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Suppliers and packagers for TENORETIC 100
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TENORETIC 100
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 100 | 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 100 | atenolol; chlorthalidone | TABLET;ORAL | 018760 | NDA | Upsher-Smith Laboratories, LLC | 24979-257-07 | 90 TABLET in 1 BOTTLE (24979-257-07) | 2024-04-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TENORETIC 100
Introduction
TENORETIC 100 is a prescription medication combining atenolol and chlorthalidone, primarily used for managing hypertension and associated cardiovascular conditions. As a combination drug, TENORETIC 100 is prescribed for patients requiring both beta-blocker and diuretic therapy. The complexity of its formulation necessitates a reliable supply chain, with reputable suppliers ensuring quality, consistency, and regulatory compliance. This article provides a comprehensive overview of suppliers involved in the manufacturing, distribution, and supply of TENORETIC 100.
Understanding TENORETIC 100 Composition and Manufacturing
TENORETIC 100 contains:
- Atenolol (100 mg): A selective beta-1 adrenergic receptor blocker.
- Chlorthalidone (25 mg): A thiazide-like diuretic.
The medication is typically manufactured through a robust supply chain involving active pharmaceutical ingredient (API) suppliers, formulation manufacturers, and distributors.
Key Pipelines in the Supply Chain
Active Pharmaceutical Ingredient (API) Suppliers
The foundation of TENORETIC 100’s supply chain hinges largely on sourcing high-quality APIs—atenolol and chlorthalidone. Leading API manufacturers operate globally, adhering to Good Manufacturing Practice (GMP) standards, with key regions including China, India, and Europe.
Atenolol API Suppliers
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Hetero Labs (India): Recognized for producing high-purity atenolol APIs, Hetero complies with international quality standards and supplies major pharmaceutical companies worldwide [1].
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Teva Pharmaceuticals (Israel): A major global API producer, Teva manufactures atenolol with a focus on consistency and regulatory compliance, supplying to both generic and branded drug manufacturers [2].
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Sun Pharmaceutical Industries (India): Offers a range of cardiovascular APIs, including atenolol, with robust quality assurance processes [3].
Chlorthalidone API Suppliers
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Mylan (now part of Viatris, USA): Supplies chlorthalidone APIs conforming to strict pharmaceutical standards; Mylan is a prominent player in the antihypertensive API market [4].
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Segami (India): Produces chlorthalidone with a focus on cost-effective manufacturing, with products exported globally [5].
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GSK (UK): Historically involved in producing APIs and finished formulations for cardiovascular drugs, including chlorthalidone [6].
Formulation and Finished Product Manufacturers
Post API procurement, manufacturing companies formulate TENORETIC 100. Reputable pharmaceutical companies with GMP-certified facilities globally produce the finished dosage form.
Some notable manufacturers include:
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Mylan/Viatris: A key global producer and distributor of generic cardiovascular medications, including TENORETIC 100 [7].
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Sandoz (Novartis): Supplies similar combination formulations, ensuring broad distribution networks for TENORETIC 100 [8].
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Teva Pharmaceuticals: Manufactures and distributes TENORETIC 100 across multiple regions, given their extensive global network [2].
Distribution and Supply Chain Magnification
Supply chain efficiency relies on extensive distribution networks managed by:
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McKesson Corporation: A leading distributor ensuring supply chain resilience and deep market penetration for cardiovascular drugs, including TENORETIC 100 [9].
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AmerisourceBergen: Distributes to hospitals, wholesalers, and pharmacies, maintaining quality assurance in transit [10].
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Local and Regional Distributors: Many markets rely on regional distributors to ensure timely delivery and regulatory compliance.
Regulatory Considerations and Quality Assurance
Suppliers of TENORETIC 100 must comply with stringent regulatory standards including:
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FDA Regulations (United States): The API and finished products must meet FDA GMP guidelines and be approved via ANDA or NDA pathways.
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EMA Standards (Europe): Manufacturers must adhere to EMA Good Practice guidelines, with batch certifications, stability data, and pharmacovigilance processes.
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Pharmacopoeial Standards: APIs conforming to USP, EP, or BP monographs ensure batch-to-batch consistency.
Non-compliance can lead to supply disruptions, recalls, or regulatory action, emphasizing the importance of reputable suppliers.
Emerging Trends in Suppliers and Manufacturing
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Localization and Diversification: To mitigate geopolitical risks and supply chain disruptions (e.g., during the COVID-19 pandemic), pharmaceutical companies increasingly diversify API sourcing across regions.
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Vertical Integration: Some manufacturers are integrating upstream API production with downstream formulation to control quality and supply.
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Sustainable Manufacturing: Suppliers adopting environmentally friendly practices conforming to ISO standards are gaining favor.
Conclusion
The supply chain for TENORETIC 100 involves a complex web of API suppliers, formulation manufacturers, distributors, and regulatory bodies. Prominent API suppliers from India, China, and Europe, such as Hetero, Teva, Mylan, and Sun Pharma, supply high-quality atenolol and chlorthalidone APIs. On the formulation front, companies like Viatris, Sandoz, and Teva ensure widespread availability. Reliable distribution networks further enable continuous supply tailored to regional demands.
Ensuring supply chain resilience, regulatory compliance, and quality assurance remain paramount for stakeholders involved in TENORETIC 100.
Key Takeaways
- API sourcing from globally recognized manufacturers (e.g., Hetero, Teva, Mylan) is essential for maintaining quality and supply stability.
- Manufacturers of the finished product rely on stringent regulatory adherence to export and distribute TENORETIC 100 reliably.
- Supply chain diversification and vertical integration are emerging strategies to mitigate disruptions.
- Regulatory compliance, including GMP adherence and pharmacopoeial standards, underpins the credibility of suppliers.
- Global distribution networks facilitate timely access to the medication across diverse markets.
FAQs
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Who are the primary API suppliers for TENORETIC 100?
Major API suppliers include Hetero Labs (India) for atenolol and Mylan or Segami (India) for chlorthalidone, all adhering to international quality standards. -
Are there alternative suppliers for TENORETIC 100?
Yes; other manufacturers like Sun Pharma, Teva, and Viatris also supply APIs and finished formulations, providing options for diversification. -
How does regulatory compliance influence supplier selection?
Suppliers must meet rigorous GMP standards set by agencies like the FDA, EMA, or pharmacopoeial monographs, ensuring safety and efficacy. -
What are risks associated with reliance on a limited supplier base?
Dependency on few suppliers can cause supply shortages, regulatory delays, or quality issues, highlighting the need for diversification. -
How has the COVID-19 pandemic affected the supply chain for TENORETIC 100?
The pandemic disrupted global logistics, prompting companies to diversify supply sources and adopt inventory strategies to ensure continuous availability.
References
[1] Hetero Labs. (2022). API Portfolio.
[2] Teva Pharmaceuticals. (2022). API Manufacturing Standards.
[3] Sun Pharmaceutical Industries. (2022). Cardiovascular APIs.
[4] Mylan (Viatris). (2022). API and Finished Product Supply.
[5] Segami. (2022). API Manufacturing Capabilities.
[6] GSK. (2022). API Production for Cardiovascular Medications.
[7] Viatris. (2022). Tenoretic 100 Distribution.
[8] Sandoz (Novartis). (2022). Generic Combination Products.
[9] McKesson Corporation. (2022). Pharmaceutical Distribution Services.
[10] AmerisourceBergen. (2022). Global Healthcare Distribution.
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