SERPASIL-APRESOLINE bulk active 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	2023-05-19B2851	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: July 29, 2025

Introduction

Serpasil, with the generic name Hydralazine hydrochloride, is a well-established antihypertensive agent used primarily in the management of moderate to severe hypertension and hypertensive crises. As a critical component in pharmaceutical manufacturing, the procurement of high-quality bulk Active Pharmaceutical Ingredient (API) is essential for ensuring medication efficacy, safety, and regulatory compliance.

This article evaluates the key sources for pure hydralazine hydrochloride APIs, highlighting supplier reputations, manufacturing standards, geographic distribution, and implications for pharmaceutical companies seeking reliable API supply chains for Serpasil production.

Global API Manufacturing Landscape for Hydralazine Hydrochloride

Hydralazine hydrochloride, the API in Serpasil, is produced predominantly in regions with advanced pharmaceutical manufacturing capabilities, notably in India, China, Europe, and the United States. The API supply chain's robustness, compliance with Good Manufacturing Practices (GMP), and quality assurance are critical factors influencing procurement decisions.

Key API Suppliers for Hydralazine Hydrochloride

1. Indian Pharmaceutical Manufacturers

a. Mylan (now part of Viatris Inc.)

Mylan is a leading Indian API producer with GMP-certified facilities manufacturing hydralazine hydrochloride.
Known for stringent quality controls conforming to US FDA, EMA, and WHO standards.
Supplies both domestic Indian markets and exports globally, including to North America and Europe.

b. Aurobindo Pharma

A prominent Indian API manufacturer with a comprehensive portfolio including hydralazine hydrochloride.
Certified by multiple regulatory bodies, ensuring adherence to international standards.
Offers competitive pricing suitable for large-scale production needs.

c. Hetero Labs

Specializes in cardiovascular APIs, with Hydralazine hydrochloride included in their portfolio.
Emphasizes quality management systems aligned with GMP and USFDA guidelines.
Focuses on markets across Asia, Africa, and Latin America with export capabilities.

2. Chinese Manufacturers

a. Zhejiang Est tires Pharmaceutical Co., Ltd.

An emerging API producer with increasing presence in the global market.
Focuses on affordable APIs with certifiable GMP compliance.
Offers bulk supplies to generic drug manufacturers worldwide.

b. North China Pharmaceutical Group Corporation (NCPC)

Key player with extensive API manufacturing infrastructure.
Emphasizes quality control and regulatory compliance in API production.

3. European and US API Producers

a. Fresenius Kabi

Offers hydralazine hydrochloride APIs with high purity, GMP certification, and adherence to quality standards.
Supplies to branded and generic pharmaceutical companies globally.

b. Sigmapharm Laboratories

US-based API manufacturer specializing in cardiovascular and central nervous system APIs.
Complies with FDA regulations, providing high-purity hydralazine hydrochloride APIs suitable for pharmaceutical applications.

c. Teva Pharmaceutical Industries

As both a manufacturer and distributor, Teva supplies APIs globally, including Hydralazine hydrochloride, with proven compliance to GMP standards.

Quality and Regulatory Considerations

GMP Certification: Essential for pharmaceutical APIs to meet international standards. Suppliers should demonstrate compliance with US FDA, EMA, or equivalent regulators.
Certificate of Analysis (CoA): Buyers must verify CoA details, including assay, residual solvents, heavy metals, microbial limits, and polymorphic forms.
Batch Consistency: Reliable API sources maintain consistency across production batches to reduce variability in finished products.
Environmental and Ethical Standards: Suppliers adhering to environmental regulations and ethical manufacturing practices mitigate risks and ensure supply chain integrity.

Supply Chain Risks and Mitigation Strategies

The global API marketplace faces inherent risks such as geopolitical tensions, regulatory variations, raw material shortages, and quality deviations. Strategies to mitigate these include:

Dual sourcing: Engaging multiple suppliers from different regions to prevent supply disruptions.
Supplier Qualification Audits: Conducting rigorous on-site evaluations and ongoing monitoring.
Long-term Contracts: Securing procurement agreements to stabilize pricing and supply commitments.
Inventory Management: Maintaining buffer stocks aligned with forecasted demand.

Emerging Trends in API Sourcing

API Contract Manufacturing: Increasing reliance on Contract Development and Manufacturing Organizations (CDMOs) that adhere to GMP for scalable, compliant API production.
Quality Innovation: Suppliers adopting advanced analytical techniques such as VR spectroscopy and HPLC ensuring higher purity APIs.
Regulatory Harmonization: Streamlining approval processes for APIs from major regions to facilitate cross-border procurement.

Conclusion

For pharmaceutical companies manufacturing Serpasil (Hydralazine hydrochloride), sourcing a reliable, compliant, and high-quality API is paramount. Leading suppliers reside primarily in India, China, Europe, and the United States, each with distinct advantages regarding cost, quality, and regulatory compliance.

Choosing the right API partner involves thorough qualification processes, continuous supplier oversight, and strategic sourcing to match manufacturing needs with supply stability. Staying abreast of industry developments and regulatory standards ensures uninterrupted access to this vital API, enabling the consistent production of safe and effective antihypertensive medications.

Key Takeaways

The most trusted bulk APIs for Hydralazine hydrochloride are produced by Indian, Chinese, European, and US-based manufacturers with GMP certification.
Indian companies like Mylan, Aurobindo Pharma, and Hetero Labs dominate the supply chain, offering cost-effective, compliant APIs.
Quality assurance, including GMP compliance and rigorous analytical testing, remains critical in vendor selection.
Diversification across multiple suppliers mitigates supply chain risks, especially amid geopolitical and regulatory uncertainties.
Staying informed of industry trends, such as contract manufacturing and quality innovation, will optimize sourcing strategies.

FAQs

1. What are the primary regulatory certifications to look for in API suppliers for Hydralazine hydrochloride?

Suppliers should have current GMP certification from reputable authorities such as the US FDA, EMA, or WHO. These certifications confirm adherence to quality standards necessary for pharmaceutical APIs.

2. How do Indian API manufacturers compare to Chinese suppliers in terms of quality and compliance?

Both regions have suppliers meeting international GMP standards. Indian manufacturers often have a longer track record with stringent regulatory audits, especially those supplying to US and European markets. Chinese suppliers are rapidly expanding their GMP capabilities and certifications.

3. What factors influence the choice between domestic and international API sources?

Factors include cost, supply stability, regulatory compliance, quality standards, lead times, and geopolitical considerations. Companies often balance these factors based on their manufacturing footprints and regulatory requirements.

4. How can pharmaceutical companies ensure the quality of bulk hydralazine hydrochloride APIs?

Conduct thorough vendor qualification including document review, on-site audits, batch testing, and review of laboratory certifications. Establish quality agreements and ongoing supplier audits.

5. What emerging trends could impact API sourcing for hypertension medications like Serpasil?

Increased adoption of contract manufacturing, automation in quality control, regulatory harmonization, and sustainable manufacturing practices are shaping future API sourcing paradigms.

References:

Pharmaceutical Technology. "Global APIs Market Overview," 2022.
U.S. FDA Drugs Database. Approved APIs list for cardiovascular agents.
ICMAD. International Contract Manufacturing & Development Organization reports.
WHO Prequalification. List of certified API manufacturers.
Industry reports on API manufacturing trends.

Bulk Pharmaceutical API Sources for SERPASIL-APRESOLINE