Suppliers and packagers for PERIDEX

PERIDEX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
3m	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028	NDA	Solventum US LLC	48878-0620-1	473 mL in 1 BOTTLE (48878-0620-1)	1986-08-13
3m	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028	NDA	Solventum US LLC	48878-0620-2	1893 mL in 1 BOTTLE, DISPENSING (48878-0620-2)	1986-08-13
3m	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028	NDA	Solventum US LLC	48878-0620-3	118 mL in 1 BOTTLE (48878-0620-3)	1986-08-13

Suppliers for the Pharmaceutical Drug: PERIDEX

Last updated: July 28, 2025

Introduction

Peridex, a well-known antimicrobial mouthwash containing chlorhexidine gluconate, is widely used in dental care for controlling plaque and gingivitis. As a critical product in periodontal therapy, its supply chain stability directly impacts dental practices, hospitals, and consumers worldwide. Understanding the landscape of suppliers for Peridex provides insights into market dynamics, manufacturing, and distribution channels that influence pricing, availability, and regulatory compliance.

Overview of Peridex and Its Manufacturer

Peridex is a trademarked brand of chlorhexidine gluconate oral rinse, marketed primarily by GlaxoSmithKline (GSK). GSK holds the patent, regulatory approvals, and manufacturing rights, making it the principal source of Peridex (marketed as Peridex in the US and as PerioGard in some markets) [1]. As a brand-owned product, GSK’s manufacturing and supply chain are critical for ensuring consistent availability.

Primary Manufacturers and Suppliers

1. GlaxoSmithKline (GSK)

GSK is the principal supplier of Peridex, controlling the manufacturing process across various facilities globally. The company’s integrated supply chain manages raw material procurement, manufacturing, quality control, packaging, and distribution. GSK’s manufacturing facilities for chlorhexidine-based products are located mainly in Europe, North America, and Asia, facilitating regional distribution and regulatory compliance [2].

2. Raw Material Suppliers for Chlorhexidine Gluconate

Chlorhexidine gluconate, the active pharmaceutical ingredient (API) in Peridex, is produced by several chemical manufacturers worldwide. These API suppliers supply chlorhexidine gluconate to pharmaceutical companies, including GSK, under strict quality standards. Leading manufacturers include:

• Sumitomo Chemical (Japan): A global supplier with extensive chemical manufacturing expertise, providing high-purity chlorhexidine gluconate [3].

• AkzoNobel (Netherlands): Known for specialty chemicals, including ingredients used in pharmaceutical formulations.

• Fresenius Kabi (Germany): Supplies APIs and pharmaceutical excipients, potentially including chlorhexidine gluconate.

• Delpharm and HOSPIRA (A Pfizer subsidiary): Contract manufacturing organizations (CMOs) that may produce finished chlorhexidine products under license.

3. Contract Manufacturing Organizations (CMOs)

Some production of chlorhexidine gluconate and finished formulations may involve CMOs to meet manufacturing scale and regional demand. These CMOs provide manufacturing services, quality assurance, and regulatory compliance for GSK or other brand owners.

4. Distributors and Wholesalers

Once manufactured, Peridex is distributed through a vast network of pharmaceutical wholesalers and distributors. Major global distributors include:

• McKesson Corporation
• AmerisourceBergen
• Cardinal Health

Regional distributors handle distribution in specific markets, ensuring timely supply to dental clinics and hospitals.

Market Dynamics and Supply Chain Considerations

Global Supply Chain Challenges

The supply of Peridex hinges on multiple factors:

• Raw Material Availability: Chlorhexidine gluconate's production depends on the availability of high-quality chemical precursors, which can be impacted by geopolitical factors, regulatory changes, or raw material shortages.

• Manufacturing Capacity: GSK’s manufacturing plants must maintain operational efficiency and regulatory compliance. Any disruption can lead to shortages.

• Regulatory Approvals: Variations in regulatory requirements across regions can complicate manufacturing and distribution, especially when introducing generic or alternative formulations.

• Patent Expirations and Generics: When patents on chlorhexidine gluconate formulations expire, generic manufacturers seek regulatory approval to produce alternative products, increasing competition and potentially diversifying supply sources [4].

Emerging Supply Sources and Generics

Although GSK is the primary provider of Peridex, the expiration of patents and increased regulatory approvals have led to a surge of generic chlorhexidine mouthwashes, providing alternative sources for healthcare providers. These generics are often produced by regional pharmaceutical companies with local manufacturing facilities, expanding supply options but raising concerns about quality assurance and regulatory approval standards.

Regulatory Environment and Quality Standards

GSK adheres to stringent Good Manufacturing Practices (GMP) mandated by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional authorities. Generic suppliers and CMOs are likewise required to meet these standards to ensure product safety and efficacy. Quality assurance processes in the supply chain are critical, especially given the product's widespread use in oral healthcare.

Key Suppliers and Partnerships

GSK continues to strengthen its supply chain through strategic partnerships, licensing agreements, and quality vendor management. The company's focus remains on maintaining consistent product quality and supply continuity amid regional regulatory variations and market demand fluctuations.

Conclusion

The primary supplier for Peridex remains GlaxoSmithKline, leveraging a sophisticated, vertically integrated supply chain with reliance on high-quality chlorhexidine gluconate API producers such as Sumitomo Chemical and other chemical manufacturers. The evolving landscape includes increased generic competition, regional suppliers, and CMOs, all of which influence pricing, availability, and product integrity. For healthcare stakeholders, understanding these supply sources aids in strategic planning, procurement, and risk mitigation.

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Key Takeaways

• GSK dominates Peridex supply, controlling API procurement, manufacturing, and distribution channels.

• High-quality chlorhexidine gluconate API sources, such as Sumitomo Chemical, underpin product integrity.

• Regional generic manufacturers contribute to diversification but require vigilant quality assurance.

• Supply chain resilience depends on raw material access, manufacturing capacity, and regulatory alignment.

• Market dynamics will continue to evolve with patent expirations and increased competition from generics.

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FAQs

1. Are there generic alternatives to Peridex?
Yes, following patent expirations, several generic chlorhexidine mouthwashes are available globally, produced by various regional pharmaceutical companies. These generics often offer comparable efficacy but require scrutiny regarding quality standards.

2. How does the supply chain impact Peridex availability?
Disruptions in raw material supply, manufacturing issues, or regulatory delays can lead to shortages. GSK’s integrated supply system aims to mitigate these risks through diversified sourcing and regional manufacturing.

3. Can other companies manufacture chlorhexidine gluconate?
While multiple companies produce chlorhexidine gluconate API, GSK maintains control over the formulation and distribution of Peridex in certain regions. Other manufacturers produce chlorhexidine-based products, but not all are licensed or approved as equivalent alternatives.

4. What role do CMOs play in Peridex’s supply?
Contract Manufacturing Organizations support GSK by providing manufacturing capacity, especially during periods of high demand or when expanding into new markets, ensuring ongoing supply continuity.

5. How do regulatory standards influence the supply of Peridex?
Stringent GMP compliance and regional regulatory requirements govern manufacturing practices, ensuring safety and efficacy. Non-compliance can lead to production halts or import bans, impacting supply.

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Sources

1. GSK. Peridex Product Information.
2. GSK Annual Report 2022.
3. Sumitomo Chemical – Chemical Product Portfolio.
4. U.S. Patent Office. Patent Expirations and Market Impacts.