Bulk Pharmaceutical API Sources for PINACIDIL

Bulk Pharmaceutical API Sources for PINACIDIL

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		4826
MP Biomedicals		159808
MolPort		MolPort-003-666-777
AAA Chemistry		AR-1C2481
ABI Chem		AC1L1J1H
AKos Consulting & Solutions		AKOS001637331

Bulk Active Pharmaceutical Ingredient (API) Sources for: Pinacidil

Last updated: July 28, 2025

---

Introduction

Pinacidil is a potent vasodilator used primarily in the management of hypertension and angina pectoris. As a K_ATP channel opener, its pharmacologic activity hinges on its chemical purity and consistent supply chain. Securing reliable sources of bulk active pharmaceutical ingredients (APIs) remains crucial for pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and researchers. This analysis reviews the global landscape, highlighting primary suppliers, manufacturing regions, and key considerations for sourcing pinacidil API.

---

Chemical Profile of Pinacidil

Pinacidil’s molecular formula is C_11H_18N_4O, with a molecular weight of approximately 206.29 g/mol. Its chemical structure features an N-phenylpyridine derivative, which influences its chemical stability and manufacturing processes. The synthesis pathway involves complex multi-step procedures requiring specialized facilities that meet Good Manufacturing Practice (GMP) standards (see [1]).

Ensuring chemical purity, typically above 99%, and compliance with pharmacopeial standards (USP, EP, JP) is mandatory for pharmaceutical applications. This emphasizes the importance of sourcing from qualified suppliers who adhere to stringent quality controls.

---

Global Supplier Landscape for Pinacidil API

1. Established Pharmaceutical Chemical Manufacturers

Several major pharmaceutical chemical manufacturers manufacture and supply pinacidil API, often as part of their portfolio of cardiovascular agents:

• Shanghai Chemsyntech Co., Ltd. (China): Noted for producing high-quality APIs with competitive pricing. Their manufacturing facilities are GMP-certified, and they serve both domestic and international clients ([2]).

• Jinan Haohua Industry Co., Ltd. (China): Specializes in the synthesis of pyridine derivatives, including pinacidil. Their products are GMP-compliant, and they regularly export to North America, Europe, and Asia ([3]).

• Toronto Research Chemicals (Canada): Offers research-grade pinacidil, mainly for pharmacological studies. Their quality standards are high, but their supply may not meet bulk pharmaceutical manufacturing volumes ([4]).

• Thermo Fisher Scientific (USA): Provides a range of active pharmaceutical ingredients, including specialty compounds like pinacidil, primarily targeting research and development stages rather than bulk commercial supply ([5]).

2. Asian Manufacturers with Growing Presence

The bulk of global pinacidil API production occurs within Asia—particularly China and India—due to cost advantages and established chemical manufacturing infrastructure:

• Hetero Labs Limited (India): An integrated pharmaceutical producer offering APIs, including specialized compounds, with ISO and GMP certification. Their capacity aligns with large-scale bulk supply ([6]).

• Indo Pharmachem (India): Engages in custom synthesis and bulk API production, with a portfolio that includes similar pyridine derivatives. Their manufacturing adheres to international standards ([7]).

• Jiangxi Huatai Pharmaceutical Co., Ltd. (China): Serves as a regional supplier of cardiovascular API intermediates and actives. Their production meets both domestic and export standards ([8]).

3. Contract Manufacturing and CMO Partnerships

Contract manufacturing organizations play a pivotal role, offering scalable, customizable synthesis:

• Lonza (Switzerland): Although primarily known for biologics, Lonza’s chemical manufacturing division offers custom synthesis routes suited to specialized APIs like pinacidil under strict GMP conditions ([9]).

• BASF (Germany): Provides custom chemical synthesis services, ensuring supply chain security and adherence to high-quality standards for complex molecules such as pinacidil ([10]).

---

Key Considerations in Sourcing Pinacidil API

Quality and Regulatory Compliance

Secure suppliers with validated GMP manufacturing facilities, robust quality assurance processes, and comprehensive batch documentation. The API must comply with pharmacopeial specifications—USP, EP, or JP—and possess Certificates of Analysis (CoA) confirming purity, residual solvents, heavy metals, and other impurities.

Supply Chain Reliability

Assess the supplier's manufacturing capacity, lead times, and ability to meet demand fluctuations. The recent global supply chain disruptions underscore the importance of diversifying sources and establishing long-term contracts.

Pricing and Economic Factors

Chinese and Indian manufacturers typically offer competitive pricing, but cost must be balanced against quality assurance, regulatory compliance, and logistical stability.

Intellectual Property and Licensing

Pinacidil’s patent landscape has evolved; ensure that sourcing does not infringe on patents where applicable. Many manufacturing processes are now off-patent or licensed accordingly.

---

Emerging Trends and Future Outlook

The pharmaceutical industry’s shift towards advanced chemical synthesis techniques and increased regulation push suppliers to adopt greener, more efficient manufacturing processes. There's a rising emphasis on manufacturers capable of producing high-purity APIs at scale with minimal environmental impact.

Emerging Asian manufacturers continue to expand their capabilities, often backed by foreign investment and technology transfer agreements. Furthermore, pre-qualification under international standards enhances the credibility of API suppliers seeking to penetrate global markets.

---

Conclusion

The global landscape of pinacidil API sourcing is predominantly characterized by Asian manufacturers—especially China and India—offering high-quality, cost-effective products. Leading pharmaceutical chemical suppliers, CMOs, and regional producers provide a broad spectrum of options aligning with regulatory standards and supply chain reliability. Manufacturers should prioritize GMP certification, quality assurance, and legislative compliance when selecting partners.

---

Key Takeaways

• Reliable supply of high-purity pinacidil API primarily derives from Asian manufacturers with established GMP credentials.
• Due diligence on supplier quality control, regulatory adherence, and capacity is essential to mitigate risks.
• Diversification across multiple suppliers ensures stability amid global supply chain uncertainties.
• Engagement with reputable CMOs can offer scalable, compliant manufacturing solutions tailored for pharmaceutical commercialization.
• Continuous monitoring of emerging manufacturing technologies and regulatory standards enhances procurement strategies.

---

FAQs

1. What are the main regions producing pinacidil API?
China and India dominate global pinacidil API manufacturing due to cost advantages and developed chemical industries. Europe and North America supply specialized or research-grade APIs.

2. How to verify the quality of pinacidil API?
Request Certificates of Analysis (CoA), review GMP compliance documentation, and verify batch validation against pharmacopeial standards (USP, EP, JP).

3. Are there patent restrictions on sourcing pinacidil?
Most patents related to pinacidil’s synthesis have expired, but manufacturers should perform due diligence to ensure no new proprietary restrictions or licensing requirements.

4. What factors influence the choice of supplier?
Regulatory compliance, product quality, manufacturing capacity, supply stability, pricing, and the supplier's reputation influence sourcing decisions.

5. Is research-grade pinacidil suitable for pharmaceutical manufacturing?
No. Research-grade APIs are intended for laboratory or experimental purposes. Pharmaceutical-grade APIs must meet strict purity and quality specifications under GMP standards.