Suppliers and packagers for captopril

captopril

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	CAPTOPRIL	captopril	TABLET;ORAL	212809	ANDA	Major Pharmaceuticals	0904-7105-61	100 BLISTER PACK in 1 CARTON (0904-7105-61) / 1 TABLET in 1 BLISTER PACK	2019-12-13
Ajanta Pharma Ltd	CAPTOPRIL	captopril	TABLET;ORAL	212809	ANDA	Major Pharmaceuticals	0904-7106-61	100 BLISTER PACK in 1 CARTON (0904-7106-61) / 1 TABLET in 1 BLISTER PACK	2019-12-13
Ajanta Pharma Ltd	CAPTOPRIL	captopril	TABLET;ORAL	212809	ANDA	Ajanta Pharma USA Inc.	27241-160-01	100 TABLET in 1 BOTTLE (27241-160-01)	2019-12-13

Suppliers for the Pharmaceutical Drug: CAPTOPRIL

Last updated: July 29, 2025

Introduction
Captopril is an angiotensin-converting enzyme (ACE) inhibitor primarily used to treat hypertension and congestive heart failure. Since its discovery and approval, global demand has propelled a complex supply chain involving multiple manufacturers and suppliers. Understanding the landscape of captopril suppliers is essential for pharmaceutical stakeholders, healthcare providers, and procurement strategists aiming to ensure supply stability, compliance, and competitive pricing.

Overview of Captopril Manufacturing
Captopril was first introduced in the 1980s by Sangstat (later acquired by Pfizer) and is now produced by numerous pharmaceutical companies worldwide. Its synthesis involves intricate organic chemistry processes, typically requiring high-quality raw materials and stringent manufacturing standards. The global supply chain includes active pharmaceutical ingredient (API) producers, finished drug manufacturers, and distributors.

Key API Suppliers of Captopril

1. Traditionally Established API Manufacturers
   Several companies have historically dominated the captopril API market, primarily in regions with advanced pharmaceutical manufacturing infrastructure, like India, China, and Europe. These companies are recognized for compliance with Good Manufacturing Practices (GMP), quality assurance, and supply capacity.

   • Hetero Labs Ltd. (India): One of the leading API producers globally, Hetero supplies pharmaceutical APIs across multiple therapeutic classes, including captopril. Their manufacturing facilities meet international quality standards, supporting global export [1].

   • Aurobindo Pharma Ltd. (India): Known for cost-effective API manufacturing, Aurobindo produces captopril as part of its extensive portfolio for cardiovascular drugs. Their facilities are GMP-certified, supporting large-scale exports [2].

   • Zhejiang Hisoar Pharmaceutical Co., Ltd. (China): A notable API manufacturer specializing in antihypertensive compounds, including captopril. The company adheres to international quality standards, catering to domestic and export markets [3].

   • Lunan Pharmaceutical Group (China): This manufacturer has expanded into the API sector with multiple antihypertensive APIs, including captopril, supported by robust R&D capabilities [4].

2. Emerging and Contract Manufacturers
   Contract manufacturing organizations (CMOs) and emerging API producers have increased their presence, especially in response to rising global demand and supply chain diversifications.

   • HUBEI YIFENG PHARMACEUTICAL CO., Ltd. (China): They manufacture pharmaceutical intermediates and APIs, including captopril, leveraging efficient production methods [5].

   • Hikma Pharmaceuticals (Jordan): Occasionally acts as a CMO for APIs, including ACE inhibitors, contributing to diversified supply sources [6].

Raw Material and Synthesis Raw Materials
The key raw materials for captopril synthesis include captopril’s precursor compounds, such as propiolamide and other amino acid derivatives. Their sources are often diversified across chemical suppliers globally, with major chemical companies providing these intermediates.

Distribution and Logistics
Once produced, API suppliers distribute their products through global logistics networks. Many suppliers adhere to serialization and traceability standards required by regulators like the U.S. FDA and EMA, ensuring supply chain integrity.

Market Players and Competitive Landscape

• India’s Prominent Role: India hosts many API and finished drug manufacturers, holding a significant share of the global captopril supply. Companies like Hetero, Aurobindo, and Sun Pharma dominate due to their scale, cost advantages, and compliance credentials [7].

• Chinese Industry: China has rapidly expanded its API manufacturing capacity, with Zhejiang Huahai, Zhejiang Hisoar, and others contributing critically to the global supply chain.

• European and North American Providers: While smaller in volume, these suppliers emphasize stringent quality standards, serving high-end markets and regulatory-compliant exports.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Suppliers must adhere to GMP standards aligned with the requirements of agencies such as the FDA, EMA, and WHO. Non-compliance can lead to supply disruptions or market restrictions [8].

• Quality and Consistency: The complexity of synthesis requires continuous quality assurance to prevent batch failures and ensure therapeutic efficacy.

• Geopolitical Risks: Trade tensions and export bans, particularly in China and India, can cause fluctuations in supply availability.

• Pricing Dynamics: Competition among low-cost producers in Asia maintains competitive pricing but also pressures profit margins and investment in quality controls.

Future Trends and Market Outlook

• Shift toward Diversification: Companies are increasingly diversifying sources to mitigate risks associated with over-dependence on a few suppliers or regions.

• Biotech Integration: Advances in synthetic methods and bioengineering could influence future API manufacturing pathways for ACE inhibitors, including captopril.

• Regulatory Harmonization: Ongoing efforts aim to streamline approval processes and quality standards internationally, easing market entry for new suppliers.

Conclusion
The global supply landscape for captopril involves a diverse range of manufacturers, predominantly located in India and China, with key players investing in quality and capacity expansion. Supply chain resilience depends on regulatory compliance, raw material sourcing, geopolitical stability, and technological innovation. Stakeholders must maintain strategic supplier relationships and monitor global regulatory developments to ensure uninterrupted access to this critical antihypertensive medication.

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Key Takeaways

• Major API producers include Hetero Labs, Aurobindo Pharma, Zhejiang Hisoar, and Lunan Pharmaceutical, primarily based in India and China.
• Supply chain reliability hinges on compliance with GMP standards and diversification of sourcing to mitigate geopolitical and regulatory risks.
• Raw material quality and certification significantly impact the production capacity and stability of captopril supply.
• Emerging contractors and regional manufacturers are increasing their market share, contributing to industry resilience.
• Regulatory environments influence manufacturing practices, export potential, and market access for API suppliers.

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FAQs

1. Who are the main API suppliers for captopril globally?
The leading global suppliers include Indian companies such as Hetero Labs and Aurobindo Pharma, as well as Chinese manufacturers like Zhejiang Hisoar and Lunan Pharmaceutical. They are recognized for their compliance with international GMP standards and large-scale production capabilities.

2. How does geopolitical stability affect captopril supply?
Geopolitical tensions, export restrictions, and trade disputes, particularly involving China and India, can disrupt or delay API shipments, impacting the availability of captopril in global markets.

3. What are the key challenges faced by captopril API suppliers?
Major challenges include ensuring GMP compliance, maintaining high-quality standards amidst complex chemical synthesis, raw material sourcing, and adapting to evolving regulatory requirements.

4. Are there emerging regions or companies developing new sources of captopril?
Yes, other Asian countries and regional CMOs are investing in manufacturing capacity and quality systems, offering increased diversification and resilience in the supply chain.

5. What role do regulatory agencies play in the supply of captopril?
Regulatory agencies enforce GMP standards, oversee quality controls, and approve manufacturing facilities and products, directly influencing the capacity, quality, and exportability of captopril APIs.

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References

[1] Indian API Manufacturers Association, "Major Pharmaceutical API Suppliers in India," 2022.
[2] Aurobindo Pharma Annual Report, 2022.
[3] Zhejiang Hisoar Pharmaceutical Co., Ltd. Product Catalog, 2023.
[4] Lunan Pharmaceutical Group Official Website, 2023.
[5] HUBEI YIFENG PHARMACEUTICAL CO., Ltd. Production Overview, 2022.
[6] Hikma Pharmaceuticals CMO Portfolio Report, 2022.
[7] IMS Health, "Global API Market Analysis," 2022.
[8] WHO GMP Guidelines for Active Pharmaceutical Ingredients, 2022.