0141-90)	1985-12-24

Suppliers for the Pharmaceutical Drug: Vasotec

Last updated: July 30, 2025

Introduction
Vasotec, the brand name for enalapril, is an angiotensin-converting enzyme (ACE) inhibitor primarily used to treat hypertension and heart failure. As a critical therapeutic agent in cardiovascular medicine, Vasotec’s supply chain involves various pharmaceutical companies and generic manufacturers operating globally. Ensuring consistent availability of Vasotec necessitates a comprehensive understanding of its primary suppliers, manufacturing facilities, and the competitive landscape within the ACE inhibitor market. This analysis offers an in-depth overview of suppliers, manufacturing dynamics, regulatory aspects, and supply chain considerations pertinent to Vasotec.

Manufacturers of Enalapril and Vasotec

1. Original Patent Holder and Early Suppliers
Monarch Pharmaceuticals (now a part of Novartis) originally developed Vasotec in the 1980s. Novartis, through its subsidiary Sandoz, was among the initial key suppliers of enalapril, leveraging innovative synthesis and manufacturing processes. Innovation in formulation delivery—such as oral tablets—secured market penetration. However, patent expiration has facilitated broader manufacturing participation.

2. Generic Manufacturers
With patent expiry, multiple generic pharmaceutical companies now produce enalapril, including Vasotec’s generic equivalents. These companies span the globe, especially in regions like India, China, and Europe, where robust pharmaceutical manufacturing capabilities exist. Key generic suppliers include:

• Dr. Reddy’s Laboratories (India): One of the leading producers of enalapril, offering generic versions adhering to international quality standards.
• Sun Pharmaceutical Industries (India): A major player supplying enalapril globally with a focus on cost-effective manufacturing.
• Hetero Labs (India): Produces generic enalapril with extensive distribution across emerging markets.
• Mylan (now part of Viatris): A significant supplier of enalapril tablets, serving numerous countries with high-volume requirements.
• Teva Pharmaceuticals (Israel): Provides generic enalapril, with distribution channels across North America, Europe, and Asia.

3. Contract Manufacturing Organizations (CMOs)
Some pharmaceutical companies rely on CMOs to produce enalapril for both branded and generic markets. These CMOs include firms like Patheon (by Thermo Fisher Scientific) and Piramal Pharma Solutions, which offer manufacturing scalability and regulatory compliance, ensuring supply continuity.

Supply Chain and Regulatory Considerations

1. Global Manufacturing Footprint
The supply chain for Vasotec hinges on manufacturing facilities compliant with Good Manufacturing Practices (GMP), sanctioned by agencies such as the FDA, EMA, and PMDA. Indian firms dominate the manufacturing landscape due to cost advantages and regulatory compliance capacity, but facilities are subject to periodic inspections to maintain approvals. Disruptions, whether due to regulatory actions, political stability, or pandemic-related issues, can impact supply continuity.

2. Regulatory Approvals and Market Distribution
Generic enalapril products, including Vasotec equivalents, require regulatory approvals in each jurisdiction. The FDA’s ANDA (Abbreviated New Drug Application) pathway simplifies approval for generics that demonstrate bioequivalence. Manufacturers with approved ANDAs for enalapril hold a competitive advantage, influencing supply stability and pricing. Furthermore, regional regulators may have differing requirements, affecting international supply chains.

3. Supply Chain Risks
Key risks include raw material shortages, manufacturing disruptions, quality control issues, and geopolitical factors. Price fluctuations in raw ingredients such as acetic anhydride (used in synthesis) can affect production costs. Logistical challenges also play a role, especially amid global supply chain disruptions like those seen during COVID-19. Diversification of suppliers and strategic inventory management mitigate these risks but require prudent planning.

Market Dynamics and Competitive Landscape

1. Price Competition and MarketShare
Post-patent expiration, large-scale generic manufacturers have driven prices downward, increasing access but squeezing profit margins for original patent-holders and brand-name manufacturers. Multiple suppliers competing on price and quality have enhanced supply security but created a highly commoditized market environment.

2. Regional Variations in Supply
Developed markets predominantly depend on regulated manufacturers with strict quality control. Conversely, emerging markets display a broader variety of suppliers, sometimes with variable regulatory oversight, which can influence supply reliability and product quality. This disparity underscores the importance of due diligence for procurement decisions.

3. Recent Trends and Future Outlook
The trend toward biosimilar and alternative therapies for hypertension may influence long-term demand. Nonetheless, enalapril remains a staple in hypertension management owing to its efficacy and cost-effectiveness. Manufacturers focus on increasing production capacity and enhancing formulation stability to meet global demand, especially in markets with growing hypertension prevalence. Additionally, ongoing regulatory negotiations, patent litigations, and supply chain innovations will shape the future landscape of Vasotec suppliers.

Conclusion

The supply chain for Vasotec involves a diverse array of manufacturers, predominantly generic pharmaceutical companies located in India, China, and other emerging markets. Established companies like Dr. Reddy’s, Sun Pharma, and Viatris supply high-volume markets, leveraging GMP-compliant manufacturing facilities and approved regulatory pathways. The proliferation of generic options has resulted in a competitive environment characterized by price pressure and supply chain diversification. Regulatory oversight, raw material availability, geopolitical stability, and operational resilience remain crucial factors influencing supply continuity. Strategic sourcing, ongoing quality assurance, and diversified manufacturing partnerships are vital for stakeholders seeking reliable Vasotec supply.

Key Takeaways

• Major suppliers include Indian pharmaceutical giants such as Dr. Reddy’s, Sun Pharma, and Viatris, with manufacturing facilities spanning Asia and Europe.
• Patent expiration has democratized Vasotec production, resulting in a broad supplier base and greater price competition.
• Supply chain risks involve raw material shortages, manufacturing disruptions, and regulatory challenges, necessitating active risk management.
• Regulatory approvals via FDA’s ANDA pathway underpin the market entry and ongoing supply of generic enalapril products.
• Future supply stability depends on manufacturing capacity expansion, geopolitical stability, and continued adherence to GMP standards.

FAQs

1. Are there differences in quality between branded Vasotec and generic enalapril?
   Quality standards are regulated internationally; generic enalapril produced by WHO-GMP compliant manufacturers are bioequivalent and meet the same safety and efficacy requirements as the branded version.

2. Which countries are the primary sources of Vasotec supply?
   India is the leading source due to its robust pharmaceutical manufacturing sector. Other key suppliers include China, Israel, and European nations.

3. Has the supply of Vasotec been disrupted recently?
   While rare, disruptions can occur due to raw material shortages, regulatory inspections, or supply chain interruptions, especially during global crises like the COVID-19 pandemic.

4. How do regulatory changes impact Vasotec suppliers?
   Regulatory updates can delay approvals, necessitate manufacturing adjustments, or restrict supply if compliance is not maintained, emphasizing the importance of continuous regulatory vigilance.

5. What are the prospects for new manufacturers entering the Vasotec supply chain?
   Entry is feasible through regulatory approval pathways such as the FDA’s ANDA process, although establishing GMP-compliant manufacturing and obtaining necessary approvals require substantial investment and time.

References

[1] U.S. Food and Drug Administration. ANDA approvals for enalapril.
[2] Novartis. History of Vasotec.
[3] Indian Pharmaceutical Industry Reports. Market overview and key players.
[4] World Health Organization. GMP Guidelines and global manufacturing standards.
[5] Market analyses on generic ACE inhibitors and supply chain trends.