BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE pharmaceutical API fine chemical suppliers

Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical	⤷ Get Started Free	2023-05-7C02512	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: August 8, 2025

Introduction

Benazepril Hydrochloride and Hydrochlorothiazide are two widely prescribed medications used in combination therapy for hypertension and congestive heart failure management. The pharmaceutical industry relies heavily on the sourcing of high-quality APIs from global suppliers. This article provides a comprehensive overview of the key manufacturing sources, regulatory landscape, and market trends for these APIs, offering essential insights for stakeholders involved in procurement, manufacturing, and strategic planning.

Overview of Benazepril Hydrochloride and Hydrochlorothiazide

Benazepril Hydrochloride is an angiotensin-converting enzyme (ACE) inhibitor that reduces blood pressure and improves survival in heart failure by inhibiting the renin-angiotensin-aldosterone system. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that promotes diuresis, thereby reducing plasma volume and lowering blood pressure.

The combination of these APIs offers synergistic effects in antihypertensive therapy, making their reliable sourcing critical for generic and branded formulations globally.

Global API Manufacturing Landscape

Key Regions and Countries

The primary regions producing bulk APIs for Benazepril Hydrochloride and Hydrochlorothiazide are:

India: Dominates as the largest API producer due to cost advantages, extensive manufacturing capacity, and a robust regulatory framework.
China: Maintains a strong position driven by high-volume manufacturing, innovative capabilities, and competitive pricing.
Europe and the United States: Focus more on high-value, highly compliant suppliers for specialized or regulated markets, although local manufacturing is limited compared to India and China.
Others: Countries like Korea and some Southeast Asian nations participate in niche or specialty API production.

Major API Manufacturers

India

India hosts several leading API manufacturers with proven track records in quality compliance and regulatory approvals:

Sun Pharmaceutical Industries Ltd.: Produces a wide array of APIs, including hydrochlorothiazide, and supplies to global markets.
Aurobindo Pharma: Offers bulk APIs for antihypertensive drugs, adhering to stringent GMP standards.
Lupin Limited: Known for robust API manufacturing in cardiovascular segments.
Micro Labs: Specializes in both Benazepril and Hydrochlorothiazide APIs.
Biological E. Limited: Focuses on generic APIs, including ACE inhibitors.

China

Chinese manufacturers supply a significant portion of the global API demand, with facilities accredited by US FDA, EU EMA, and other regulatory bodies:

Shanghai Huangxin Pharmaceutical Co., Ltd.: Produces hydrochlorothiazide with high compliance standards.
Qilu Pharmaceutical: Offers high-quality Benazepril APIs for export.
Hengdian Group DME Medical | Hengdian: Supplies sensitive APIs, including ACE inhibitors, with GMP certifications.
North China Pharmaceutical Group Corporation (NCPC): Extensive portfolio in cardiovascular APIs.

Europe and North America

While less dominant in bulk API manufacturing, certain companies excel in producing high-purity APIs under strict regulatory standards:

Sandoz (Novartis): Occasional supplier in regulated markets.
Cambrex Corporation: Focuses on advanced API manufacturing in North America.
Bachem AG: Provides custom synthesis and high-quality APIs.

Regulatory Environment and Quality Standards

Manufacturers for Benazepril Hydrochloride and Hydrochlorothiazide must comply with Good Manufacturing Practices (GMP), which are enforced by regulators such as the FDA and EMA. Suppliers are often audited and certified for compliance, ensuring product quality, traceability, and stability.

In addition, for APIs destined for specific markets, suppliers must secure appropriate certifications, including:

Drug Master File (DMF) filings with regulatory bodies
Active Substance Master File (ASMF) approval in Europe
ISO certifications

The increasing focus on supply chain integrity and regulatory compliance favors reputable manufacturers with documented quality assurance programs.

Supply Chain Dynamics and Challenges

Supply Chain Security

API sourcing from India and China remains attractive due to cost advantages; however, geopolitical tensions, trade policies, and the COVID-19 pandemic have heightened concerns over supply chain disruptions. Diversification strategies, including qualifying multiple suppliers, are increasingly adopted.

Price Volatility

Prices for APIs, including Benazepril and Hydrochlorothiazide, fluctuate based on raw material availability, regulatory changes, and manufacturing capacity constraints. Cost-effective production is primarily achievable in India and China.

Environmental and Regulatory Concerns

Environmental regulations regarding solvent use, waste management, and emissions impact manufacturing continuity. Suppliers investing in sustainable practices gain competitive advantages.

Market Trends and Future Outlook

Growing Demand in Emerging Markets: Increased hypertension prevalence in Asia and Africa boosts demand for affordable APIs.
Regulatory Harmonization: Stricter quality standards foster a preference for suppliers with robust compliance.
Manufacturing Innovation: Adoption of continuous manufacturing and green chemistry enhances efficiency and sustainability.
Supply Chain Diversification: Companies mitigate risks by qualifying multiple suppliers across regions.
Patent Expiry and Generic Competition: Facilitates entry for generic API manufacturers, amplifying supply sources.

Conclusion

The sourcing of bulk APIs for Benazepril Hydrochloride and Hydrochlorothiazide is predominantly centered around India and China, which offer extensive manufacturing capacity, competitive pricing, and evolving quality standards. Ensuring supply security requires engagement with reputable suppliers possessing robust regulatory compliance and quality assurance processes. As global demand persists and regulatory landscapes tighten, manufacturers and buyers should prioritize diversification, sustainability, and technological innovation in API sourcing strategies.

Key Takeaways

India and China dominate in manufacturing Benazepril Hydrochloride and Hydrochlorothiazide APIs, offering affordability and capacity.
Regulatory compliance (GMP, DMF, ASMF) is critical; partnering with certified suppliers minimizes compliance risks.
Supply chain resilience is vital due to geopolitical and pandemic-related disruptions; diversification reduces dependency.
Innovation and sustainability are increasingly influencing supplier selection, with green manufacturing practices gaining importance.
Market growth in emerging economies promises sustained demand, reinforcing the importance of reliable API sources.

FAQs

What are the primary challenges in sourcing Benazepril Hydrochloride and Hydrochlorothiazide APIs?
Supply chain disruptions, regulatory compliance, price volatility, and environmental regulations are key challenges, especially with reliance on Chinese and Indian manufacturers.
How can pharmaceutical companies ensure API quality when sourcing from overseas suppliers?
By conducting rigorous audits, verifying GMP accreditation, reviewing regulatory filings, and establishing long-term partnerships with certified suppliers.
Are there any new entrants or emerging regions in the API manufacturing landscape?
Yes, Southeast Asian countries and South America are gradually expanding their presence, although their offerings are less established compared to India and China.
What regulatory considerations should buyers keep in mind when sourcing these APIs?
Ensuring suppliers possess valid DMFs or ASMFs, GMP certification, and compliance with regional regulations such as FDA or EMA standards.
How is market demand for these APIs expected to evolve in the next five years?
Demand is expected to grow, driven by increasing prevalence of hypertension globally and expanding healthcare access in emerging markets, requiring a resilient and well-regulated supply chain.

Sources

[1] IQVIA. Global API Market Reports, 2022.
[2] US FDA Drug Master Files and API approvals, 2023.
[3] Industry Analyses on API Manufacturing, 2023.
[4] Research on Supply Chain Risks, WHO and industry reports.
[5] Market trends in antihypertensive drugs, Global Data, 2022.

Bulk Pharmaceutical API Sources for BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE