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Suppliers and packagers for generic pharmaceutical drug: AZILSARTAN KAMEDOXOMIL
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AZILSARTAN KAMEDOXOMIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796 | NDA | Azurity Pharmaceuticals, Inc. | 60631-040-30 | 30 TABLET in 1 BOTTLE (60631-040-30) | 2013-02-01 |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796 | NDA | Azurity Pharmaceuticals, Inc. | 60631-040-77 | 7 TABLET in 1 BOTTLE (60631-040-77) | 2013-02-01 |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796 | NDA | Azurity Pharmaceuticals, Inc. | 60631-080-30 | 30 TABLET in 1 BOTTLE (60631-080-30) | 2013-02-01 |
| Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796 | NDA | Azurity Pharmaceuticals, Inc. | 60631-080-77 | 7 TABLET in 1 BOTTLE (60631-080-77) | 2013-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Azilsartan Kamedoxomil
Introduction
Azilsartan Kamedoxomil is an angiotensin II receptor blocker (ARB) used primarily for treating hypertension. Known for its high affinity and selectivity for the AT1 receptor, azilsartan has gained recognition for its efficacy in blood pressure management. The demand for effective antihypertensive agents has amplified the importance of reliable suppliers in the pharmaceutical supply chain. This article explores key suppliers involved in the manufacturing and distribution of azilsartan kamedoxomil, highlighting their roles, market dynamics, regulatory considerations, and strategic outlooks.
Manufacturers and API Suppliers
1. Major Pharmaceutical Companies Producing Azilsartan Kamedoxomil
The synthesis of azilsartan kamedoxomil involves complex chemical processes necessitating high-quality active pharmaceutical ingredient (API) production. Several pharmaceutical companies globally are authorized to manufacture and supply azilsartan APIs, either directly for their formulations or to third-party API producers.
- Shionogi & Co., Ltd. (Japan)
As the originator of azilsartan, Shionogi pioneered its development and maintains control of its patent rights. The company is engaged in manufacturing the API and finished dosage forms. While primarily domestic, Shionogi ships APIs internationally, particularly to licensed partners and generic manufacturers.
- MSD (Merck & Co.)
In collaboration with original developers, MSD (known as Merck in the United States and Canada) has played a significant role in marketing azilsartan-based products. MSD sources APIs through licensed manufacturing agreements, emphasizing consistent quality standards.
- Teva Pharmaceutical Industries Ltd. (Israel)
A leading generic drug manufacturer, Teva has developed capabilities to produce azilsartan APIs, especially following patent expirations in various markets. The company supplies these to regional generics manufacturers and pharmacies.
- Lupin Limited (India)
Lupin is recognized for its robust API manufacturing infrastructure and has developed azilsartan kamedoxomil APIs for domestic and export markets, especially targeting emerging markets.
- Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)
While not always direct API producers, Chinese companies like Hisoar have scaled API production, supplying affordable azilsartan products to global markets.
2. API Manufacturers and Suppliers Landscape
The API supply chain for azilsartan kamedoxomil is geographically diverse. Asian conglomerates, especially from India and China, dominate generic API production, driven by cost efficiencies and established API manufacturing infrastructure. These APIs often meet international standards such as API Quality Guidelines set by the ICH (International Council for Harmonisation).
Regulatory and Quality Considerations
Suppliers must adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP), to ensure API quality, potency, and purity. Regulatory authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and health authorities in emerging markets scrutinize API suppliers’ manufacturing facilities through rigorous inspections.
Distribution and Supply Chain Dynamics
Post-API production, the supply chain extends across distributors and pharmaceutical manufacturers. Multinational pharmaceutical firms often maintain their own supply chains, while generic producers rely on third-party distributors. The global COVID-19 pandemic underscored vulnerabilities in supply chains, prompting a shift towards diversifying suppliers and increasing inventory buffers.
Market Trends and Strategic Outlook
The market for azilsartan kamedoxomil remains steady, driven by the global prevalence of hypertension. Patent expirations in various jurisdictions have facilitated entry of generic suppliers, expanding the supplier base. Strategic alliances, licensing agreements, and vertical integration are prevalent, aiming to secure a reliable API supply.
Emerging markets, particularly in Asia and Africa, exhibit increasing demand for affordable antihypertensive medications, fostering growth among regional API manufacturers. However, with rising regulatory scrutiny and quality demands, suppliers investing in GMP compliance and quality assurance are positioned for sustained growth.
Regulatory and Patent Landscape
Patent protections impact supplier dynamics; patent expirations in key markets like the U.S. (around 2017–2018) have unlocked opportunities for generic API manufacturers. Regulatory approval for APIs often involves prior registration of the finished drugs. Consequently, suppliers must align their quality standards to facilitate regulatory clearance for licensed formulations.
Competitive Landscape
The competitive landscape features a handful of major API producers with high-quality manufacturing capabilities. Competition is intensified by cost pressures, regulatory compliance requirements, and market penetration strategies. Leading suppliers invest heavily in R&D, process optimization, and quality management systems to differentiate themselves.
Challenges and Opportunities
- Supply Chain Resilience: Dependence on Asian API manufacturers entails geopolitical and logistical risks. Diversification and local manufacturing initiatives are trending to mitigate disruptions.
- Regulatory Complexity: Navigating global regulatory standards can delay market entry. Suppliers with robust regulatory expertise gain a competitive advantage.
- Quality Assurance: Ensuring API consistency and meeting evolving quality standards remains paramount amid increasing scrutiny.
Conclusion
The supply of azilsartan kamedoxomil APIs is characterized by a globally dispersed network of manufacturers, predominantly led by Asian API producers and licensed pharmaceutical companies. While original innovators like Shionogi maintain control over key formulations, generic manufacturers from China, India, and Israel have expanded their market share. Navigating regulatory landscapes, emphasizing quality standards, and ensuring supply chain resilience are critical for sustained market presence.
Key Takeaways
- Azilsartan kamedoxomil's API supply chain is driven by Asian manufacturers, with India and China leading global production.
- Original developers like Shionogi retain control over proprietary formulations, while generics companies expand through licensed manufacturing.
- Regulatory compliance, particularly GMP standards, is critical for API approval and market access.
- Supply chain diversification and strengthening quality assurance are vital amid recent disruptions.
- The expiration of patents has increased market entry of generic API suppliers, intensifying competition.
FAQs
1. Who are the leading global suppliers of azilsartan kamedoxomil API?
Leading API suppliers include Shionogi (Japan), Lupin (India), Zinho Hisoar (China), and Teva (Israel). These companies possess the manufacturing capacity and regulatory approvals necessary for global distribution.
2. How do patent expirations influence the supplier landscape?
Patent expirations create opportunities for generic API manufacturers to enter the market, expanding the supplier base and increasing competition, especially in low-cost manufacturing regions like India and China.
3. What regulatory standards must azilsartan API suppliers meet?
Suppliers must comply with GMP standards set by authorities like the FDA, EMA, and country-specific agencies. These standards ensure high-quality, safe, and efficacious APIs suitable for global markets.
4. How does geopolitical risk impact azilsartan API supply chains?
Geopolitical factors, including trade policies, tariffs, and regional stability, can disrupt supply chains. Diversification across regions and investing in local manufacturing are strategies to mitigate these risks.
5. What future trends are shaping azilsartan kamedoxomil API supply?
Increasing focus on supply chain resilience, regulatory harmonization, and quality assurance will influence future supplier strategies. Growing demand in emerging markets will further stimulate API manufacturing capacity expansion.
References
[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: API Quality Standards.
[2] International Council for Harmonisation (ICH). Quality Guidelines.
[3] Market research reports on antihypertensive drug manufacturing.
[4] Corporate disclosures from Shionogi, Lupin, Teva, and Hisoar.
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