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Suppliers and packagers for generic pharmaceutical drug: perindopril erbumine
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perindopril erbumine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | PERINDOPRIL ERBUMINE | perindopril erbumine | TABLET;ORAL | 079070 | ANDA | Aurobindo Pharma Limited | 65862-286-01 | 100 TABLET in 1 BOTTLE (65862-286-01) | 2009-11-10 |
| Aurobindo Pharma | PERINDOPRIL ERBUMINE | perindopril erbumine | TABLET;ORAL | 079070 | ANDA | Aurobindo Pharma Limited | 65862-287-01 | 100 TABLET in 1 BOTTLE (65862-287-01) | 2009-11-10 |
| Aurobindo Pharma | PERINDOPRIL ERBUMINE | perindopril erbumine | TABLET;ORAL | 079070 | ANDA | Aurobindo Pharma Limited | 65862-288-01 | 100 TABLET in 1 BOTTLE (65862-288-01) | 2009-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Perindopril Erbumine
Introduction
Perindopril erbumine is an angiotensin-converting enzyme (ACE) inhibitor widely prescribed for hypertension, heart failure, and preventing cardiovascular events. As a critical medication with substantial demand, understanding the global landscape of its suppliers is vital for stakeholders, including manufacturers, healthcare providers, and investors. This report details key suppliers, manufacturing trends, regulatory considerations, and market dynamics influencing the supply chain for perindopril erbumine.
Overview of Perindopril Erbumine
Perindopril erbumine is a prodrug converted into perindopril active form within the body. Its patent status varies internationally, with generic formulations increasingly prevalent. The drug’s manufacturing involves complex synthetic routes, primarily controlled by pharmaceutical chemical suppliers and active pharmaceutical ingredient (API) manufacturers.
Global API Suppliers for Perindopril Erbumine
Major API Producers
Perindopril erbumine's raw material—perindopril maleate or other salt forms—is primarily produced by specialized chemical companies with expertise in ACE inhibitors.
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CSPC Pharmaceutical Group (China)
CSPC is among the leading manufacturers of APIs, including ACE inhibitors like perindopril. Its vertically integrated supply chain ensures high-volume production at competitive prices, primarily serving Asian and global markets [1]. -
Shandong Taii Pharmaceutical Co. Ltd. (China)
Recognized for manufacturing cardiovascular APIs, Shandong Taii supplies perindopril in bulk form to generic drug manufacturers worldwide. Their facilities are GMP-certified, ensuring compliance with international standards [2]. -
Mingyuan Pharmatech (China)
This firm specializes in APIs for cardiovascular drugs, including perindopril. They focus on high-quality synthesis and infrastructure that meets stringent regulatory requirements [3]. -
Dr. Reddy's Laboratories (India)
Dr. Reddy’s produces a range of cardiovascular APIs, including perindopril. Its global footprint and reputation for quality make it a trusted source for licensed and generic formulations [4]. -
Aurobindo Pharma (India)
Aurobindo’s API division manufactures ACE inhibitors, including perindopril. Their substantial manufacturing capacity and global distribution infrastructure support widespread supply [5]. -
Teva Pharmaceuticals (Israel)
As a prominent generic pharmaceutical company, Teva sources or manufactures perindopril APIs through strategic partnerships, offering high-quality products globally [6].
Environmental and Regulatory Aspects Impacting Suppliers
Manufacturers must adhere to Good Manufacturing Practices (GMP), ISO standards, and local regulatory frameworks, notably those of the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulators.
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Quality Control & Certification: Suppliers like CSPC, Dr. Reddy’s, and Aurobindo maintain rigorous quality measures, including batch testing, stability studies, and compliance with pharmacopoeial standards (e.g., USP, EP).
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Regulatory Approvals: Suppliers’ API batches generally need approval for specific markets. Variations in regulatory requirements influence supplier choice, especially in stringent jurisdictions like the EU or US.
Market Dynamics & Trends
Generic Market and Cost Drivers
The expiration of patents in multiple regions has shifted supply towards generic API manufacturing. Price competition among Asian suppliers has led to more affordable options, increasing accessibility, especially in emerging markets.
Supply Chain Challenges
Recent disruptions, such as trade tensions, COVID-19 impacts, and raw material shortages, have highlighted vulnerabilities in the API supply chain. These challenges prompt buyers to diversify suppliers and increase stockpiling strategies.
Emerging Suppliers and R&D Investment
Growing investment by Chinese and Indian firms in API R&D aims to enhance process efficiency and environmental sustainability. Some companies are exploring biosynthetic or greener synthesis routes to reduce ecological impact, aligning with global regulatory trends.
Distribution and Contract Manufacturing
API large-scale manufacturing often involves contract manufacturing organizations (CMOs). Notably:
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Hikma Pharmaceuticals (Middle East)
Offers contract manufacturing of ACE inhibitors, including perindopril, supporting global supply continuity. -
Alphapharm (Greece)
Engages in contract production for European clients. -
Other Regional Suppliers
Numerous regional or national companies produce perindopril APIs for local markets, emphasizing the importance of regional regulatory knowledge and logistics.
Conclusion
The landscape of suppliers for perindopril erbumine is predominantly centered in Asia, with China and India hosting leading producers like CSPC, Shandong Taii, Dr. Reddy’s, and Aurobindo. These companies benefit from high-capacity manufacturing, cost advantages, and expanding R&D investments. Regulatory compliance and quality assurance remain critical factors influencing supplier selection. The globalization of supply sources mitigates risks but also underscores the importance of strategic diversification amid ongoing supply chain challenges.
Key Takeaways
- The majority of perindopril erbumine APIs are produced by Chinese and Indian manufacturers, with companies like CSPC, Dr. Reddy’s, and Aurobindo leading the market.
- Regulatory compliance and quality assurance are non-negotiable factors in the selection of API suppliers, strongly influencing global procurement strategies.
- The market is evolving with increased emphasis on sustainable and greener manufacturing processes, driven by regulatory and environmental considerations.
- Supply chain disruptions heighten the importance of diversified sourcing and strategic inventory management.
- Contract manufacturing organizations play a vital role in augmenting supply capacity, especially during global crises or surges in demand.
FAQs
1. Who are the top global suppliers of perindopril erbumine API?
The leading suppliers are CSPC Pharmaceutical Group (China), Dr. Reddy’s Laboratories (India), Aurobindo Pharma (India), and Shandong Taii Pharmaceutical (China), among others.
2. How do regulatory standards affect API suppliers?
Suppliers must comply with GMP, ISO standards, and specific country regulations (e.g., FDA, EMA). Non-compliance can delay approvals and impact supply continuity.
3. Are there regional variations in perindopril erbumine supply?
Yes. While Asian suppliers dominate global markets, regional suppliers in Europe, North America, and Latin America provide localized sourcing options, often emphasizing regulatory conformity and shorter supply chains.
4. What are the recent trends influencing API supply for perindopril?
Key trends include increased manufacturing capacity, R&D investments in eco-friendly synthesis, diversification of supply sources, and adaptation to regulatory requirements.
5. How might supply chain disruptions impact the availability of perindopril erbumine?
Disruptions could lead to shortages, increased prices, or delays, highlighting the importance of supply diversification, inventory safeguards, and strategic partnerships.
References
[1] CSPC Pharmaceutical Group Annual Report, 2022.
[2] Shandong Taii Pharmaceutical Co. Ltd. GMP Certification, 2022.
[3] Mingyuan Pharmatech Capabilities Overview, 2022.
[4] Dr. Reddy's Laboratories API Portfolio, 2022.
[5] Aurobindo Pharma API manufacturing Data, 2022.
[6] Teva Pharmaceuticals Global API Supplier Index, 2022.
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