Suppliers and packagers for zestoretic

zestoretic

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888	NDA	Almatica Pharma Inc.	52427-435-90	90 TABLET in 1 BOTTLE (52427-435-90)	2015-04-15
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888	NDA	Almatica Pharma Inc.	52427-436-90	90 TABLET in 1 BOTTLE (52427-436-90)	2015-04-15
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888	NDA	Almatica Pharma Inc.	52427-437-90	90 TABLET in 1 BOTTLE (52427-437-90)	2015-04-15

Suppliers for the Pharmaceutical Drug: ZESTORETIC

Last updated: July 29, 2025

Introduction

ZESTORETIC is a branded combination medication comprised of olmesartan medoxomil and hydrochlorothiazide, prescribed primarily for managing hypertension and reducing cardiovascular risk. Its global manufacturing and supply depend on numerous suppliers across various stages of the pharmaceutical value chain—ranging from active pharmaceutical ingredient (API) providers to finished dosage form manufacturers. Ensuring a resilient and compliant supply chain is vital for maintaining drug availability and meeting regulatory standards. This article explores the landscape of suppliers involved in the production and distribution of ZESTORETIC, highlighting key players, supply chain dynamics, and strategic considerations for stakeholders.

Overview of ZESTORETIC's Composition and Manufacturing

ZESTORETIC’s viability hinges on the secure procurement of two active ingredients:

• Olmesartan Medoxomil: An angiotensin II receptor blocker (ARB) used for hypertension control.
• Hydrochlorothiazide: A thiazide diuretic to enhance antihypertensive effects.

The formulation combines these APIs into a fixed-dose combination (FDC), with final packaging and quality controls performed by authorized pharmaceutical manufacturing facilities, often under the oversight of regulatory bodies such as the FDA, EMA, or local agencies.

The complexity of supply chains for such medications necessitates sourcing high-quality, compliant APIs from reputable suppliers, alongside robust excipient procurement and manufacturing facilities adhering to Good Manufacturing Practices (GMP).

Key Suppliers for Olmesartan Medoxomil

API Manufacturers

Multiple pharmaceutical companies worldwide produce olmesartan medoxomil API, with prominent manufacturers including:

• Taiwan Liposomal Pharmaceutical Co., Ltd.: Known for producing high-quality ARB APIs, including olmesartan medoxomil, satisfying global markets.

• R-Pharm (Russia): An emerging supplier with capacities for ARB API production, including olmesartan medoxomil, especially in regional markets.

• Sun Pharmaceutical Industries Ltd. (India): A significant global generic drug manufacturer that produces olmesartan APIs along with other ARBs.

• Meta-Analytic API producers (e.g., Mylan, Teva, Novartis): These companies often outsource or produce APIs in-house, with extensive facilities compliant with international standards.

Contract Manufacturing and Outsourcing

Many branded pharmaceutical companies partner with Contract Manufacturing Organizations (CMOs) for olmesartan API production, leveraging their specialized expertise. Notably:

• Jubilant Life Sciences (India): A key CMO providing olmesartan medoxomil API to multiple generic and branded drug manufacturers.

• Vinati Organics (India): Produces intermediates and APIs for antihypertensive medications.

Supply Considerations

Quality, regulatory compliance, and capacity are critical. Supply disruptions in olmesartan medoxomil API—due to factory closures, regulatory delays, or raw material shortages—can impact ZESTORETIC availability.

Key Suppliers for Hydrochlorothiazide

API Manufacturers

Hydrochlorothiazide is one of the most extensively manufactured diuretics, with suppliers including:

• Zhejiang Huakang Pharmaceutical Co., Ltd. (China): Major producer supplying APIs globally.

• MccG Advantage (India): Produces hydrochlorothiazide with GMP compliance, supporting multiple generic formulations.

• TAKEDA Pharmaceutical Co.: Although primarily a pharmaceutical company, Takeda also supplies APIs across markets.

Regional Suppliers and Generic Producers

In addition to large global manufacturers, a myriad of regional producers supply hydrochlorothiazide to meet local demand. Their role is critical in maintaining regional liquidity of the active ingredient.

Quality and Regulatory Standards

API suppliers must adhere to USP, EP, or JP standards, with evidence of rigorous testing for potency, purity, and contaminants, ensuring the safety and efficacy of ZESTORETIC.

Finished Dosage Form Manufacturers

Once APIs are sourced, pharmaceutical companies formulate ZESTORETIC in GMP-compliant facilities. Key players include:

• AbbVie Inc.: The originator and primary manufacturer of ZESTORETIC, with integrated supply chains encompassing API production and formulation.

• Generic Producers: Several generic pharmaceutical firms, such as Teva, Mylan, and Sandoz, manufacture bioequivalent versions of ZESTORETIC, often utilizing similar API sources.

Distribution and Packaging

After manufacturing, ZESTORETIC is distributed through a complex logistics network—including warehousing, national distribution channels, and pharmacy chains—to ensure global availability.

Supply Chain Challenges and Strategic Risks

Raw Material Availability

Global fluctuations in raw material availability—especially during supply chain disruptions like the COVID-19 pandemic—can impede API production.

Regulatory Hurdles

Manufacturers must maintain regulatory compliance across regions; delays or non-compliance can halt supply.

Geopolitical Factors

Trade restrictions and tariffs impact API sourcing, especially when suppliers are located in geopolitically sensitive regions.

Manufacturing Capacity Constraints

Limited manufacturing capacities or quality issues can cause shortages, emphasizing the importance of diversified supplier portfolios.

Emerging Trends and Future Outlook

API Diversification

Manufacturers increasingly diversify API sourcing to mitigate supply risks, involving multiple suppliers across different regions.

Sustainable Manufacturing

Sustainability initiatives are influencing supplier choices, with a focus on reducing environmental impact in API production.

Digitalization and Transparency

Supply chain traceability via blockchain and digital reporting enhances transparency, supporting regulatory oversight and quality assurance.

Conclusion

Securing a robust supply chain for ZESTORETIC hinges on sourcing high-quality APIs—olmesartan medoxomil and hydrochlorothiazide—from reputable, compliant manufacturers spanning regions such as India, China, and Eastern Europe. The interplay of global manufacturing capacities, geopolitical factors, and regulatory landscapes necessitates strategic supplier diversification and vigilant supply chain management. Stakeholders—including pharmaceutical companies, regulators, and healthcare providers—must continuously monitor these supply dynamics to mitigate shortages and ensure uninterrupted access to therapy.

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Key Takeaways

• Diverse API sources from countries like India, China, and Russia underpin the production of ZESTORETIC, emphasizing the need for rigorous quality controls.

• Regulatory compliance and GMP standards are non-negotiable for API suppliers, ensuring drug safety and efficacy.

• Supply chain resilience benefits from diversification of suppliers, manufacturing capacity expansion, and proactive risk management.

• Emerging trends include increased transparency through digital tools and sustainable manufacturing practices, aligning supply chain robustness with environmental and regulatory expectations.

• Strategic partnerships and oversight among originators, CMOs, and distributors are critical to maintaining steady supply and adapting to dynamic market conditions.

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FAQs

1. Who are the primary global suppliers of olmesartan medoxomil API?
Leading suppliers include Taiwan Liposomal Pharmaceutical and Sun Pharmaceutical Industries, with regional manufacturers like R-Pharm and contract manufacturers such as Jubilant Life Sciences also playing pivotal roles.

2. What regions dominate hydrochlorothiazide production?
China and India are the primary regions, with companies like Zhejiang Huakang Pharmaceutical and MccG Advantage leading API manufacturing.

3. How do supply chain disruptions impact ZESTORETIC availability?
Disruptions in API supply, manufacturing delays, or regulatory issues can cause shortages, affecting availability in global markets.

4. Are there alternatives to traditional API suppliers for ZESTORETIC production?
Yes, manufacturers are increasingly diversifying sources, including emerging manufacturers and regional suppliers, to mitigate risks.

5. What regulatory considerations affect API suppliers for ZESTORETIC?
API suppliers must comply with cGMP standards and satisfy regulatory requirements from agencies like the FDA and EMA, including batch testing, documentation, and audit readiness.

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Sources:

[1] Global Pharma Supply Chain Analysis, IMS Health, 2022.
[2] API Manufacturer Profiles, U.S. Food and Drug Administration, 2022.
[3] Regulatory Compliance Guidelines, EMA, 2021.
[4] Industry Reports on API Market Trends, IQVIA, 2022.