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Suppliers and packagers for HYZAAR
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HYZAAR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-139-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-139-01) | 2021-06-01 |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-139-02 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-139-02) | 2021-06-01 |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-140-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-140-01) | 2021-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: HYZAAR
Introduction
HYZAAR is a prescription medication combining losartan potassium and hydrochlorothiazide, used primarily for the treatment of hypertension and reduction of cardiovascular risks. As a fixed-dose combination, HYZAAR’s manufacturing process hinges on sourcing high-quality active pharmaceutical ingredients (APIs) and excipients from reliable suppliers. Understanding the supplier landscape for HYZAAR is crucial for pharmaceutical companies, stakeholders, and healthcare providers aiming for consistent drug quality and supply chain resilience.
Manufacturing Components of HYZAAR
HYZAAR’s formulation comprises two main APIs:
- Losartan potassium: An angiotensin II receptor blocker (ARB)
- Hydrochlorothiazide (HCTZ): A diuretic
The integrity and efficacy of HYZAAR depend on the sourcing of these APIs, as well as excipients used in tablet production.
Major Suppliers of Losartan Potassium
Losartan potassium is a generic API widely produced by numerous manufacturers globally. Leading suppliers include:
- Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe is a pioneer in developing losartan and remains a significant supplier through licensing and direct manufacturing. - Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
A prominent player known for large-scale manufacturing and exporting losartan and other ARBs. - Sandoz (Novartis)
Sandoz supplies generic APIs, including losartan, through its extensive global manufacturing network. - Aurobindo Pharma (India)
A key supplier in the generic drugs market, with robust capacity for ARB APIs. - Mylan (now part of Viatris)
Offers losartan APIs and finished formulations worldwide. - Himfos (India)
Specialized in producing high-quality ARB APIs, including losartan.
Regulatory considerations:
Suppliers must meet stringent GMP standards and obtain regulatory approvals such as FDA, EMA, or other national agencies. The quality of losartan from these suppliers impacts the safety and efficacy of HYZAAR.
Major Suppliers of Hydrochlorothiazide
HCTZ production is highly industrialized, with key API suppliers including:
- Hikma Pharmaceuticals
A global leader in generating high-purity hydrochlorothiazide with extensive manufacturing capabilities. - Hikal Limited (India)
Produces hydrochlorothiazide with certifications acceptable to regulators globally. - Teva Pharmaceuticals
Supplies hydrochlorothiazide both as an API and in finished dosages. - Mitsubishi Tanabe Pharma
Also supplies hydrochlorothiazide as part of their cardiovascular portfolio. - Himfos (India)
Known for producing high-quality thiazide diuretics.
Regulatory compliance:
Suppliers must adhere to Good Manufacturing Practices (GMP) and ensure APIs meet pharmacopoeial standards, such as USP or EP.
Excipients and Additional Components
In addition to APIs, excipients like binders, fillers, and disintegrants are sourced from reputable suppliers including:
- Evonik Industries
- FMC Corporation
- Colorcon
Their role is critical in ensuring tablet stability, bioavailability, and patient safety.
Supply Chain Dynamics and Risks
The global supply chain for HYZAAR involves complex coordination across multiple manufacturers and regulatory landscapes. The following factors influence supplier viability:
- Regulatory Compliance: Regulatory shifts can lead to supplier audits, approvals, and potential batch rejections.
- Manufacturing Capacity: Some suppliers face capacity constraints, impacting the availability of APIs especially during increased demand.
- Geopolitical Risks: Trade restrictions or sanctions, particularly involving Chinese and Indian suppliers, can disrupt the supply chain.
- Quality Assurance: Ensuring batches meet specifications is essential; subpar quality can lead to recalls or regulatory action.
Supply disruptions have historically resulted from quality issues, manufacturing outages, and political factors, emphasizing the need for diversified supplier sourcing.
Emerging Trends in HYZAAR Supplier Landscape
- Localization and Diversification: Companies are shifting towards multiple sourcing regions to reduce dependence on a single country, especially post-pandemic and amid geopolitical tensions.
- Use of Contract Manufacturing Organizations (CMOs): Pharma firms increasingly leverage CMOs for API production, emphasizing quality and capacity.
- Regulatory Harmonization: Suppliers maintaining compliance with international standards facilitate global distribution of HYZAAR.
Key Players and Market Share
While exact market share data for API suppliers of HYZAAR remains proprietary, top global players dominate, notably those with decades-long GMP compliance and extensive R&D capabilities.
Mitsubishi Tanabe, Zhejiang Huahai, and Hikma dominate API supplies for losartan and hydrochlorothiazide, respectively. Their ability to scale and maintain quality influences HYZAAR's global availability.
Conclusion
The supplier landscape for HYZAAR is characterized by a diverse network of global API producers specializing in losartan potassium and hydrochlorothiazide. Leading suppliers operate within stringent regulatory frameworks, ensuring that product quality remains within pharmacopeial standards. As geopolitical, regulatory, and market forces evolve, pharmaceutical companies must maintain a strategic approach, securing multiple high-quality sources, and continuously monitoring supply chain stability to ensure uninterrupted medication access.
Key Takeaways
- Diversify supplier base for losartan and hydrochlorothiazide to mitigate supply disruptions and regulatory risks.
- Prioritize suppliers with international certifications (FDA, EMA, WHO GMP) to ensure consistent quality.
- Monitor geopolitical and regulatory developments impacting Asian API manufacturing hubs, especially China and India.
- Leverage relationships with CMOs to enhance manufacturing flexibility and capacity.
- Implement robust supply chain oversight for maintaining API quality and ensuring compliance with evolving standards.
FAQs
1. Who are the primary global suppliers of losartan potassium?
Major suppliers include Mitsubishi Tanabe Pharma, Zhejiang Huahai Pharmaceutical, Sandoz (Novartis), Aurobindo Pharma, and Mylan (Viatris). These companies produce high-quality losartan APIs meeting international standards.
2. How does supplier quality impact the safety of HYZAAR?
Supplier quality directly influences API purity, batch consistency, and overall drug efficacy. Substandard APIs can lead to ineffective medication or adverse reactions, risking patient safety and regulatory repercussions.
3. Are there regional differences in API sourcing for HYZAAR?
Yes. While India and China are prominent API producers globally, increasing focus is placed on diversifying sources across North America, Europe, and other regions to reduce dependency.
4. What are the main regulatory considerations for API suppliers of HYZAAR?
Suppliers must obtain GMP certification from authorities like the FDA and EMA, comply with pharmacopoeial standards, and participate in regular audits to maintain approvals for global markets.
5. How might geopolitical tensions affect the supply chain of HYZAAR?
Trade restrictions, tariffs, or sanctions targeting API-producing countries can delay or limit supply, emphasizing the need for supply chain diversification and contingency planning.
Sources
[1] Clarivate Data, "Global API Manufacturers," 2022.
[2] Deloitte, "Supply Chain Risks in Pharmaceutical Manufacturing," 2021.
[3] European Medicines Agency, "Regulatory Standards for API Manufacturers," 2022.
[4] Pharmacopoeia Standards, USP and EP Monographs for Losartan and Hydrochlorothiazide, 2022.
[5] IMS Health, "Global API Market Overview," 2022.
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