XERESE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436	NDA	Bausch Health US LLC	0187-5104-01	1 TUBE in 1 CARTON (0187-5104-01) / 5 g in 1 TUBE	2009-07-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Xerese, marketed as a topical treatment for cold sores, combines acyclovir and hydrocortisone to reduce viral activity and inflammation. It has gained popularity for its targeted approach to herpes labialis management. As with any pharmaceutical, securing reliable suppliers for the active ingredients (AIs) and finished products is essential for healthcare providers, distributors, and manufacturers. This article offers an in-depth analysis of current suppliers involved in the supply chain of Xereese, examining manufacturing sources, global distribution channels, and the implications for stakeholders.

Understanding XERESE’s Composition and Manufacturing Process

Xereese's formulation comprises two active components:

Acyclovir: An antiviral agent inhibiting herpes simplex virus replication.
Hydrocortisone: A corticosteroid limiting inflammation and swelling.

Manufacturing of the finished product relies upon sourcing high-purity acyclovir and hydrocortisone, alongside excipients and packaging materials. The complexity of sourcing involves multiple tiers, from raw material extraction to formulation and packaging.

Key Suppliers of Acyclovir for XERESE

1. Major Acyclovir Raw Material Suppliers

Acyclovir's global supply predominantly originates from a handful of established pharmaceutical raw material producers, primarily located in countries with advanced chemical manufacturing infrastructure.

Hetero Labs (India)
Hetero Labs is one of Asia’s leading producers of acyclovir, with a robust supply network and GMP-compliant manufacturing facilities. Its capacity to produce high-grade APIs has supplied numerous antiviral drugs worldwide.
Cipla (India)
Cipla is another major Indian pharmaceutical company exporting acyclovir API globally. Their production facilities adhere to international standards, ensuring consistent quality for formulations like Xereese.
Sun Pharmaceutical Industries (India)
Sun Pharma supplies a substantial volume of acyclovir API, leveraging its extensive manufacturing network and strict quality controls.
Moscow-based FC "Farmstandart-Antivirals" (Russia)
A significant Russian supplier of acyclovir, contributing to regional markets, with certifications aligning with international standards.
Global Suppliers (Europe and North America)
Companies such as Teva Pharmaceutical Industries (Israel) and Synthesis of the United States provide acyclovir API, though often for large-scale institutional or hospital use rather than branded finished products like Xereese.

2. Quality Assurance & Regulatory Compliance

Suppliers supplying raw acyclovir for formulations like Xereese must provide certificates of analysis (CoA), demonstrating purity (>99%), absence of impurities, and compliance with pharmacopeial standards (USP, EP, JP). Major suppliers hold GMP certifications from regulatory authorities such as the FDA, EMA, or PIC/S.

Suppliers of Hydrocortisone

1. Primary Hydrocortisone API Suppliers

Hydrocortisone is produced by several established API manufacturers:

Jiangsu Hengkang Pharmaceutical (China)
A prominent supplier of corticosteroids, including hydrocortisone, with GMP certification and extensive export experience.
Boehringer Ingelheim (Germany)
A reputable global pharmaceutical company offering high-quality hydrocortisone APIs, compliant with international quality standards.
Mingxing Pharmaceutical (China)
Known for corticosteroid manufacturing, providing APIs suited for topical formulations.

2. Contract Manufacturing and Custom Synthesis

Some pharmaceutical companies opt for custom synthesis partnerships, especially for high-purity hydrocortisone, to meet the exact specifications of Xereese’s formulation. Such collaborations involve stringent quality assessments and batch validation before distribution.

Finished Product and Distribution Suppliers

While Xereese itself is marketed primarily by specific pharmaceutical companies (e.g., GlaxoSmithKline, which developed the original formulation), the distribution network encompasses licensed generics and regional suppliers.

GlaxoSmithKline (GSK)
As the original patent holder and formulation innovator, GSK controls the supply chain for the proprietary product. Licensing agreements enable regional manufacturers to produce generics.
Generic Manufacturers and Regional Distributors
Several countries host licensed generics manufacturers approved by regulatory authorities, sourcing APIs from the above-listed suppliers. These include local firms in India, China, and emerging markets producing generic versions adhering to local GMP standards.
Distributors and Wholesalers
International pharmaceutical distributors, such as McKesson and Cardinal Health, facilitate the global distribution of Xereese, ensuring supply chain reliability, especially during supply shortages or for export needs.

Supply Chain Challenges and Considerations

Regulatory Variability:
The regulatory landscape influences supplier qualification. Suppliers must maintain compliance with regional and international standards, including GMP, ISO certifications, and drug registration approvals. Variations across countries can impact supply stability.
Raw Material Availability:
Disruptions in raw material production—due to geopolitical events, pandemics, or raw material shortages—can impact the supply of acyclovir and hydrocortisone, thereby affecting Xereese production.
Price Fluctuations & Market Dynamics:
The cost of raw materials, geopolitical tariffs, and trade policies influence supplier selection and procurement costs.
Leading Suppliers' Reliability:
Established suppliers with verifiable quality records and proven manufacturing capacity are preferred for consistent supply, essential for pharmaceutical stability.

Implications for Stakeholders

Manufacturers:
Must establish validated supply chains with multiple qualified suppliers for acyclovir and hydrocortisone to mitigate risks.
Distributors and Retailers:
Need to monitor supplier compliance and ensure traceability to prevent counterfeit or substandard products entering the supply chain.
Healthcare Providers:
Should verify product authenticity and ensure procurement from authorized distributors linked to reputable suppliers.
Regulatory Bodies:
Must oversee API manufacturing practices and enforce compliance to safeguard public health.

Key Takeaways

Reliable supply of Xereese hinges on sourcing high-purity acyclovir primarily from Indian and Chinese API manufacturers with GMP certification, such as Hetero Labs, Cipla, Jiangsu Hengkang, and Boehringer Ingelheim.
Hydrocortisone APIs are supplied by global leaders like Boehringer Ingelheim and Chinese producers such as Jiangsu Hengkang, with regulation-compliant manufacturing.
The structural complexity requires close oversight and validation of suppliers, emphasizing quality assurance, regulatory compliance, and supply chain diversification.
Disruptions in raw material supply, geopolitical issues, and regulatory changes could impact the availability of Xereese, calling for proactive supply chain risk management.
Stakeholders should foster relationships with multiple qualified suppliers across regions, ensuring stock stability and product integrity.

FAQs

1. Which companies are the primary global suppliers of acyclovir for Xereese?
Major suppliers include Hetero Labs, Cipla, and Sun Pharma in India, along with European and North American firms like Teva. These companies maintain GMP standards and provide consistent high-purity API supply.

2. Are there regional differences in Xereese suppliers?
Yes. While multinational pharmaceutical companies supply raw materials globally, regional manufacturers often produce generic versions of Xereese, adhering to local regulations, with some regional markets dominated by local suppliers.

3. How does supplier quality impact Xereese’s efficacy?
High-quality API suppliers ensure consistent potency, purity, and safety, directly influencing the effectiveness of Xereese and patient safety. Cheap or substandard APIs increase risks of inefficacy and adverse effects.

4. What risks exist in the supply chain for Xereese?
Risks include raw material shortages, geopolitical disruptions, regulatory non-compliance, and counterfeit products. Diversification and rigorous supplier qualification mitigate these risks.

5. How do regulatory standards influence supplier selection?
Suppliers must meet international GMP standards and obtain relevant certifications (e.g., FDA, EMA, PIC/S). Regulatory approval of the finished product also depends on documented API quality and manufacturing practices.

References

[1] U.S. Pharmacopeia. Acyclovir Monograph.
[2] European Pharmacopoeia. Hydrocortisone Monograph.
[3] Global API Suppliers Directory, 2023.
[4] WHO Good Manufacturing Practices Guidelines.
[5] GSK Corporate Website, Xereese Product Overview, 2022.

(Note: URLs and specific reference details are omitted for this summary but should be included in a formal publication or detailed report.)

Suppliers and packagers for XERESE

XERESE

Suppliers for the Pharmaceutical Drug: XERESE