Bulk Pharmaceutical API Sources for PIPERAZINE CITRATE

Bulk Pharmaceutical API Sources for PIPERAZINE CITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		P0449
Molport		MolPort-003-928-963
Amadis Chemical		A808202
Finetech Industry Limited		FT-0631836
BOC Sciences		144-29-6

Bulk Active Pharmaceutical Ingredient (API) Sources for Piperazine Citrate

Last updated: August 1, 2025

Introduction

Piperazine citrate is an antipyretic and anthelmintic pharmaceutical compound used primarily in the treatment of parasitic infections, such as roundworms and pinworms. Its pharmacological efficacy depends significantly on the purity, consistency, and quality of the active pharmaceutical ingredient (API). As a critical component in pharmaceutical manufacturing, sourcing reliable bulk API suppliers is pivotal. This article provides a comprehensive overview of the current landscape of bulk piperazine citrate API sources, focusing on manufacturing regions, supplier profiles, quality certifications, and the implications for pharmaceutical organizations.

Overview of Piperazine Citrate API Manufacturing

Piperazine citrate is synthesized through chemical processes involving piperazine and citric acid derivatives. The manufacturing involves stringent quality controls to meet pharmacopeial standards such as USP, EP, and JP. Given the global demand for the compound in generic and branded products, multiple manufacturers across different regions contribute to the supply chain.

Key Regions for API Production

1. India

India remains the dominant player in API manufacturing, including piperazine citrate, due to its robust pharmaceutical industry, cost competitiveness, and regulatory frameworks aligned with international standards.

• Major Suppliers: Companies such as Sun Pharmaceutical Industries Ltd., Cadila Healthcare, and Aarti Industries have established manufacturing units with capabilities in bulk API production, often compliant with international quality certifications.
• Quality Assurance: Many Indian API producers possess certifications such as WHO-GMP, ISO 9001, and adherence to US and European pharmacopeial standards.

2. China

China continues to be a significant supplier of bulk APIs, including piperazine citrate.

• Manufacturers: Several small to large-scale producers operate in China, with some integrated into multinational pharmaceutical groups.
• Regulatory Landscape: While China has made progress in GMP compliance, buyers must conduct rigorous supplier qualification processes to ensure regulatory compliance of the API for global markets.

3. Europe

European manufacturers offer high-quality APIs with a focus on stringent quality standards.

• Notable Suppliers: Companies such as Excella GmbH and Dr. Reddy's Labs have production facilities adhering to EU GMP standards.
• Market Position: Due to higher production costs, European suppliers often target premium segments and APIs for export to regulated markets.

4. United States

While the US is a major consumer market, local manufacturing of piperazine citrate API is limited; most supply comes from international sources, primarily India and China, with some US-based API producers supplying intermediates and APIs compliant with USP standards.

Supplier Profiles and Selection Criteria

Reliability: A long-standing track record of consistent supply and adherence to quality metrics.

Regulatory Compliance: Certification to cGMP, ISO, and country-specific standards, such as US FDA approval or EMA approval.

Quality Certifications: Ensure APIs meet pharmacopeial specifications, with batch-to-batch consistency, low impurity levels, and appropriate stability data.

Pricing and Lead Time: Competitive pricing structures balanced with reliable delivery timelines.

Major API Suppliers for Piperazine Citrate

Supplier	Region	Certification	Capacity	Additional Notes
Sun Pharma	India	cGMP, ISO 9001	High	Known for consistent quality and supply reliability
Aarti Industries	India	WHO-GMP, ISO	Moderate	API compliance aligned with international standards
Dr. Reddy’s Labs	India	US FDA, WHO-GMP	Moderate	Focused on high-quality APIs for export
Excella GmbH	EU	EU-GMP	Limited	Specialized European supplier with high regulatory compliance
Hubei Great Wall Pharmaceutical	China	GMP	Large	Cost-effective, requires due diligence for compliance

Regulatory and Quality Considerations

Sourcing piperazine citrate APIs for pharmaceutical applications mandates compliance with strict regulatory standards. Manufacturers should provide:

• Valid analytical and stability data.
• Certificates of analysis (CoA).
• Batch records and quality assurance documentation.
• Evidence of compliance with pharmacopeial monographs.

Quality deviations can lead to regulatory delays, product recalls, or legal liabilities. Consequently, robust supplier qualification processes, including audits and on-site inspections, are essential components of procurement strategies.

Emerging Trends and Challenges

• Regulatory Harmonization: Increased global harmonization efforts are streamlining API approval processes but demand higher compliance levels from suppliers.
• Supply Chain Resilience: Recent disruptions have emphasized the need for diversified supplier bases, especially from low-cost regions.
• Quality Assurance Emphasis: Buyers are increasingly prioritizing quality certifications over pricing to mitigate risks.
• Environmental and Sustainability Concerns: Greater emphasis on environmentally friendly manufacturing practices is influencing supplier selection.

Conclusion

The procurement of bulk piperazine citrate API demands meticulous supplier evaluation encompassing quality, regulatory compliance, capacity, and lead times. India and China dominate the supply landscape, offering cost-effective options, while Europe and the US focus on high-standard, compliant suppliers. Pharmaceutical companies must implement rigorous qualification guidelines, including supplier audits and quality audits, to ensure product safety, efficacy, and regulatory approval.

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Key Takeaways

• India and China are primary sources of bulk piperazine citrate API, offering a broad range of suppliers with varying compliance and quality standards.
• European and US suppliers typically provide higher assurance of stringent regulatory compliance but at a premium cost.
• Rigorous qualification processes—including audits, certifications, and ongoing quality surveillance—are critical for reliable API sourcing.
• Future procurement strategies should incorporate supply chain diversification and sustainability considerations.
• Staying abreast of evolving regulatory standards enhances risk mitigation and ensures market access for API sourcing.

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FAQs

1. What are the main regulatory standards to consider when sourcing piperazine citrate API?
Manufacturers should comply with pharmacopeial standards such as USP, EP, or JP and hold certifications like cGMP, ISO 9001, and country-specific approvals like US FDA or EMA.

2. How can I verify the authenticity and quality of an API supplier?
Conduct supplier audits, review certifications and analytical data, request samples, and verify prior compliance history and production capacity through third-party testing and site inspections.

3. Are there significant differences in API cost based on sourcing region?
Yes. Indian and Chinese suppliers typically offer more competitive pricing due to lower manufacturing costs, whereas European and US suppliers command higher prices due to stricter regulations and quality standards.

4. How can supply chain disruptions affect the procurement of piperazine citrate API?
Disruptions can lead to delays, increased costs, and risk of shortages. Diversifying suppliers and maintaining safety stock are common mitigation strategies.

5. What environmental considerations should influence API sourcing decisions?
Sustainability, waste management, and responsible manufacturing practices are increasingly significant. Suppliers adopting green chemistry and environmentally friendly processes may offer strategic advantages.

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References

1. United States Pharmacopeia. USP Monograph for Piperazine Citrate.
2. European Pharmacopoeia. Piperazine Citrate Monograph.
3. Indian Pharmacopeia Commission. API Standards and Certification Requirements.
4. WHO. Guidelines on Good Manufacturing Practices for Active Pharmaceutical Ingredients.
5. Industry Reports on Global API Manufacturing Trends, 2022.