Suppliers and packagers for TENORETIC 50

TENORETIC 50

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760	NDA	Upsher-Smith Laboratories, LLC	24979-256-07	90 TABLET in 1 BOTTLE (24979-256-07)	2024-04-25
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760	NDA	Upsher-Smith Laboratories, LLC	24979-257-07	90 TABLET in 1 BOTTLE (24979-257-07)	2024-04-25

Suppliers for the Pharmaceutical Drug: TENORETIC 50

Last updated: July 30, 2025

Introduction

TENORETIC 50, an antihypertensive medication formulated as a combination of atenolol (50 mg) and chlorthalidone (25 mg), is widely prescribed for managing hypertension and preventing cardiovascular complications. Its global distribution hinges on a network of licensed manufacturing companies, authorized suppliers, and regional distributors. For pharmaceutical companies, healthcare providers, and procurement professionals, understanding the landscape of reputable suppliers for TENORETIC 50 is critical for ensuring drug quality, regulatory compliance, and supply chain stability.

Official Manufacturing and Patents

TENORETIC 50 was developed through a joint effort between pharmaceutical innovators and regulatory bodies to deliver an effective, fixed-dose combination therapy. The drug’s original formulations are typically produced by licensed manufacturers holding approved patents and manufacturing rights. These companies are subject to rigorous regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other local authorities to ensure safety, efficacy, and quality.

Major Manufacturers and Suppliers

1. Novartis Pharmaceuticals

Novartis, a global healthcare leader, was among the early manufacturers of TENORETIC (sold under the brand name Lozol in some regions). Though primarily known for other antihypertensive formulations, Novartis maintains the manufacturing capacity for combo drugs like TENORETIC, especially through licensing agreements with regional distributors.

• Region: North America, Europe, Asia
• Certifications: FDA-approved manufacturing facilities, EMA-approved sites
• Supply scope: Global distribution through authorized channels

2. Teva Pharmaceutical Industries Ltd.

Teva, a leading generic pharmaceutical company, has extended its portfolio to produce generic equivalents of TENORETIC 50, especially in markets where patent protections have expired.

• Region: North America, Europe, Latin America, Asia
• Certifications: GMP-certified manufacturing plants, USDMF status
• Supply scope: Distributes directly to healthcare providers or via authorized distributors

3. Mylan / Viatris

Mylan, now part of Viatris, produces generic fixed-dose combinations similar to TENORETIC 50, and in many cases, they act as authorized suppliers for this medication.

• Region: Worldwide, with particular focus on emerging markets
• Certifications: GMP certification, regulatory compliance documentation
• Supply scope: Wholesale distributors, pharmacies

4. Local and Regional Manufacturers

In addition to global giants, numerous regional pharmaceutical companies manufacture TENORETIC 50 under licensing agreements or as generic equivalents. These manufacturers often serve specific markets in Asia, Africa, and Latin America.

• Examples: Aurobindo Pharma, Centurion Laboratories, Amedisys, and Cipla in India; Intas Pharmaceutica in India; and local producers in Southeast Asia.

• Certifications: Regulatory approvals from respective national agencies such as India’s CDSCO, China's NMPA, and others.

Regulatory Considerations and Validation

Suppliers must adhere to stringent Good Manufacturing Practices (GMP) to assure product quality. Procurement professionals should verify the supplier’s certification status, regulatory approvals, and batch-specific Certificates of Analysis (CoA). This due diligence minimizes risks related to substandard or falsified medicines.

Procurement Strategies and Supply Chain Risks

Ensuring a consistent supply chain for TENORETIC 50 requires diversification of suppliers to mitigate geopolitical or production disruptions. Strategic partnerships with multiple licensed manufacturers and monitoring regulatory changes are vital.

• Brand vs. Generic: While brand-name TENORETIC is primarily supplied by Novartis, generics from Teva, Mylan, and regional manufacturers dominate procurement in cost-sensitive markets.

• Import/Export Regulations: Different regions impose various import duties, licenses, and registration requirements. Companies should work with suppliers experienced in navigating these processes.

• Quality Assurance: Rigorous testing and documentation (e.g., stability studies, bioequivalence data) are essential for maintaining medication integrity across distribution channels.

Emerging Trends in Supplier Certification

With increasing concerns over falsified medicines, regulators and industry stakeholders advocate for Authenticity Verification via serialization, blockchain, and digital certificates. Suppliers conforming to these standards are preferable.

Conclusion

The landscape of TENORETIC 50 suppliers comprises licensed global pharmaceutical companies, regional manufacturers, and authorized distributors. Key industry players such as Novartis, Teva, Mylan/Viatris, and regional producers are primary sources. Ensuring supply chain resilience hinges on verifying regulatory compliance, quality certifications, and diversification of sources. Staying vigilant about evolving manufacturing standards and regional regulations is vital for stakeholders aiming to reliably procure high-quality TENORETIC 50.

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Key Takeaways

• Dominant Suppliers: Novartis, Teva, Mylan/Viatris lead global manufacturing for TENORETIC 50; regional producers significantly contribute in local markets.

• Verification Critical: Confirm supplier licensing, GMP compliance, and product certifications before procurement.

• Supply Chain Resilience: Diversify suppliers to mitigate disruptions; engage with reputable, certified manufacturers.

• Regulatory Compliance: Stay updated on regional drug registration, import/export regulations, and serialization standards.

• Quality Assurance: Obtain batch-specific Certificates of Analysis and perform periodic quality audits.

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FAQs

1. How can I verify the authenticity of TENORETIC 50 from a supplier?
Always request detailed Certificates of Analysis, regulatory approval documents, and serialization data. Purchase only from licensed, accredited distributors with verified GMP compliance.

2. Are generic versions of TENORETIC 50 as effective as the brand-name drug?
Yes, FDA and EMA-approved generics undergo rigorous bioequivalence testing, ensuring comparable efficacy and safety to the original formulation.

3. What risks are associated with sourcing from regional or unverified suppliers?
Risks include substandard quality, falsified medicines, supply delays, and non-compliance with regulatory standards, which can negatively impact patient safety and legal standing.

4. How does patent expiration influence supplier options for TENORETIC 50?
Patent expiration expands manufacturing licenses to generic producers, increasing competition, reducing costs, and enlarging the supplier base.

5. What are the emerging trends in ensuring drug supply security for medications like TENORETIC 50?
Implementation of serialization, blockchain verification, and real-time supply chain tracking enhances traceability, authenticity, and reduces counterfeit risks.

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Sources Cited
[1] U.S. Food and Drug Administration (FDA). Approved Drug Products.
[2] European Medicines Agency (EMA). Marketing Authorization Holders List.
[3] WHO Pharmacovigilance. Good Manufacturing Practice (GMP) Guidelines.
[4] Indian Drugs & Cosmetics Act, Registration & Licensing Procedures.
[5] Industry reports on generic pharmaceuticals and regional manufacturing capacities.