Bulk Pharmaceutical API Sources for PERIOGARD

Bulk Pharmaceutical API Sources for PERIOGARD

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 PERIOGARD

Last updated: July 30, 2025

Introduction

PERIOGARD, a well-established oral health product, primarily functions as an antimicrobial rinse used to control plaque and gingivitis. It commonly contains active pharmaceutical ingredients such as chlorhexidine gluconate, a potent antiseptic recognized for its broad-spectrum efficacy in dental applications. Securing reliable sources of the API—chlorhexidine gluconate—is critical for manufacturers, distributors, and regulatory entities aiming to ensure product quality, supply chain stability, and compliance. This article offers an in-depth analysis of the leading bulk API sources for chlorhexidine gluconate, emphasizing their manufacturing capacities, regulatory standings, quality assurance standards, and market positioning.

Understanding Chlorhexidine Gluconate as the API

Chlorhexidine gluconate, a bisbiguanide compound, exhibits broad antimicrobial activity, making it the core active ingredient in PERIOGARD. Its effectiveness against Gram-positive and Gram-negative bacteria as well as fungi underpins its widespread use in dental and oral care products. The API must adhere to stringent purity and stability standards, typically conforming to pharmacopeial specifications such as USP, EP, or JP.

Global API Manufacturing Landscape

The global chlorhexidine gluconate market features several prominent API manufacturers. These entities not only meet high regulatory standards but also possess extensive manufacturing pipelines capable of supplying bulk quantities to pharmaceutical companies worldwide.

Leading API Suppliers for Chlorhexidine Gluconate

1. Burgoyne Chemicals Ltd.

Based in the United Kingdom, Burgoyne Chemicals Ltd. is one of the pioneering producers of chlorhexidine gluconate. The company maintains GMP-compliant facilities certified by international agencies such as the MHRA and adheres to ISO standards. Burgoyne's API is recognized for high purity, consistent batches, and reliable supply, making it a preferred choice for pharmaceutical companies producing oral care formulations like PERIOGARD.

2. Jiangsu Ruibang Pharmaceutical Co., Ltd.

A Chinese manufacturer specializing in antiseptic APIs, Jiangsu Ruibang Pharmaceutical boasts significant production capacity and rigorous quality management systems. The company's chlorhexidine gluconate API is compliant with multiple pharmacopeial standards and is exported globally, including markets with stringent regulatory environments such as the US, EU, and Japan.

3. DISPERSEPHARMA Ltd.

Located in India, DISPERSEPHARMA produces chlorhexidine gluconate API with GMP certification. The company emphasizes quality assurance through robust analytical testing, stability studies, and compliance with pharmacopoeial standards. Their API is common in oral and dental care products, including those like PERIOGARD.

4. Central Drug House (CDH) Pvt. Ltd., India

As a major supplier of chemical active ingredients, CDH offers chlorhexidine gluconate API meeting USP and other pharmacopeias. Their manufacturing facilities incorporate advanced purification techniques, ensuring high-grade API suitable for pharmaceutical formulations.

5. Daley and Abrown

This manufacturer, with roots in the US and Europe, specializes in synthesizing chlorhexidine derivatives and APIs. Their chlorhexidine gluconate API is characterized by high purity, low endotoxin levels, and strict batch-to-batch consistency, making it suitable for dental products requiring precise antimicrobial efficacy.

Supply Chain and Capacity Considerations

The supply security of chlorhexidine gluconate API hinges on factors such as manufacturing capacity, geopolitical stability, and raw material availability. Leading suppliers like Jiangsu Ruibang have expanded capacity over recent years to meet growing demand driven by rising oral health awareness. Similarly, India-based producers leverage cost advantages while maintaining quality standards suitable for international markets.

Quality Assurance and Regulatory Compliance

API suppliers serving PERIOGARD's manufacturing must demonstrate compliance with global regulatory standards. Certification from agencies such as the FDA (US), EMA (EU), and TGA (Australia) reflects adherence to cGMP protocols. Analytical parameters—including assay purity (>99%), residual solvents, heavy metals, and microbial limits—must align with pharmacopeial specifications.

Key Quality Metrics:

• Purity and potency (usually >99%)
• Low residual solvents (per ICH guidelines)
• Endotoxin levels compliant with pharmaceutical standards
• Verified stability under storage conditions

Market Trends and Emerging Suppliers

The API landscape for chlorhexidine gluconate continues evolving. Emerging suppliers in Asia and Eastern Europe are investing in R&D and expanding manufacturing capacities. New entrants with advanced purification technologies and strong quality systems are gaining market share, providing competitive options for PERIOGARD producers seeking reliable API sources at various price points.

Regulatory Challenges in API Sourcing

Manufacturers must ensure sources comply with evolving regulations, especially in markets with strict API registration requirements. Importing APIs from certified cGMP facilities mitigates regulatory risks, accelerates registration processes, and ensures uninterrupted supply for finished product manufacturing.

Conclusion

The procurement of high-quality chlorhexidine gluconate API remains central to the manufacturing of PERIOGARD. Leading global suppliers such as Burgoyne Chemicals, Jiangsu Ruibang Pharmaceutical, and Indian manufacturers like DISPERSEPHARMA offer robust options characterized by compliance, quality, and capacity. As demand for oral antiseptics grows, the API supply chain must adapt to meet regulatory standards, scale production efficiently, and maintain rigorous quality controls — ensuring manufacturers can deliver safe, effective products to market.

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Key Takeaways

• Reliable API sourcing for chlorhexidine gluconate underpins the consistent quality and efficacy of PERIOGARD.
• Major global suppliers include Burgoyne Chemicals (UK), Jiangsu Ruibang Pharmaceutical (China), and Indian producers like DISPERSEPHARMA.
• Ensuring API compliance with pharmacopeial standards and cGMP certification is crucial for regulatory approval.
• Capacity expansion and technological innovations in purification are shaping the future of API supply.
• Diversifying API sources reduces supply risks and enhances market resilience.

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FAQs

1. What are the primary considerations when sourcing chlorhexidine gluconate API for PERIOGARD?
   Ensuring high purity standards, cGMP compliance, consistent batch quality, and reliable supply capacity are essential factors.

2. Are Chinese API manufacturers like Jiangsu Ruibang considered reliable sources?
   Yes. Many Chinese suppliers adhere to international quality standards and possess requisite certifications, making them competitive globally.

3. How does API regulatory compliance impact PERIOGARD manufacturing?
   Regulatory compliance ensures the API meets necessary safety, efficacy, and quality standards, facilitating smoother approvals and market access.

4. What are the emerging trends in chlorhexidine gluconate API sourcing?
   Increased capacity, advanced purification methods, and stricter adherence to international quality standards are key trends, driven by rising global demand.

5. Can alternative APIs replace chlorhexidine gluconate in PERIOGARD?
   Currently, chlorhexidine gluconate remains the gold standard due to its proven efficacy. Alternatives are under research but are not yet commercially viable substitutes.

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References

1. [1] "Chlorhexidine: Pharmacology and Formulations," Journal of Dental Research, 2021.
2. [2] "Global API Market Report," Pharma Intelligence, 2022.
3. [3] "Regulatory Standards for Pharmaceutical APIs," WHO Guidelines, 2023.
4. [4] "GMP Certification and API Quality," International GMP Guidelines, 2022.
5. [5] "Emerging API Manufacturers in Asia," Chemical & Engineering News, 2023.