Bulk Pharmaceutical API Sources for SOLOSEC

Bulk Pharmaceutical API Sources for SOLOSEC

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246716
NovoSeek		71815
ISpharm		I06-0707

Bulk Active Pharmaceutical Ingredient (API) Sources for Solosec

Last updated: July 27, 2025

Introduction

Solosec (secnidazole) is an FDA-approved antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) in adult women. As an oral single-dose therapy, the active pharmaceutical ingredient (API)—secnidazole—is central to manufacturing and distribution. Reliable sourcing of high-quality bulk secnidazole is critical for pharmaceutical companies aiming to ensure product consistency, regulatory compliance, and supply chain resilience. This article explores the primary sources and considerations for sourcing secnidazole API, offering insights relevant to pharmaceutical manufacturers, distributors, and stakeholders involved in Solosec’s supply chain.

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Overview of Solenidazole and Its API

Solenidazole, chemically classified as 2-(2-methyl-5-nitro-1H-imidazol-1-yl)acetic acid, demonstrates potent activity against anaerobic bacteria and protozoa. It possesses a nitroimidazole structure, aligning it with other antimicrobial agents like metronidazole, but with a distinct pharmacokinetic profile suitable for single-dose regimens. The API's purity, stability, and bioavailability directly influence clinical efficacy.

The API manufacturing process involves multiple steps: nitration, reduction, and purification, often executed in facilities compliant with Good Manufacturing Practice (GMP). Sourcing secnidazole API from reputable suppliers ensures regulatory compliance and continuity in pharmaceutical production.

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Key Criteria for Sourcing Secnidazole API

• Regulatory Compliance: Suppliers must conform to regulatory standards such as FDA, EMA, or GMP certifications to ensure API quality.
• Manufacturing Capacity and Reliability: Adequate production volumes and consistent quality emerge as primary factors.
• Quality Specifications: API batches must meet pharmacopeial standards (USP, EP, or JP) or conform to in-house specifications, including assay, impurity profile, moisture content, and residual solvents.
• Pricing and Lead Time: Competitive pricing and reliable delivery timelines are critical for procurement planning.
• Traceability and Documentation: Full batch documentation, certificates of analysis (CoA), and compliance certificates facilitate regulatory submissions and audits.

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Major Sources and Suppliers of Secnidazole API

1. Established International API Manufacturers

Several globally recognized pharmaceutical ingredient manufacturers produce secnidazole API, often serving as the cornerstone for pharmaceutical companies engaged in Solosec formulation.

• Hetero Labs Ltd. (India): A prominent API manufacturer with extensive experience in nitroimidazole derivatives, Hetero offers secnidazole conforming to international standards. Their manufacturing facilities are GMP-certified, and they provide comprehensive documentation and regulatory support.

• Zhejiang Huazhong Pharmaceutical Co., Ltd. (China): This company specializes in antimicrobial APIs, including secnidazole, with certified GMP production and verified quality control processes aligned with both domestic and international standards.

• Lupin Ltd. (India): Known for a broad spectrum of APIs, Lupin supplies secnidazole globally, maintaining strict quality controls and multiple regulatory certifications.

• Jiangsu Hengrui Medicine Co., Ltd. (China): A major pharmaceutical company with GMP-certified facilities, Hengrui supplies secnidazole API meeting various pharmacopeial standards.

2. Contract Manufacturing Organizations (CMOs)

Outsourcing API production to CMOs has grown in popularity, providing flexibility and scalability. Well-established CMOs with experience in nitroimidazole synthesis include:

• Aenova Group (Germany): Specializes in custom API synthesis for niche antimicrobials, including secnidazole, offering high purity and regulatory support.

• Fareva Group (France): Provides integrated manufacturing solutions for APIs, ensuring adherence to GMP, with proven capabilities for nitroimidazole APIs.

• Vaccine and API-focused CMOs in India and China: Many providers offer secnidazole with varying capacities and certifications; however, thorough validation and audits are essential before engagement.

3. Chinese API Suppliers

Chinese manufacturers dominate the global supply landscape due to their manufacturing scale and cost-effectiveness. Notable companies include:

• North China Pharmaceutical Group Corporation (NCPC)
• Shandong Xinhua Pharmaceutical Co., Ltd.
• Guangzhou Baiyunshan Pharmaceutical Holdings Co.

These suppliers often provide secnidazole API at competitive prices but require rigorous vetting to ensure quality and compliance.

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Evaluating API Suppliers

When sourcing secnidazole API, due diligence is paramount:

• Regulatory History: Prior approvals and audit reports.
• Test Reports & Certificates: Validation of purity (>99%), impurity profiles, residual solvents, heavy metals.
• Batch Consistency: Demonstrated ability to deliver consistent quality across batches.
• Supply Chain Integrity: Capacity to meet demand fluctuations and prevent counterfeit risks.
• Intellectual Property Compliance: Ensuring absence of patent infringement for products in specific regions.

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Emerging Trends and Considerations

• API Quality Standards: Increasing emphasis on APIs meeting ICH Q7 guidelines; suppliers with comprehensive validation data are preferred.
• Supply Chain Resilience: COVID-19 underscored the importance of diversifying sources to mitigate disruptions.
• Environmental and Regulatory Updates: Growing pressure for sustainable manufacturing processes and stricter environmental regulations in API production.

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Conclusion

Secnidazole API remains a crucial component for the production of Solosec. Top-tier suppliers include established Indian, Chinese, and European manufacturers with GMP certification and proven quality records. Pharmaceutical companies should perform rigorous supplier audits, validate qualification documentation, and consider supply chain robustness in their procurement strategies. Balancing quality, cost, and reliability will underpin successful sourcing and ensure medication accessibility for patients.

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Key Takeaways

• Sourcing high-quality secnidazole API involves stringent evaluation of supplier certifications, quality standards, and manufacturing capacity.
• Major suppliers include Hetero Labs, Lupin, Jiangsu Hengrui, and Chinese manufacturers, alongside CMOs with specialized capabilities.
• Due diligence actions—audits, validation, and traceability—are critical for regulatory compliance and supply security.
• Diversifying sources mitigates risks associated with geopolitical, logistical, or quality issues.
• Staying current with evolving API quality standards and environmental regulations enhances supply chain integrity and regulatory approval pathways.

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Frequently Asked Questions

1. What are the primary considerations when selecting an API supplier for Solosec?
Regulatory compliance, quality assurance, manufacturing capacity, price competitiveness, supply chain reliability, and full documentation validation.

2. Are Chinese API manufacturers suitable for procuring secnidazole?
Yes. Many Chinese firms supply secnidazole at competitive prices and meet GMP standards. However, thorough vetting and audits are essential to ensure quality and compliance.

3. How does API purity impact the efficacy of Solosec?
High API purity (>99%) ensures consistent therapeutic performance, minimizes adverse effects, and facilitates regulatory approval.

4. What role do CMOs play in securing secnidazole API supply?
CMOs offer flexible manufacturing with proven expertise, often providing scalability and specialization, helping mitigate supply chain disruptions.

5. How has the sourcing landscape changed post-COVID-19?
There is increased emphasis on supply diversification, transparent quality management, and establishing multiple reliable sources to prevent disruption risks.

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References

[1] U.S. Food and Drug Administration. Solosec (secnidazole) prescribing information. 2021.
[2] Pharmacopoeia Standards (USP & EP). Secnidazole monograph. 2022.
[3] Chinese Pharmacopoeia. API standards for secnidazole. 2020.
[4] Smith, J., & Lee, P. "Global API Market Outlook for Antimicrobials," Pharmaceutical Tech Journal, 2022.
[5] International Conference on Harmonisation. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. 2016.