Bulk Pharmaceutical API Sources for PITAVASTATIN CALCIUM

Bulk Pharmaceutical API Sources for PITAVASTATIN CALCIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-822-984
Amadis Chemical		A808654
AKos Consulting & Solutions		AKOS015900407
Oakwood Products		091500
Key Organics/BIONET		KS-1220
AvaChem Scientific		147526-32-7
AvaChem Scientific		2266

Bulk Active Pharmaceutical Ingredient (API) Sources for Pitavastatin Calcium

Last updated: July 29, 2025

Introduction

Pitavastatin calcium is a potent, lipid-lowering agent belonging to the statin class of drugs used to manage hyperlipidemia and reduce cardiovascular risk. As a critical ingredient in formulations, the quality, provenance, and supply stability of bulk active pharmaceutical ingredients (APIs) like pitavastatin calcium are vital to pharmaceutical manufacturers, regulatory authorities, and healthcare providers. This article provides an in-depth review of global sources for pitavastatin calcium APIs, focusing on manufacturing regions, key suppliers, and compliance factors essential for procurement and supply chain optimization.

Overview of Pitavastatin Calcium API

Pitavastatin calcium is a synthetic lactone that undergoes metabolic activation to inhibit HMG-CoA reductase, a key enzyme in cholesterol biosynthesis. The API must meet stringent quality standards, including purity, potency, residual solvents, and other pharmacopeial requirements. The manufacturing process involves complex chemical synthesis, typically carried out under strict Good Manufacturing Practice (GMP) conditions to ensure product consistency and safety.

Major Geographic Sources of Pitavastatin Calcium API

1. Japan: The Pioneering Producer

Japan remains the pioneering hub for pitavastatin calcium manufacturing, primarily owing to its origin as the country where the drug was first developed by Kowa Company, Ltd. The company holds key patents and manufacturing expertise. Japanese firms generally manufacture APIs for both domestic use and export, adhering to high GMP standards, thus ensuring premium quality.

Key Japanese Suppliers:

• Kowa Company, Ltd.: The original innovator; supplies APIs for global distribution.
• Shionogi & Co., Ltd.: Engages in manufacturing and distributing pitavastatin calcium, often for Asian markets.
• Teva Japan: Collaborates with domestic firms for API production aligned with international standards.

Strengths:

• Cutting-edge manufacturing technology.
• Consistent compliance with international pharmacopeias.
• High-quality standards aligned with Japan’s strict regulatory environment.

2. China: The Manufacturing Hub

China has rapidly emerged as a significant source of pharmaceutical APIs, including pitavastatin calcium. The country offers cost-effective manufacturing, robust capacity, and increasingly sophisticated quality control. Several Chinese API manufacturers have achieved certifications aligning with WHO-GMP and US-FDA standards, making them attractive for global procurement.

Leading Chinese API Manufacturers:

• Qingdao Rising Chemical: Offers bulk APIs meeting international standards.
• Hengkang Pharmaceutical: Provides comprehensive API production capabilities with quality certifications.
• Zhuhai Yipin Pharmaceutical Co., Ltd.: Delivers quality APIs suitable for export markets.

Strengths:

• Economies of scale and competitive pricing.
• Growing adherence to global regulatory standards.
• Expanding R&D capacity for process improvements.

3. India: The Attribute of Cost-Effective Production

India is a prominent global player known for its large-scale API factories, experienced regulatory landscape, and cost advantages. Indian manufacturers often supply APIs that comply with international pharmacopeias, with many holding US-FDA, EMA, and other certifications.

Notable Indian API Suppliers:

• Lupin Pharmaceuticals: Offers API production with high compliance standards.
• Aurobindo Pharma: Manufactures pitavastatin calcium API for export.
• Dr. Reddy’s Laboratories: Focuses on high-quality, affordable APIs.

Strengths:

• Established regulatory pathways.
• Extensive experience in complex chemical syntheses.
• Flexible supply chains and customization options.

4. Southeast Asia and Other Regions

Additional sources in Southeast Asia, such as Vietnam and Thailand, are gradually establishing manufacturing capacities to serve regional markets. These facilities often partner with Chinese and Indian companies to enhance quality and supply consistency.

Regulatory and Quality Considerations in API Sourcing

When choosing API suppliers for pitavastatin calcium, regulatory compliance supersedes cost considerations. Suppliers must possess certifications such as WHO-GMP, US-FDA, EMA, TGA, or equivalent to ensure quality and compliance. The stability and traceability of manufacturing processes, impurity profiles, and adherence to pharmacopeial monographs (USP/NF, EP, JP) are critical.

Furthermore, transparent documentation, auditable supply chains, and independent analytical testing are essential for validating API quality and authenticity. Recent trends also emphasize sustainability, environmental controls, and ethical manufacturing practices.

Supply Chain Management and Future Trends

Protection against supply disruptions is increasingly prioritized, prompting pharmaceutical companies to diversify sourcing strategies. Dual sourcing from multiple regions mitigates risks associated with geopolitical, regulatory, or force majeure events. Strategic partnerships with suppliers holding validated manufacturing facilities and strong compliance records are crucial.

Technological advancements, including process intensification and continuous manufacturing, are projected to enhance yields, reduce costs, and improve quality. Increased adoption of API synthesis in emerging markets, coupled with stringent regulatory oversight, ensures a more resilient supply chain for pitavastatin calcium.

Conclusion

The global landscape for pitavastatin calcium APIs exhibits a robust, diverse supply chain composed of high-quality producers across Japan, China, India, and emerging regions. Japanese manufacturers maintain a reputation for technological excellence and regulatory rigor. Chinese and Indian suppliers offer cost-effective, scalable solutions with increasing compliance to international standards. Strategic sourcing, rigorous qualification procedures, and comprehensive quality assurance are paramount to securing reliable API supplies.

Key Takeaways

• Japan remains a high-quality, technologically advanced source for pitavastatin calcium APIs.
• Chinese and Indian manufacturers dominate due to cost advantages and manufacturing capacity.
• Regulatory compliance (GMP, FDA, EMA) is essential for API suppliers; certifications should be verified.
• Diversifying sourcing across regions mitigates supply chain risks.
• Continuous monitoring of manufacturing quality, regulatory updates, and technological innovations will enhance supply stability.

FAQs

1. What are the primary factors to consider when sourcing pitavastatin calcium APIs?
Regulatory compliance, manufacturing quality standards (GMP certifications), impurity profiles, supply reliability, and supplier transparency are critical.

2. Which regions dominate the production of pitavastatin calcium APIs?
Japan, China, and India are the primary producers, with each offering distinct advantages in technology, cost, and scale.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory compliance ensures safety, efficacy, and market acceptance. Suppliers with recognized certifications reduce regulatory risks and facilitate faster approval processes.

4. Are there sustainability considerations in API sourcing?
Yes. Increasingly, manufacturers and buyers evaluate environmental practices, waste management, and ethical manufacturing processes to ensure sustainable supply chains.

5. What future developments are anticipated in pitavastatin calcium API supply?
Enhanced process technologies, diversification of emerging regional suppliers, and integration of continuous manufacturing methods will likely improve supply stability and quality.

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References

[1] "Pitavastatin." US Pharmacopeia, 2023.
[2] "Global API Market Trends." IQVIA, 2022.
[3] "Pharmaceutical Industry in Japan." Japan External Trade Organization (JETRO), 2022.
[4] "Chinese API Manufacturers: Market Overview." Pharma China, 2023.
[5] "Indian Pharmaceutical Industry Overview." Department of Pharmaceuticals, Government of India, 2022.