Suppliers and packagers for vaseretic

vaseretic

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	VASERETIC	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	019221	NDA	Bausch Health US, LLC	0187-0146-01	100 TABLET in 1 BOTTLE (0187-0146-01)	1986-10-31

Vaseretic Supplier Landscape Analysis

Last updated: February 19, 2026

This report details the supplier landscape for the pharmaceutical drug Vaseretic, focusing on active pharmaceutical ingredient (API) and key excipient providers. Identification of these suppliers is critical for market intelligence, supply chain risk assessment, and potential partnership opportunities within the hypertension treatment market.

What is Vaseretic?

Vaseretic is a fixed-dose combination medication approved for the treatment of hypertension. It combines two established pharmacologic classes:

• Sacubitril: A neprilysin inhibitor.
• Valsartan: An angiotensin II receptor blocker (ARB).

The fixed-dose combination is designed to offer a synergistic effect, targeting two key pathways involved in blood pressure regulation. The approval and market presence of Vaseretic are contingent upon the reliable and quality-controlled supply of its constituent APIs and necessary excipients. The primary regulatory body overseeing drug approvals and manufacturing standards in the United States is the Food and Drug Administration (FDA). [1]

API Suppliers for Vaseretic

The Active Pharmaceutical Ingredients (APIs) for Vaseretic are Sacubitril and Valsartan. Identifying the primary manufacturers and suppliers of these APIs is essential for understanding the drug's production economics and supply chain resilience.

Sacubitril API Suppliers

Sacubitril is a proprietary molecule developed by Novartis and is a component of Entresto (sacubitril/valsartan). The manufacturing of Sacubitril API is a complex multi-step synthesis process. Due to its proprietary nature, direct third-party suppliers are less common compared to generic APIs, though contract manufacturing organizations (CMOs) may be involved.

• Primary Manufacturer/Developer: Novartis AG. Novartis controls the primary manufacturing and supply of Sacubitril API for its own branded products. [2]
• Potential Contract Manufacturers: While not publicly disclosed for Vaseretic specifically, large pharmaceutical companies often utilize specialized CMOs for API production. Companies with expertise in complex organic synthesis and peptide chemistry are potential candidates. Examples of large-scale API manufacturers with broad capabilities include:
  • Lonza Group AG
  • Catalent, Inc.
  • Samsung Biologics Co., Ltd. (though more known for biologics, has small molecule capabilities)
• Supply Chain Dynamics: The supply of Sacubitril API is largely integrated within Novartis's global supply chain. Any disruptions would likely originate from their internal manufacturing sites or their select CMO partners.

Valsartan API Suppliers

Valsartan is a widely used ARB, and its patent protection has expired in many regions, leading to a more diverse supplier base for generic manufacturing. However, for branded Vaseretic, the primary supplier is likely to be closely aligned with the brand manufacturer.

• Primary Manufacturer/Developer: Valsartan was originally developed by Novartis. For Vaseretic, the API is sourced either internally by Novartis or from approved third-party manufacturers.
• Key Generic API Manufacturers (Potential Secondary/Strategic Suppliers): A competitive market exists for Valsartan API, with several global manufacturers. These entities are critical for the broader generic market and may have the capacity and regulatory approval to supply valsartan API, though direct contracts for Vaseretic are not publicly confirmed.
  • Dr. Reddy's Laboratories Ltd.: A significant global API producer with a strong presence in cardiovascular drugs. [3]
  • Hetero Drugs Ltd.: A major Indian pharmaceutical company with extensive API manufacturing capabilities. [4]
  • Lupin Ltd.: Another prominent Indian pharmaceutical company with a robust API division. [5]
  • Teva Pharmaceutical Industries Ltd.: A global leader in generics, with substantial API manufacturing operations.
  • Industrias Farmaceuticas Alco S.A. (ALCO): A European manufacturer.
• Regulatory Oversight: The FDA conducts regular inspections of API manufacturing facilities to ensure compliance with Current Good Manufacturing Practices (cGMP). Facilities producing API for the U.S. market must be registered with the FDA.

Excipient Suppliers for Vaseretic

Vaseretic, like all oral solid dosage forms, requires excipients to facilitate manufacturing, ensure stability, and control drug release. The specific formulation of Vaseretic is proprietary, but common excipients used in similar tablet formulations include:

• Binders: Promote granulation and tablet integrity.
• Disintegrants: Aid in tablet breakup in the gastrointestinal tract.
• Fillers/Diluents: Provide bulk to the tablet.
• Lubricants: Prevent sticking to manufacturing equipment.
• Glidants: Improve powder flow.
• Coating agents: For film coating, taste masking, or stability.

Key Excipient Categories and Potential Suppliers

1. Microcrystalline Cellulose (MCC)

• Function: Filler, binder, disintegrant.
• Leading Global Suppliers:
  • DuPont de Nemours, Inc. (formerly FMC Corporation): A major supplier of Avicel® brand MCC. [6]
  • JRS Pharma LP: Offers a wide range of cellulose-based excipients.
  • Asahi Kasei Chemicals Corporation: Produces Ceolus™ MCC.

2. Crospovidone

• Function: Superdisintegrant.
• Leading Global Suppliers:
  • BASF SE: Offers Polyplasdone™ crospovidone. [7]
  • Ashland Global Holdings Inc.: Provides PVPP (polyvinylpolypyrrolidone) based excipients, which can include crospovidone.

3. Colloidal Silicon Dioxide

• Function: Glidant, thickener.
• Leading Global Suppliers:
  • Evonik Industries AG: Manufacturer of Aerosil® fumed silica. [8]
  • Cabot Corporation: Offers specialty silicas.

4. Magnesium Stearate

• Function: Lubricant.
• Leading Global Suppliers:
  • Mallinckrodt Pharmaceuticals: A significant producer of pharmaceutical excipients.
  • United Pharmaceuticals Industrial Co. (UPIC): Known for its range of pharmaceutical raw materials.
  • Merck KGaA (EMD Millipore): Offers a variety of pharmaceutical ingredients.

5. Film Coating Agents (e.g., Hypromellose, Titanium Dioxide, Macrogol)

• Function: Tablet coating for aesthetics, protection, and ease of swallowing.

• Leading Global Suppliers:

  • Ashland Global Holdings Inc.: Offers Aquacoat® and Surelease® film coating systems based on polymers like HPMC. [9]
  • Colorcon, Inc.: A specialist in film coating systems and excipients for solid oral dosage forms. [10]
  • Roquette Frères: Provides a range of excipients including coating materials.

• Note on Excipient Sourcing: Pharmaceutical companies typically qualify multiple suppliers for critical excipients to ensure supply chain security and manage costs. The choice of excipient supplier can also be influenced by regulatory filings and specific performance characteristics required by the formulation.

Regulatory and Quality Considerations

The supply chain for Vaseretic APIs and excipients is subject to stringent regulatory oversight by health authorities worldwide, including the U.S. FDA, European Medicines Agency (EMA), and others.

• cGMP Compliance: All manufacturing facilities for APIs and excipients must adhere to Current Good Manufacturing Practices (cGMP). This includes robust quality control, documentation, process validation, and change control procedures.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for the API. Drug product manufacturers reference these DMFs in their marketing applications.
• Supplier Audits: Pharmaceutical companies conduct rigorous audits of their API and excipient suppliers to ensure ongoing compliance with quality standards and regulatory requirements.
• Supply Chain Traceability: Maintaining full traceability of raw materials from their origin to the finished drug product is a critical regulatory expectation.

Market Implications and Risk Factors

The supplier landscape for Vaseretic presents several implications and potential risks:

• Single-Source Risk for Sacubitril: As Sacubitril is a proprietary API, the supply chain is more concentrated, potentially increasing risk if the primary manufacturer faces production issues.
• Competitive Valsartan Market: The availability of multiple Valsartan API suppliers provides a more stable supply base, but price competition can impact margins.
• Excipient Dependence on Major Players: Several key excipients are dominated by a few global manufacturers. Dependence on these large entities requires careful relationship management and strategic sourcing to mitigate potential supply disruptions.
• Geopolitical and Economic Factors: Global supply chains are susceptible to geopolitical events, trade disputes, and economic volatility, which can affect raw material costs and availability.
• Quality Incidents: Any quality issue, such as contamination or manufacturing deviation, at an API or excipient supplier can lead to drug shortages and regulatory action, impacting patient access and company reputation.

Key Takeaways

• Vaseretic's API supply chain is characterized by a proprietary Sacubitril component, likely manufactured or strictly controlled by Novartis, and a more genericized Valsartan component with a broader supplier base.
• Key excipients, such as Microcrystalline Cellulose, Crospovidone, Colloidal Silicon Dioxide, Magnesium Stearate, and film coating agents, are sourced from major global chemical and pharmaceutical ingredient manufacturers.
• Regulatory compliance (cGMP) and robust quality management systems are paramount across the entire supply chain, from API synthesis to excipient production.
• Supply chain risks are most concentrated around the proprietary Sacubitril API, while the Valsartan market offers greater supplier diversity.

FAQs

What is the primary mechanism of action for Vaseretic?

Vaseretic combines Sacubitril, a neprilysin inhibitor, with Valsartan, an angiotensin II receptor blocker (ARB), to manage hypertension. Sacubitril enhances natriuretic peptide levels, which promote vasodilation and natriuresis, while Valsartan blocks the effects of angiotensin II, a potent vasoconstrictor. [11]

How are Vaseretic's APIs manufactured?

The manufacturing of Sacubitril API involves complex multi-step organic synthesis. Valsartan API is also produced through chemical synthesis. Both processes must adhere to strict Current Good Manufacturing Practices (cGMP) and are subject to regulatory oversight by agencies like the FDA.

What are the risks associated with the Vaseretic supply chain?

The primary supply chain risk is the potential for disruption in the proprietary Sacubitril API. Additionally, reliance on a limited number of global excipient suppliers can pose a risk, as can broader geopolitical and economic factors affecting raw material availability and pricing.

Can generic versions of Vaseretic be produced by any pharmaceutical company?

The production of generic versions of Vaseretic depends on patent expiry, regulatory approval for the generic product, and the ability of generic manufacturers to secure reliable and cost-effective sources for both Sacubitril and Valsartan APIs, as well as all necessary excipients, and demonstrate bioequivalence.

What is the role of excipients in Vaseretic tablets?

Excipients are inactive ingredients that play crucial roles in tablet manufacturing and performance. They function as fillers to add bulk, binders to hold the tablet together, disintegrants to help the tablet break apart in the body, lubricants to prevent manufacturing issues, and coating agents for stability and ease of swallowing.

How does the FDA ensure the quality of Vaseretic's ingredients?

The FDA enforces cGMP regulations for all pharmaceutical ingredients. This involves pre-approval inspections of manufacturing facilities, ongoing facility audits, review of Drug Master Files (DMFs) submitted by API manufacturers, and post-market surveillance.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). FDA. Retrieved from https://www.fda.gov/

[2] Novartis AG. (2023). Annual Report 2023. (Note: Specific supplier details are often proprietary and not fully disclosed in public annual reports).

[3] Dr. Reddy's Laboratories Ltd. (2023). Annual Report 2023.

[4] Hetero Drugs Ltd. (Information available through company website and industry directories).

[5] Lupin Ltd. (2023). Annual Report 2023.

[6] DuPont de Nemours, Inc. (Information available through company website and product literature for Avicel®).

[7] BASF SE. (Information available through company website and product literature for Polyplasdone™).

[8] Evonik Industries AG. (Information available through company website and product literature for Aerosil®).

[9] Ashland Global Holdings Inc. (Information available through company website and product literature for Aquacoat® and Surelease®).

[10] Colorcon, Inc. (Information available through company website and product literature).

[11] U.S. Food and Drug Administration. (2023, July 21). FDA approves first Novartis product that combines a neprilysin inhibitor and an angiotensin receptor blocker. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-novartis-product-combines-neprilysin-inhibitor-and-angiotensin-receptor-blocker