Suppliers and packagers for abreva

abreva

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941	NDA	Haleon US Holdings LLC	0135-0200-01	2 g in 1 TUBE (0135-0200-01)	2010-03-19
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941	NDA	Haleon US Holdings LLC	0135-0200-03	2 g in 1 BOTTLE, PUMP (0135-0200-03)	2010-03-19
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941	NDA	Haleon US Holdings LLC	0135-0200-05	2 TUBE in 1 PACKAGE (0135-0200-05) / 2 g in 1 TUBE	2010-03-19
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941	NDA	Haleon US Holdings LLC	0135-0200-06	3 BOTTLE, PUMP in 1 PACKAGE (0135-0200-06) / 2 g in 1 BOTTLE, PUMP	2010-03-19

Suppliers for the Pharmaceutical Drug: Abreva

Last updated: August 1, 2025

Introduction

Abreva, known generically as docosanol, is a widely used antiviral medication primarily designed for the topical treatment of cold sores caused by herpes simplex virus types 1 and 2. Marketed by GlaxoSmithKline (GSK), Abreva is one of the few over-the-counter (OTC) treatments approved by the U.S. Food and Drug Administration (FDA) for cold sore management. The drug’s formulation and supply chain involve multiple components, including active pharmaceutical ingredient (API) procurement, manufacturing, packaging, and distribution. Understanding the supplier landscape for Abreva is critical for stakeholders involved in pharmaceutical procurement, supply chain management, and competitive analysis.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of Abreva's efficacy is docosanol, a 22-carbon saturated fatty alcohol. Although the proprietary formulation is primarily supplied by GSK, the sourcing of the API involves multiple chemical companies specializing in fatty alcohols and related compounds.

• Global Suppliers of Fatty Alcohols:
  Docosanol can be synthesized from long-chain alcohols derived from natural fats and oils. Large suppliers such as BASF, KAO Corporation, and Wilmar International provide fat-based fatty alcohols like docosanol or long-chain alcohols that can be processed into docosanol.

  • BASF: A leading global chemical company, BASF produces a variety of fatty alcohols, including those in the C20-C24 range, suitable for docosanol synthesis. BASF's extensive R&D capabilities enable tailored alcohol formulations for pharmaceutical use.
  • KAO Corporation: A Japanese chemical conglomerate with a comprehensive portfolio of fatty alcohols, including long-chain variants pertinent to topical antiviral drugs.
  • Wilmar International: A major player in the production of fatty alcohols from palm and coconut oil derivatives, providing customizable chain-length fatty alcohols.

• Specialty API Manufacturers:
  Some pharmaceutical-focused companies manufacture or distribute chemically pure docosanol suitable for medicinal formulations, often under strict cGMP (current Good Manufacturing Practice) standards. However, licensed suppliers for API specific to Abreva are generally aligned with GSK’s procurement strategies.

Contract Manufacturing and Formulation

GSK manages the manufacturing process, likely through its own facilities or via licensed third-party contract manufacturing organizations (CMOs). These facilities handle formulation, quality control, and packaging, ensuring compliance with regulatory standards.

• GSK’s Manufacturing Networks:
  GSK operates in multiple countries, with key manufacturing sites in the UK, the US, and Asia. The company’s supply chain for Abreva involves these facilities, which may source API from international suppliers or produce it in-house.

• Third-Party CMOs:
  GSK partners with CMOs that specialize in topical pharmaceutical formulations. These organizations manage the blending, filling, and packaging processes. Their own supplier networks include regional API suppliers, chemicals vendors, and packaging firms.

Packaging and Distribution

Post-manufacturing, Abreva undergoes packaging—primarily in single-unit blister packs—and distribution through various channels including pharmacies, drug stores, and online platforms.

• Packaging Suppliers:
  Major pharmaceutical packaging companies like WestRock, Gerresheimer, or Schott offer blister packs, tubes, and ancillary materials complying with pharmaceutical standards.

• Distribution Networks:
  The drug’s distribution involves pharmacies and logistics providers with global reach. Major players include Cardinal Health, McKesson, and United Parcel Service (UPS).

Regulatory and Quality Control

Suppliers involved in the Abreva supply chain operate under strict regulatory oversight, including FDA registration for manufacturing facilities and adherence to cGMP standards.

• Certifications:
  API suppliers must demonstrate certifications such as ISO 9001, API manufacturing approvals, and compliance with Good Manufacturing Practice (GMP).
• Traceability:
  GSK maintains rigorous supplier qualification programs, emphasizing traceability of raw materials, testing for purity, and validation of manufacturing processes.

Market Dynamics and Supplier Concentration

The supply landscape for Abreva’s API and formulation components is characterized by a mix of global chemical suppliers and specialized pharmaceutical manufacturers. While large chemical companies dominate API supply for fatty alcohols, pharmaceutical companies tend to source API from a limited pool of certified manufacturers, enforcing quality standards that narrow supplier diversity.

• Geographical Concentration:
  Many suppliers are located in Asia (China, India, Japan) due to cost competitiveness and manufacturing capacity. Regulatory hurdles, such as import-export controls and certifications, influence supplier selection in different markets.

• Supply Chain Risks:
  Raw material shortages, geopolitical issues, and regulatory changes can interrupt supply. Recent global disruptions, such as the COVID-19 pandemic, have accentuated the importance of diversified supplier bases.

Emerging Trends

The pharmaceutical supply chain is increasingly focused on transparency, sustainability, and risk mitigation:

• Vertical Integration:
  Leading pharmaceutical firms may invest in or develop in-house API manufacturing to reduce dependency on third-party suppliers.

• Alternative Sources:
  Companies are exploring bio-based or synthetic routes to produce docosanol, potentially diversifying supplier options.

• Regulatory Harmonization:
  Harmonizing international standards facilitates smoother supply chains, particularly for OTC drugs like Abreva.

Conclusion

The supply chain for Abreva involves a network of chemical suppliers providing specialized fatty alcohols, pharmaceutical manufacturers ensuring quality and compliance, and logistical partners supporting global distribution. While GSK maintains tight control over the formulation and manufacturing process, key raw materials are sourced from established global chemical companies, with a notable concentration in Asia and Europe. Ongoing supply chain resilience and transparency efforts aim to sustain the drug's availability amidst fluctuating global market conditions.

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Key Takeaways

• API Sourcing: Abreva’s active ingredient, docosanol, primarily derives from large chemical suppliers specializing in fatty alcohols, predominantly based in Asia and Europe.
• Manufacturing Control: GSK conducts formulation and packaging through its own facilities and trusted CMOs, maintaining strict regulatory standards.
• Supply Chain Risks: Market concentration, geopolitical issues, and pandemic-related disruptions necessitate strategic diversification of suppliers.
• Regulatory Compliance: Suppliers must adhere to cGMP and obtain necessary certifications, ensuring product quality and safety.
• Emerging Trends: Bio-based manufacturing, increased transparency, and supply chain resilience are shaping future sourcing strategies.

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5 Unique FAQs

1. Who are the primary suppliers of docosanol for Abreva?
While GSK does not publish specific supplier details, major global chemical companies such as BASF, KAO Corporation, and Wilmar International are key suppliers of fatty alcohols like docosanol precursors used in pharmaceutical formulations.

2. Is the API for Abreva produced in-house or outsourced?
GSK likely sources the API from specialized chemical manufacturers due to the complexity and regulatory requirements, although some manufacturing may be integrated within GSK’s own facilities.

3. How does GSK ensure the quality and safety of its Abreva supply chain?
GSK enforces strict supplier qualification, requiring GMP certification, regular audits, and compliance with international quality standards to ensure consistent quality and regulatory adherence.

4. Are there alternative sources or substitutes for the API used in Abreva?
Currently, no widely accepted substitutes exist for docosanol's specific antiviral activity. However, bioengineered or synthetic routes for producing similar compounds are under research, which may diversify future supply options.

5. What are the main risks in the Abreva supply chain?
Supply disruptions stemming from raw material shortages, geopolitical issues, regulatory changes, or manufacturing delays pose risks, emphasizing the need for diversified sourcing and contingency planning.

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Sources

[1] GlaxoSmithKline. (2023). Abreva product information.
[2] ICIS Chemical Business. (2022). Global fatty alcohols market analysis.
[3] U.S. Food and Drug Administration. (2022). Regulatory guidelines for OTC topical drugs.
[4] KAO Corporation. (2023). Fatty alcohol products portfolio.
[5] Wilmar International. (2022). Fatty alcohols and oil derivatives overview.