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Suppliers and packagers for OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
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OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
Suppliers for the Pharmaceutical Drug: Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide
Introduction
The combination of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide represents a triple antihypertensive therapy widely used in clinical treatment for managing high blood pressure. As the demand for this combination therapy increases globally, identifying reliable suppliers is paramount for pharmaceutical companies, healthcare providers, and distributors to ensure consistent supply, quality control, and compliance with regulatory standards.
This comprehensive review examines the key suppliers across various regions, their manufacturing capabilities, market positions, and strategic considerations, providing industry stakeholders with actionable insights into the supply landscape.
Overview of the Pharmaceutical Components
Olmesartan Medoxomil: An angiotensin II receptor blocker (ARB), used predominantly for treating hypertension and improving cardiovascular outcomes. It is produced through complex chemical synthesis involving selective reactions to ensure purity and bioavailability.
Amlodipine: A calcium channel blocker (CCB) used in hypertension and angina, with a well-established manufacturing process that demands high-quality excipients and stringent quality controls.
Hydrochlorothiazide: A thiazide diuretic critical for reducing blood pressure; its production involves multiple steps with a focus on impurity profile and formulation stability.
The combination's production relies heavily on specialists with proven expertise in synthesizing these active pharmaceutical ingredients (APIs), particularly given the regulatory scrutiny over quality and efficacy.
Global Suppliers of Olmesartan Medoxomil
Major Producers
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Sun Pharmaceutical Industries Ltd. (India)
- A leading manufacturer with a robust API portfolio, Sun Pharma produces Olmesartan Medoxomil at scale. Their facilities adhere to USFDA, EMA, and other international standards, validating their position as a global supplier [1].
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Hetero Drugs Ltd. (India)
- Known for its extensive API manufacturing capabilities, Hetero supplies Olmesartan Medoxomil to multinational pharmaceutical companies. Their facilities are approved by global health authorities, enabling broad distribution.
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Mylan N.V. (United States/India)
- As a key producer, Mylan offers Olmesartan Medoxomil both as an API and in finished dosage forms, with manufacturing plants certified by USFDA and other agencies.
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Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
- A major Chinese pharmaceutical producer, Huahai supplies APIs for various antihypertensive drugs, including Olmesartan Medoxomil, leveraging cost-effective manufacturing.
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Aurobindo Pharma Limited (India)
- With a significant API portfolio, Aurobindo’s facilities meet global standards, serving both domestic and international markets.
Emerging Suppliers
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Torrent Pharmaceuticals (India)
- Offering competitive pricing, Torrent supplies Olmesartan Medoxomil with worldwide regulatory approvals.
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Jubilant Life Sciences (India)
- Known for high-quality APIs, Jubilant's manufacturing facilities are certified under international standards.
Leading Suppliers of Amlodipine
Key Global Suppliers
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AstraZeneca (United Kingdom/Global)
- The original patent holder, AstraZeneca is a primary supplier of branded and generic Amlodipine, with established manufacturing facilities supporting extensive supply chains.
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Sanjose Pharmaceutical (India)
- A significant API manufacturer specializing in antihypertensive agents, including Amlodipine, with a focus on quality compliance.
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Heumann Pharma (Germany/India)
- Offers high-quality Amlodipine APIs and generics with compliance to European regulatory standards.
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Hetero Drugs Ltd. (India)
- As noted, Hetero supplies a wide range of antihypertensive APIs, including Amlodipine, with a global distribution network.
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Mylan N.V.
- A key player with extensive manufacturing capacity and regulatory approvals for Amlodipine APIs.
Regional Suppliers
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Lupin Limited (India)
- Facilitates regional access to affordable Amlodipine, complying with international standards.
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Cadila Healthcare (India)
- Known for production of reliable cardiovascular APIs, including Amlodipine.
Prominent Suppliers of Hydrochlorothiazide
Major Producing Entities
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Mylan N.V. (United States/India)
- One of the largest suppliers, providing Hydrochlorothiazide globally. Their manufacturing adheres to stringent quality standards [2].
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Teva Pharmaceutical Industries Ltd. (Israel)
- A leading generic medicine producer, Teva supplies Hydrochlorothiazide across multiple markets with high compliance standards.
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Lupin Limited (India)
- Known for its cost-effective production and global reach, Lupin offers high-quality Hydrochlorothiazide APIs.
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Sun Pharmaceutical Industries Ltd. (India)
- Also a key supplier, leveraging extensive API manufacturing infrastructure.
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Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
- A significant Chinese API manufacturer, supplying Hydrochlorothiazide to international markets.
Noteworthy Regional Players
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Lannett Company, Inc. (United States)
- Supplies Hydrochlorothiazide API for the North American market.
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Sino Biopharmaceutical Limited (Hong Kong/China)
- Enters the regional supply chain with competitive offerings.
Supply Chain Considerations
Regulatory Compliance: Suppliers operating under USFDA, EMA, PMDA, and other regulatory approvals minimize compliance risks. Indian manufacturers dominate globally, with many holding multiple accreditations, notably from USFDA and EDQM [3].
Manufacturing Capacity & Lead Times: Leading companies such as Sun Pharma, Aurobindo, and Mylan possess large-scale facilities capable of consistent supply, crucial amid or post-pandemic.
Pricing & Cost Efficiency: Chinese suppliers like Zhejiang Huahai and Indian producers often offer competitive pricing; however, geopolitical and trade considerations impact sourcing decisions.
Quality Assurance & Certifications: Suppliers with Good Manufacturing Practice (GMP) accreditation, validated by rigorous audits, ensure pharmaceutical-grade quality vital for combination drugs.
Distribution & Logistics: Multinational corporations leverage global logistics networks, securing timely and compliant distribution.
Strategic Implications for Stakeholders
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For Manufacturers: Diversification of supplier base mitigates risks associated with geopolitical, regulatory, and capacity constraints. Establishing relationships with multiple high-quality suppliers ensures uninterrupted production and regulatory compliance.
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For Distributors: Sourcing from suppliers with proven quality, compliance, and capacity guarantees supply stability, particularly critical for high-demand combination therapies.
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For Regulators & Policymakers: Monitoring supply chain integrity facilitates avoiding shortages and maintaining drug safety standards. Promoting transparency and accreditation among suppliers enhances overall industry resilience.
Key Takeaways
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The supply landscape for Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide is predominantly driven by Indian, Chinese, and global pharmaceutical manufacturing giants with extensive GMP-certified facilities.
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Indian pharmaceutical companies like Sun Pharma, Aurobindo, and Lupin cement their position as reliable, cost-effective suppliers with strong compliance track records.
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Chinese manufacturers such as Zhejiang Huahai contribute significantly to the global supply chain, particularly for cost-sensitive markets.
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Regulatory adherence and quality certifications are critical differentiators among suppliers, notably for APIs used in combination drugs.
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Supply chain diversification remains a key strategy to mitigate risks associated with geopolitical tensions and manufacturing disruptions.
FAQs
1. Which manufacturers are the leading global suppliers of Olmesartan Medoxomil?
Leading suppliers include Sun Pharmaceutical Industries (India), Hetero Drugs (India), Mylan (US/India), Zhejiang Huahai Pharmaceutical (China), and Aurobindo Pharma (India). These companies offer APIs meeting international regulatory standards.
2. Are Chinese API manufacturers compliant with global quality standards?
Yes, many Chinese manufacturers such as Zhejiang Huahai have significant approval from USFDA, EMA, and other authorities, ensuring the quality of their APIs aligns with global standards.
3. How do Indian pharmaceutical companies compare in API manufacturing?
Indian companies like Sun Pharma, Aurobindo, and Lupin are globally recognized for high-quality, cost-effective APIs. Many hold multiple international certifications, supporting their global supply capabilities.
4. What are the key regulatory considerations when sourcing these APIs?
Suppliers with USFDA, EMA, EDQM, and other certifications are preferred. Regulatory compliance ensures the APIs meet quality, purity, and safety standards crucial for pharmaceutical applications.
5. How does supply chain diversification benefit pharmaceutical companies?
Diversification reduces dependency on a single supplier or region, minimizes risks related to geopolitical issues, supply disruptions, and regulatory changes, ensuring a steady supply of critical APIs.
References
[1] Sun Pharmaceutical Industries Ltd. Regulatory filings, 2023.
[2] Mylan N.V. API manufacturing and certification info, 2023.
[3] European Directorate for the Quality of Medicines & HealthCare (EDQM), Certified API manufacturers, 2023.
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