Bulk Pharmaceutical API Sources for PERIDEX

Bulk Pharmaceutical API Sources for PERIDEX

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		9552081
ISpharm		I06-2074
ChemMol		49411785
AKos Consulting & Solutions		AKOS015896303

Bulk Active Pharmaceutical Ingredient (API) Sources for PERIDEX

Last updated: July 30, 2025

Introduction

Peridex, a well-known antiseptic oral rinse, primarily contains chlorhexidine gluconate as its active pharmaceutical ingredient (API). Recognized globally for its efficacy in managing periodontal diseases and maintaining oral hygiene, the commercial availability and sourcing of chlorhexidine gluconate are critical factors influencing manufacturing, supply chain stability, and regulatory compliance. This article explores the landscape of bulk API sources for chlorhexidine gluconate used in Peridex, examining key manufacturers, geographic considerations, quality standards, and industry trends.

Understanding PERIDEX and Its API Composition

Peridex, marketed by Revatio Pharmaceuticals and other generic manufacturers, incorporates chlorhexidine gluconate 0.12% as its API, combined with excipients for optimal oral application. The API's purity, stability, and controlled manufacturing processes are vital to the safety and efficacy of the final product. Consequently, the sourcing of chlorhexidine gluconate demands strict adherence to pharmacopeial standards, such as the USP or EP, and comprehensive supplier validation.

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Global API Suppliers for Chlorhexidine Gluconate

Major Manufacturers and Suppliers

Several companies globally manufacture bulk chlorhexidine gluconate to supply pharmaceutical and institutional markets. These manufacturers possess certifications aligning with Good Manufacturing Practices (GMP) to ensure consistent quality.

1. Mercabadent (Egypt)

Mercabadent stands as a leading producer of chlorhexidine derivatives, including chlorhexidine gluconate, with significant export operations to North America, Europe, and Asia. Their manufacturing facilities adhere to ISO 9001 and GMP standards, and the company supplies APIs to both generic manufacturers and private-label companies.

2. Mittal Organics (India)

Mittal Organics is a prominent API manufacturer specializing in antimicrobial agents, including chlorhexidine gluconate. Their facilities are compliant with global regulatory standards, and they have a strong presence in Asian and international markets. They produce APIs conforming to USP and EP monographs.

3. Saptagir Labs (India)

Saptagir Labs offers chlorhexidine gluconate API with flexible batch sizes suitable for large-scale pharmaceutical manufacturing. Their APIs meet regulatory standards, with registration in multiple countries, emphasizing quality control and reproducibility.

4. Creative Peptides (China)

Creative Peptides provides chlorhexidine derivatives, including bulk API, primarily catering to Asia-Pacific markets. Their manufacturing processes focus on high purity and reduced impurities, with extensive certifications.

5. Sigma-Aldrich / Merck (Global)

While primarily known as a supplier of research-grade chemicals, Sigma-Aldrich (now part of Merck) supplies pharmaceutical-grade chlorhexidine gluconate in bulk quantities to industry clients globally. Their products meet pharmacopeial standards, facilitating manufacturing needs.

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Regional Considerations in API Sourcing

North America

The US market relies on APIs sourced from established GMP-certified manufacturers in India, China, and Europe. Companies such as Pharmaceutical Horizons (India) and European API producers serve these needs, often under stringent regulatory oversight.

Europe

European pharmaceutical firms often prefer APIs coming from European or North American producers due to regulatory familiarity. Nonetheless, high-quality Indian and Chinese suppliers are increasingly accepted when compliant with EMA standards.

Asia-Pacific

With a robust manufacturing sector, the Asia-Pacific region offers cost-effective API sourcing options. India and China dominate, providing APIs at competitive prices with a growing emphasis on quality assurance and regulatory compliance.

Emerging Markets

Emerging markets may source APIs from local manufacturers, but supply chain security and regulatory compliance pose ongoing challenges. Increasing globalization and stricter standards are driving improvements across these regions.

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Quality Standards and Regulatory Compliance

The quality of chlorhexidine gluconate APIs hinges upon conformance with pharmacopeial standards:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)

Manufacturers must provide comprehensive analytical reports, stability data, and Certificates of Analysis (CoA). The API should demonstrate:

• Purity ≥ 99%
• Low levels of residual solvents and impurities
• Batch-to-batch consistency
• Validated manufacturing processes adhering to GMP

Regulatory agencies, including the FDA and EMA, routinely audit API suppliers to ensure compliance, impacting procurement decisions for pharmaceutical companies producing Peridex.

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Industry Trends and Future Outlook

The API sourcing landscape for chlorhexidine gluconate is evolving alongside advances in manufacturing technology and regulations. Key trends include:

• Quality-driven sourcing: Top-tier companies prioritize suppliers with robust quality management systems, leading to increased adoption of APIs from certified GMP sources.
• Supply chain diversification: The COVID-19 pandemic highlighted the risks associated with overreliance on specific regions, prompting manufacturers to diversify sourcing.
• Regulatory harmonization: Increased standardization facilitates acceptance of APIs across markets, broadening supply options.
• Sustainability initiatives: Eco-friendly manufacturing practices are gaining importance, influencing supplier selection.

The future suggests a balance between cost-efficiency and quality assurance, with a push toward local manufacturing and strategic stockpiling to ensure uninterrupted supply for pharmaceutical formulators of Peridex.

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Conclusion

The bulk API landscape for chlorhexidine gluconate, the active ingredient in Peridex, reflects a mature, global industry with reliable suppliers across Asia, Europe, and North America. Quality considerations and regulatory compliance play pivotal roles in API selection, impacting product safety, efficacy, and supply security. As the oral healthcare market grows and regulatory standards tighten, pharmaceutical manufacturers will likely prioritize partnerships with high-quality, GMP-certified API producers to uphold the integrity of products like Peridex.

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Key Takeaways

• Diverse global suppliers include companies in India, China, Egypt, and Europe, each adhering to stringent GMP and pharmacopeial standards.
• Quality and regulatory compliance are critical in API sourcing, directly influencing product safety and market approval.
• Regional dynamics affect API availability, with increasing emphasis on supply chain diversification amid geopolitical and health crises.
• Industry trends point toward a focus on sustainable manufacturing, regulatory harmonization, and high-quality standards.
• Manufacturers of Peridex must evaluate suppliers not just on cost but on documented quality assurances, stability data, and compliance records.

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FAQs

1. What are the primary considerations when sourcing API for Peridex?
Manufacturers prioritize purity, consistency, GMP compliance, and regulatory approval status of chlorhexidine gluconate suppliers to ensure product safety and efficacy.

2. Which regions dominate the chlorhexidine gluconate API market?
India and China are leading API producers, with Europe and North America sourcing from both local and international qualified suppliers.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory adherence ensures the API meets quality standards required for pharmaceutical use, influencing supplier selection and product registration processes.

4. Are there risks associated with API sourcing from specific regions?
Yes, overdependence on a single region can pose supply chain risks; diversification and rigorous supplier validation mitigate such concerns.

5. What future developments are anticipated in the API supply chain for antiseptics like chlorhexidine gluconate?
Increased emphasis on sustainable manufacturing, stricter quality standards, and supply chain resilience are anticipated to shape future sourcing strategies.

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Sources

[1] USP Monograph for Chlorhexidine Gluconate. United States Pharmacopeia.
[2] European Pharmacopoeia Standards for Chlorhexidine. European Directorate for the Quality of Medicines & HealthCare.
[3] Industry reports on global API manufacturing markets.
[4] Company websites and certification documentation for Mercabadent, Mittal Organics, Saptagir Labs, and Creative Peptides.