Bulk Pharmaceutical API Sources for PERINDOPRIL ERBUMINE

Bulk Pharmaceutical API Sources for PERINDOPRIL ERBUMINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-611
Hangzhou APIChem Technology		AC-19078
Amadis Chemical		A801591
AKos Consulting & Solutions		AKOS015841351
AKos Consulting & Solutions		AKOS015961912
Finetech Industry Limited		FT-0631042
Key Organics/BIONET		KS-1243

Bulk Active Pharmaceutical Ingredient (API) Sources for: Perindopril Erbumine

Last updated: August 1, 2025

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Introduction

Perindopril erbumine, an angiotensin-converting enzyme (ACE) inhibitor, plays a critical role in managing hypertension and heart failure. As a vital component in many cardiovascular treatment regimens, its consistent supply from reliable API manufacturers is crucial for pharmaceutical companies and healthcare providers. This article explores the leading sources of bulk perindopril erbumine, analyzing their manufacturing capabilities, regulatory compliance, quality standards, and global distribution networks.

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Overview of Perindopril Erbumine and API Market Dynamics

Perindopril erbumine is a prodrug that, post-administration, converts to perindoprilat, exerting antihypertensive effects. Its market demand is driven by the prevalence of hypertension globally and the continued need for effective ACE inhibitors. The API market for perindopril erbumine is concentrated among manufacturers capable of meeting stringent quality and regulatory standards, including Good Manufacturing Practice (GMP) compliance, especially for markets like the U.S. (FDA), Europe (EMA), and Japan (PMDA).

The supply chain for perindopril erbumine API is characterized by a limited number of specialized chemical producers, often based in Asia and Europe, who possess the capacity to produce API at clinical and commercial scales. Quality assurance, consistent purity, and regulatory approval are non-negotiable criteria in selecting sources.

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Major API Manufacturers for Perindopril Erbumine

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Profile:
Zhejiang Huahai is among the world’s leading API producers, with extensive experience manufacturing cardiovascular APIs, including ACE inhibitors. The company has a robust R&D network, advanced synthesis capabilities, and GMP-certified facilities.

Capabilities:

• Produces bulk perindopril erbumine at gram to metric ton scale.
• Consistently meets international quality standards.
• Holds multiple regulatory approvals, with a focus on the European and Asian markets.

Regulatory Status:

• Complies with EU GMP standards and has been inspected by the EMA.
• Recognized by numerous regulatory agencies for clean production records.

Distribution:
Exports globally, with a strong presence in North America, Europe, and Asia.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Profile:
Hengrui is a leading innovator and manufacturer of cardiovascular APIs, including ACE inhibitors. The company offers high-quality perindopril erbumine API, supported by rigorous quality control and compliance with international standards.

Capabilities:

• Large-scale manufacturing capacities.
• Integrated R&D for process optimization and impurity control.
• Focus on sustainable manufacturing practices.

Regulatory Status:

• GMP certification aligned with local and international regulatory agencies (FDA, EMA).
• Active registration efforts in key markets, facilitating global distribution.

Distribution:
Global reach, with a focus on the Asia-Pacific region, Europe, and emerging markets.

3. Zhejiang Singclean Pharmaceutical Co., Ltd. (China)

Profile:
Specialized in cardiovascular APIs, Singclean has established a reputation for producing high-purity ACE inhibitors. Their manufacturing plants are GMP-certified, and the company emphasizes quality assurance.

Capabilities:

• Produces bulk perindopril erbumine batches suitable for both generic and branded formulations.
• Capable of supplying custom synthesis and contract manufacturing.

Regulatory Status:

• GMP certification for export markets.
• Participation in health authority inspections (e.g., China’s NMPA).

Distribution:
Supplies primarily within Asia and through strategic partnerships globally.

4. Teva Pharmaceutical Industries Ltd. (Israel)

Profile:
Although primarily known as a finished dosage form provider, Teva maintains a significant API manufacturing segment for cardiovascular drugs, including ACE inhibitors.

Capabilities:

• Global manufacturing sites with strict GMP adherence.
• Experience supplying APIs to global generic markets.

Regulatory Status:

• Compliant with FDA, EMA, and other international standards.
• Regular inspections and validation reports available.

Distribution:
Worldwide, with established supply chains to North America, Europe, and Latin America.

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Emerging and Contract Manufacturing Sources

5. Laurus Labs (India)

Overview:
Laurus Labs has expanded its portfolio by including ACE inhibitors, with capacities for large-scale API production.

Strengths:

• Cost-effective manufacturing, competitive pricing.
• GMP-certified facilities, with an increasing focus on quality and regulatory compliance.
• Strategic partnerships for global distribution.

6. Sandoz (Novartis Division, Switzerland/India)

Overview:
Sandoz, a pioneer in generic APIs, supplies high-quality ACE inhibitor APIs, including perindopril erbumine, via their global manufacturing network.

Strengths:

• Proven track record of regulatory compliance.
• Capable of meeting large orders and customizing supply according to client needs.

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Regulatory and Quality Considerations

Manufacturers must adhere to strict standards, including GMP compliance and stringent impurity testing. Regulatory approvals facilitate market access and ensure API quality, impacting drug stability, safety, and efficacy. The FDA, EMA, and other agencies routinely audit API manufacturers and require comprehensive documentation, including Certificates of Analysis (CoA), stability data, and batch records.

In recent years, GMP violations and quality lapses in Chinese API producers have prompted stricter scrutiny, emphasizing the importance of verified, audited suppliers for quality assurance.

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Geographic Distribution and Market Trends

While China remains the dominant source for bulk perindopril erbumine, overwhelmingly due to cost efficiencies, India is increasingly emerging as a competitive alternative, offering comparable quality at lower costs. European and North American manufacturers primarily serve niche markets or utilize their API manufacturing capabilities for specialized formulations.

An evolving trend emphasizes stringent regulatory oversight and tiered supplier qualification processes, ensuring pharmaceutical companies mitigate supply chain risks associated with API sourcing.

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Supply Chain Risks and Mitigation

• Regulatory compliance gaps lead to product recalls or market access barriers.
• Overdependence on a single geographic region increases vulnerability to geopolitical or supply disruptions.
• Quality inconsistencies threaten patient safety and regulatory approval.

Proactive sourcing strategies involve multiple certified suppliers, rigorous audits, and supply chain diversification.

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Key Considerations for Selecting API Suppliers

• Regulatory compliance (GMP certification/inspection history)
• Manufacturing capacity for current and projected demand
• Quality assurance procedures and impurity profiles
• Pricing and lead times
• Logistics and distribution capabilities
• Supplier reputation and track record

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Key Takeaways

• The bulk API supply for perindopril erbumine is predominantly driven by manufacturers in China and India, with established European players providing compliant, high-quality products.
• Regulatory compliance and GMP standards are essential for ongoing supply stability, especially in tightly regulated markets like the U.S. and Europe.
• The market trend favors diversified supply chains to mitigate risks associated with geopolitical tensions and quality lapses.
• Strategic partnerships and thorough supplier audits are critical to securing a reliable supply of high-quality API.
• Patent and regulatory landscapes should be continuously monitored to adapt sourcing strategies in response to evolving global standards.

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FAQs

1. What are the leading manufacturing countries for perindopril erbumine API?
   China and India are the primary sources, with European companies playing a significant role in high-quality, regulated markets.

2. What regulatory standards should API manufacturers meet for global supply?
   GMP compliance (FDA, EMA, NMPA), batch consistency, impurity profiles, and proper documentation are essential.

3. Can I rely solely on Chinese API suppliers for perindopril erbumine?
   While many are capable, diversification and supplier qualification are advisable to reduce risks related to quality and regulatory scrutiny.

4. How do regulatory inspections impact API suppliers?
   Successful inspections by agencies like the FDA and EMA validate GMP compliance, essential for global market access and supply continuity.

5. Are there reliable alternative sources for perindopril erbumine APIs?
   Yes. Indian manufacturers such as Laurus Labs and established European suppliers provide competitive alternatives, supported by strong regulatory compliance.

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References

1. [1] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice for Active Pharmaceutical Ingredients." 2017.
2. [2] U.S. Food and Drug Administration (FDA). "Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals." 21 CFR Part 211.
3. [3] Zhejiang Huahai Pharmaceutical Co., Ltd. Corporate Website.
4. [4] Jiangsu Hengrui Medicine Co., Ltd. Corporate Profile.
5. [5] Sanjay, B. et al. "Manufacturing Trends and Quality Standards for API Production," International Journal of Pharmaceutical Sciences. 2022.

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Conclusion

Securing high-quality bulk perindopril erbumine API hinges on selecting experienced, compliant manufacturers that meet global quality standards. Informed sourcing, diversified supply chains, and ongoing regulatory vigilance are vital to ensuring uninterrupted supply and maintaining product integrity in the competitive pharmaceutical landscape.