Suppliers and packagers for LOPRESSOR HCT

LOPRESSOR HCT

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	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303	NDA	Validus Pharmaceuticals LLC	30698-461-01	100 TABLET in 1 BOTTLE (30698-461-01)	2014-06-30
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303	NDA	Validus Pharmaceuticals LLC	30698-462-01	100 TABLET in 1 BOTTLE (30698-462-01)	2014-06-30
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303	NDA	Validus Pharmaceuticals LLC	30698-463-01	100 TABLET in 1 BOTTLE (30698-463-01)	2014-06-30

Suppliers for the Pharmaceutical Drug: LOPRESSOR HCT

Last updated: July 28, 2025

Introduction

LOPRESSOR HCT, a combination medication comprising propranolol and hydrochlorothiazide, is used primarily to manage hypertension and certain cardiac conditions. As a widely prescribed drug, the supply chain for LOPRESSOR HCT is globally extensive, involving multiple pharmaceutical manufacturers, active pharmaceutical ingredient (API) suppliers, and distributors. Understanding the landscape of LOPRESSOR HCT suppliers is vital for pharmaceutical companies, healthcare providers, and stakeholders aiming to ensure drug availability, quality, and regulatory compliance. This analysis examines the key suppliers involved in the manufacturing and distribution of LOPRESSOR HCT, the global supply dynamics, and the implications for the pharmaceutical industry.

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Manufacturers of LOPRESSOR HCT

Brand and Generic Manufacturers

LOPRESSOR HCT is marketed primarily under the Lopressor HCT brand by Novartis. However, its formulation—propranolol hydrochloride combined with hydrochlorothiazide—is also available as a generic medication produced by multiple manufacturers. Generic manufacturers typically produce these drugs following stringent bioequivalence standards, enabling wider access and potentially lower prices.

Novartis

• Overview: As the patent holder and original manufacturer, Novartis maintains the primary production of Lopressor HCT. The company has a robust manufacturing network, including facilities in Europe, North America, and emerging markets.
• Supply Chain: Novartis sources APIs globally, utilizing a combination of high-quality suppliers across continents to meet production demands while adhering to Good Manufacturing Practices (GMP).

Generic Manufacturers

• Major Players: Several pharmaceutical companies, including Teva Pharmaceutical Industries, Sandoz (a Novartis division), Mylan (now part of Viatris), and Lupin, produce generic versions of LOPRESSOR HCT.

• Production Sites: These generics are produced across India, China, Eastern Europe, and North America, reflecting a diversified supply chain that mitigates risk and enhances global reach.

Key Considerations

• The presence of multiple generics increases supply resilience but also introduces variability in manufacturing standards, necessitating rigorous regulatory scrutiny.
• Companies often rely on third-party contract manufacturing organizations (CMOs) for API synthesis and finished-dose manufacturing.

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Active Pharmaceutical Ingredient (API) Suppliers

Propranolol Hydrochloride API

• Global Suppliers: Propranolol API is produced by several Chinese and Indian API manufacturers, such as Zhejiang Hisun Pharmaceutical, Shanghai Sinepharm, and Indian companies like Aurobindo Pharma.
• Quality and Regulation: Leading API producers comply with GMP standards, with many APIs certified by the U.S. FDA and EMA, ensuring safety and efficacy.

Hydrochlorothiazide API

• Leading Suppliers: Major API suppliers include Teva API, Mylan API, and Zhejiang Hisoar Pharmaceuticals. Indian and Chinese API producers dominate this segment due to cost advantages and capacity.
• Regulatory Status: Suppliers that export APIs to the U.S. and Europe typically hold certifications from regulatory agencies, ensuring compliance with international standards.

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Distribution Channels

• Pharmaceutical Distributors: Large distribution networks, like McKesson, Cardinal Health, and Alliance Healthcare, supply retail pharmacies and hospitals with LOPRESSOR HCT.
• Wholesaler Networks: These entities facilitate global and regional distribution, managing inventory, logistics, and regulatory documentation.
• Online Pharmacies: Increasingly, online platforms source generic LOPRESSOR HCT from certified manufacturers, expanding access in certain markets.

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Supply Chain Challenges and Risks

Regulatory Compliance

Global sourcing necessitates adherence to diverse regulatory standards, including FDA, EMA, and various national agencies. Non-compliance risks supply disruptions and legal repercussions.

API Supply Constraints

Dependence on API suppliers from China and India exposes manufacturers to geopolitical, trade, and quality risks. Recent export restrictions and supply chain disruptions (e.g., during the COVID-19 pandemic) have highlighted vulnerabilities.

Manufacturing Capacity and Quality

Limited manufacturing capacity or quality issues at any point in the supply chain can lead to shortages or recalls. Hence, ongoing quality assurance and capacity expansion investments are critical.

Pricing and Market Competition

Price pressures from generics and patent expirations influence supplier strategies. Cost-effective sourcing while maintaining high standards remains a balancing act for manufacturers.

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Regulatory and Market Considerations

• Patent Expiry: The patent for Lopressor HCT has long expired, enabling multiple producers to enter the market.
• Regulatory Approvals: Suppliers must ensure that their manufacturing processes and APIs meet regional regulatory approvals, which influence market access.
• Subsidiary and Partnership Agreements: Collaborations among pharmaceutical firms and licensing agreements influence supplier dynamics, especially in emerging markets.

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Key Industry Players

Company	Role	Market Region	Notes
Novartis	Original manufacturer	Global	Partnered with suppliers for API sourcing
Teva	Generic manufacturer	Global	Extensive distribution network
Mylan/Viatris	Generic manufacturer	Global	API and finished-dose manufacturing
Lupin	Indian generic manufacturer	Asia, Africa	Cost advantage, expanding markets
Zhejiang Hisun Pharmaceuticals	API supplier	China	Certified API producer
Aurobindo Pharma	API and generic producer	India	Significant market share

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Emerging Trends and Future Outlook

• Supply Chain Diversification: Increasing reliance on multiple API and finished-dose manufacturers minimizes disruption risks.
• Regulatory Harmonization: International standards streamline approval processes and enhance supplier credibility.
• Biopharmaceutical Alternatives: While transition prospects exist, current reliance on small-molecule APIs sustains supply chain dependency.
• Sustainability Initiatives: Suppliers investing in environmentally sustainable manufacturing are likely to gain preferential market access.

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Conclusion

The supply network for LOPRESSOR HCT involves a complex amalgamation of original and generic manufacturers, API suppliers predominantly from China and India, and extensive distribution channels. Ensuring a reliable, compliant supply chain requires constant vigilance to regulatory changes, geopolitical factors, and quality standards. Stakeholders seeking stability should prioritize diversified sourcing strategies, robust quality assurance, and strong regulatory relationships.

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Key Takeaways

• Diverse Supplier Base: The global presence of multiple manufacturers and API suppliers mitigates risks but requires diligent quality and compliance oversight.
• API Dependency: Heavy reliance on Chinese and Indian API producers underscores geopolitical risks; diversification is essential.
• Regulatory Vigilance: Compliance with international standards assures quality and market access, particularly for generics.
• Market Dynamics: Patent expirations have increased competition, influencing supplier strategies and pricing.
• Future Preparedness: Emphasizing sustainability, regulatory harmonization, and supply chain resilience will be vital for uninterrupted LOPRESSOR HCT supply.

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FAQs

1. Who are the leading manufacturers of LOPRESSOR HCT?
Novartis originally produced Lopressor HCT; numerous generic companies like Teva, Mylan (Viatris), and Lupin also manufacture the medication, primarily sourcing from API suppliers in China and India.

2. Where do API suppliers for LOPRESSOR HCT primarily operate?
Major API suppliers for propranolol and hydrochlorothiazide are predominantly based in China and India, with companies like Zhejiang Hisoar and Aurobindo Pharma leading the market.

3. How does supply chain diversification impact LOPRESSOR HCT availability?
Diversification reduces reliance on single sources, enhancing resilience against disruptions—critical amid geopolitical tensions and regulatory changes.

4. What regulatory challenges do LOPRESSOR HCT suppliers face?
Compliance with evolving GMP standards, obtaining necessary certifications (FDA, EMA), and managing cross-border regulatory approvals are ongoing challenges.

5. Will the supply chain for LOPRESSOR HCT evolve with emerging technological advancements?
Yes. Advances in manufacturing technology, digital quality assurance, and supply chain analytics are expected to improve transparency, efficiency, and resilience.

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Sources

1. Novartis official website. (2023). Product pipeline and manufacturing practices.
2. U.S. FDA Drug Approvals and Inspections. (2023).
3. Indian Pharmaceutical Association. Industry overview.
4. Chinese API Manufacturers Association. Market reports.
5. GlobalData. (2023). Pharmaceutical supply chain analysis.