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Suppliers and packagers for avapro
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avapro
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757 | NDA | Sanofi-Aventis U.S. LLC | 0024-5851-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5851-30) | 2013-01-01 |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757 | NDA | Sanofi-Aventis U.S. LLC | 0024-5852-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30) | 2013-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AVAPRO
Introduction
AVAPRO, whose generic name is irbesartan, is an angiotensin II receptor blocker (ARB) primarily used in the treatment of hypertension and diabetic nephropathy. Since its introduction, AVAPRO has become part of critical cardiovascular and renal therapies worldwide. Its commercial success hinges on a robust and reliable supply chain, involving multiple suppliers across the pharmaceutical manufacturing ecosystem. This article offers a comprehensive overview of the key suppliers for AVAPRO, detailing the manufacturing landscape, regulatory considerations, and market dynamics that influence supply stability.
Manufacturers of the Active Pharmaceutical Ingredient (API)
The core of AVAPRO's supply chain lies in the production of irbesartan's API. Several global pharmaceutical companies are involved in API synthesis, either directly manufacturing or sourcing from specialized API producers.
1. Major API Producers
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Hetero Labs Ltd.
An India-based manufacturer, Hetero is among the largest producers of generic ARBs, including irbesartan. The company has established robust GMP-compliant facilities (Good Manufacturing Practices) catering to global markets, and its API quality standards meet stringent regulatory frameworks such as USFDA and EMA. -
Lupin Limited
Also based in India, Lupin produces irbesartan API and supplies it to both domestic generic markets and international pharmaceutical companies. Lupin’s manufacturing plants are certified by multiple regulatory agencies, ensuring high-quality API production. -
Mitsubishi Tanabe Pharma Corporation
A Japanese pharmaceutical leader engaged in biotech and chemical manufacturing, Mitsubishi has historically supplied high-quality IRB API for both proprietary formulations and licensing partnerships. -
Aurobindo Pharma
One of India’s prominent pharma manufacturers with significant API production capacity. Aurobindo segments its API manufacturing under strict regulatory oversight, with exports spanning North America, Europe, and Asia.
2. Contract Manufacturing Organizations (CMOs)
- Several large CMOs serve as third-party suppliers for irbesartan API, fulfilling demand for generic formulations globally. These include Cipla BioTec, Hikma Pharmaceuticals, and Sun Pharmaceutical Industries. Contract manufacturing on this scale provides flexibility for drug producers to diversify supply sources and mitigate risk.
Formulation Manufacturers and Generic Suppliers
Once the API is produced, the formulation of AVAPRO tablets involves additional manufacturing units, often subcontracted or integrated within the supply chain.
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Teva Pharmaceutical Industries
A leading global generic drug manufacturer, Teva has historically supplied AVAPRO formulations in multiple markets, leveraging consistent API sourcing and robust manufacturing infrastructure. -
Mylan (now part of Viatris)
Mylan produces generic irbesartan tablets supplied to many countries, often competing on pricing and market penetration. -
Sandoz (Novartis division)
Sandoz’s generic portfolio includes AVAPRO, with manufacturing facilities compliant with global regulatory standards.
Supply Chain Dynamics and Regulatory Considerations
1. Regulatory Approvals and Certifications
API and formulation suppliers must comply with regulations such as the USFDA, EMA, Japan PMDA, and WHO prequalification standards. This ensures the API’s purity, consistency, and safety essential for maintaining supply chain integrity.
2. Geographical Distribution of Suppliers
India and China dominate API manufacturing, providing cost advantages and manufacturing scale. However, geopolitical shifts, export restrictions, or regulatory audits can impact supply continuity. Diversification across regions is a strategic priority for pharmaceutical companies sourcing AVAPRO.
3. Active Market Competition and Patent Status
Since the original patent for irbesartan expired, numerous generic manufacturers have entered the market, increasing supply options but also leading to commoditization and pricing pressures. Key patent expirations occurred in 2019 in several jurisdictions, expanding supplier pools globally.
Market and Supplier Challenges
- Supply Disruptions: Natural disasters, geopolitical tensions, or regulatory breaches at API plants can cause supply shortages. The COVID-19 pandemic highlighted vulnerabilities in complex supply chains.
- Quality Variability: Ensuring consistent quality remains central, demanding rigorous supplier qualification and batch testing.
- Cost Pressures: Competition among low-cost API producers pressures margins, influencing supplier selection strategies.
Emerging Trends and Future Outlook
- Localized Manufacturing: Governments incentivize domestic API production to reduce reliance on imports, potentially altering the current supplier landscape.
- Sustainable Manufacturing: Increasing emphasis on environmentally sustainable processes may impact supplier operations.
- Regulatory Harmonization: Updates in international standards and increasing data transparency could streamline supplier qualification but also introduce compliance complexities.
Key Takeaways
- The global supply of AVAPRO relies predominantly on API manufacturers in India and China, with key suppliers including Hetero Labs, Lupin, Aurobindo, and Mitsubishi Tanabe.
- Regulatory certification (USFDA, EMA) is critical for supplier legitimacy and supply security.
- The generic market for irbesartan has expanded significantly post-patent expiration, offering multiple sourcing options, but also increasing market competition.
- Supply chain resilience requires diversification, continuous quality oversight, and adherence to evolving regulatory standards.
- Strategic partnerships with reliable API manufacturers are essential for pharmaceutical companies to ensure uninterrupted AVAPRO availability.
Frequently Asked Questions
Q1: Who are the primary API manufacturers for AVAPRO?
A: Hetero Labs, Lupin, Aurobindo, and Mitsubishi Tanabe Pharma are among the leading API producers for irbesartan used in AVAPRO formulations.
Q2: Are there regional differences in AVAPRO supplier options?
A: Yes. India and China dominate API production, but regulatory standards and geopolitical factors influence supplier reliability across regions.
Q3: How does patent expiration impact AVAPRO supply?
A: It has increased the number of generic manufacturers, broadening supply sources but intensifying price competition.
Q4: What regulatory standards ensure AVAPRO API quality?
A: Compliance with USFDA, EMA, WHO, and other regional regulatory standards is essential for API suppliers to ensure quality and market access.
Q5: What risks threaten the continuity of AVAPRO supply?
A: Disruptions may arise from manufacturing issues, regulatory non-compliance, geopolitical tensions, or global crises like pandemics.
References
- [1] U.S. Food & Drug Administration (FDA). “API Suppliers List,” FDA Database.
- [2] Indian Pharmaceutical Alliance. “Top API Manufacturers in India,” 2022.
- [3] European Medicines Agency (EMA). “Manufacturers and Approval Status,” EMA Public Inspection Reports.
- [4] IMS Health. Global Pharmaceutical Market Analysis, 2022.
- [5] Patent Expiry Information, FDA Orange Book, 2019.
Conclusion
The supply landscape for AVAPRO hinges on a combination of established API producers in India and Japan, with diversified formulation manufacturers. Ensuring consistency, quality, and regulatory compliance remains essential in maintaining supply chain resilience. Stakeholders must continuously monitor geopolitical, regulatory, and market developments to adapt their sourcing strategies accordingly.
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