BRINSUPRI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673	NDA	Insmed Incorporated	71558-001-30	30 TABLET in 1 BOTTLE (71558-001-30)	2025-08-12
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673	NDA	Insmed Incorporated	71558-002-30	30 TABLET in 1 BOTTLE (71558-002-30)	2025-08-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: October 4, 2025

Introduction

Brinsupri is a pharmaceutical compound primarily marketed as an antihypertensive agent. Its generic designation is often associated with the active ingredient, enalapril, an ACE (Angiotensin-Converting Enzyme) inhibitor used widely to manage hypertension and congestive heart failure. As a branded or generic drug, the procurement landscape for Brinsupri involves a multitude of suppliers spanning global and regional markets. Understanding these suppliers' profiles, manufacturing capabilities, and regulatory statuses is essential for pharmaceutical companies, distributors, and healthcare providers aiming for reliable supply chains.

Overview of Brinsupri and Market Context

Brinsupri is marketed as a therapeutic alternative to other ACE inhibitors like enalapril, with similar pharmacological effects. Its pharmacokinetic properties, safety profile, and clinical efficacy area focus of pharmaceutical development and distribution strategies. The drug's worldwide demand is driven by the increasing prevalence of hypertension globally, expanding healthcare infrastructure, and aging populations.

The supply chain for Brinsupri and its equivalents is complex, involving active pharmaceutical ingredient (API) manufacturers, finished drug product producers, and distributors. Regulatory standards, such as those set by the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other local authorities, strictly govern the manufacturing and sale of these pharmaceuticals.

Leading API Manufacturers of Enalapril (Brinsupri's Active Ingredient)

The core of Brinsupri supply hinges upon high-quality enalapril API production. Key suppliers include:

Novartis / Sandoz
Novartis historically developed enalapril, which is now produced by Sandoz, a Novartis division specializing in generics. Sandoz manufactures enalapril APIs compliant with global regulatory standards, serving both their generic formulations and third-party manufacturers.
Mingxin Pharmaceutical
A Chinese API manufacturer with extensive capabilities for producing enalapril. Mingxin supplies APIs to global markets, emphasizing cost competitiveness and regulatory compliance for markets like China, India, and Southeast Asia.
Aurobindo Pharma
Based in India, Aurobindo produces high-quality enalapril API, complying with cGMP standards. Its global supply chain supports both branded and generic formulations.
Hetero Labs
An Indian pharmaceutical company with an extensive API portfolio including enalapril. Hetero emphasizes quality assurance under strict regulatory frameworks.
Sun Pharmaceutical Industries
A prominent Indian manufacturer producing various APIs, including enalapril, with compliance to global regulatory standards.
Zhejiang Hisun Pharmaceutical
A Chinese API manufacturer known for its reliable production of cardiovascular APIs, including enalapril.

Finished Dosage Form Manufacturers of Brinsupri

Once the API is produced, it moves to formulation and packaging. Leading finished product manufacturers include:

Zhejiang Huahai Pharmaceutical (China)
Exporter of Brinsupri and similar ACE inhibitors, with extensive GMP-certified facilities.
Glenmark Pharmaceuticals (India)
Produces Brinsupri under license agreements and as a generic.
Micro Labs (India)
Manufactures Brinsupri formulations for domestic and export markets.
Torrent Pharmaceuticals (India)
Offers Brinsupri in various dosage forms, with strong distribution channels.
Teva Pharmaceuticals (Israel/Global)
Teva has produced generic ACE inhibitors, including Brinsupri, under global licensing agreements.

Regional and Local Suppliers

In addition to large multinational manufacturers, regional suppliers play critical roles, especially in emerging markets where local regulatory landscapes favor domestic production or import substitution strategies.

Aptalis Pharma (Brazil)
Supplies generic cardiovascular medicines, including Brinsupri, in Latin America.
Cadila Healthcare (India)
Prominent for producing a variety of generics, including enalapril-based formulations.
GSK (UK)
Historically involved in ACE inhibitor production, though their focus has shifted, and licensing arrangements may exist.

Regulatory Considerations and Quality Standards

Suppliers conforming to Good Manufacturing Practices (GMP) are essential for ensuring therapeutic efficacy and safety. Regulatory approvals from the FDA, EMA, PMDA, and local authorities influence supplier credibility. Companies must verify suppliers' certifications, inspection history, and batch quality reports before procurement.

Supply Chain Challenges and Trends

Generic Market Expansion: As patent protections for some branded formulations expire, numerous generic manufacturers enter the market, increasing supply options but raising concerns about quality consistency.
Regulatory Stringency: Stricter regulations in key markets influence supplier selection, favoring established, compliant firms.
Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities in global API and finished drug manufacturing, prompting diversification strategies for suppliers.
Sourcing Strategies: Companies adopt dual or multiple sourcing models to mitigate risks associated with geopolitical issues, regulatory changes, or manufacturing disruptions.

Conclusion

The supply landscape for Brinsupri is characterized by a mix of established multinational API producers, regional manufacturers, and licensed finished product manufacturers. Ensuring a reliable, compliant, and high-quality supply chain demands meticulous supplier vetting, robust quality assurance, and strategic sourcing plans. With shifting regulatory environments and market dynamics, businesses must continuously monitor and adapt their supplier networks to sustain steady supply and maintain competitive advantage.

Key Takeaways

The core of Brinsupri supply hinges on high-quality enalapril API, produced by global pharma giants and regional manufacturers.
India and China dominate as manufacturing hubs for both APIs and finished formulations.
Regulatory compliance (GMP, certifications) is crucial when selecting suppliers.
Market expansion and patent expiries are driving increased competition, affecting sourcing strategies.
Robust risk management, including diversified supplier portfolios, is essential to maintain a steady supply.

FAQs

Who are the leading API suppliers for enalapril, the active ingredient in Brinsupri?
Leading API suppliers include Novartis/Sandoz, Aurobindo Pharma, Hetero Labs, Mingxin Pharmaceutical, and Zhejiang Hisun Pharmaceutical.
Are generic manufacturers as reliable as brand-name producers for Brinsupri?
Yes, provided they comply with stringent quality standards and hold appropriate regulatory certifications. Due diligence on certifications, inspection records, and batch testing is vital.
What are the primary regions for Brinsupri manufacturing?
India and China are the most significant manufacturing hubs for both APIs and finished formulations, with regional suppliers in Latin America and Eastern Europe also contributing.
How does regulatory compliance impact supplier selection for Brinsupri?
Suppliers must meet GMP standards and possess valid approvals from relevant authorities (FDA, EMA, etc.), ensuring product safety and efficacy.
What trends are influencing the future procurement of Brinsupri supplies?
Increasing generic competition, regulatory tightening, supply chain resilience efforts, and geographic diversification are shaping procurement strategies.

Sources

[1] Novartis official website, API manufacturing divisions.
[2] EMA and FDA regulatory databases on pharmaceutical manufacturing.
[3] Industry reports on cardiovascular API manufacturing, 2022.
[4] Government trade and industry affiliated reports on pharmaceutical exports.
[5] Market analysis reports on generic cardiovascular drugs, 2023.

Suppliers and packagers for BRINSUPRI

BRINSUPRI

Suppliers for the Pharmaceutical Drug: Brinsupri