DENAVIR: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-0896-55	1 TUBE in 1 CARTON (0378-0896-55) / 5 g in 1 TUBE	2022-11-16
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629	NDA	Mylan Pharmaceuticals Inc.	0378-9720-55	1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE	2018-09-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Denavir (generic: penciclovir) is an antiviral medication primarily prescribed for the treatment of herpes labialis, commonly known as cold sores. As a topical formulation, Denavir has captured significant market attention due to its efficacy in reducing the duration and severity of herpes outbreaks. The pharmaceutical supply chain for Denavir involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation developers, and distribution channels. This analysis provides a comprehensive overview of the key suppliers involved in the production and distribution of Denavir, highlighting their roles, market positioning, and implications for industry professionals.

Active Pharmaceutical Ingredient (API) Suppliers for Penciclovir

The core of Denavir’s production relies on high-quality penciclovir API. The quality, sourcing, and availability of API manufacturers directly influence drug supply stability, regulatory compliance, and pricing.

Major API Manufacturers

1. Synthesis of Penciclovir

Penciclovir’s synthesis involves complex chemical processes, typically requiring specialized pharmaceutical synthesis expertise. Several companies, predominantly within Asia and Europe, are engaged in the production of high-grade penciclovir APIs:

Hainan Yatai Pharmaceutical Co., Ltd. (China): Known for large-scale API manufacturing, Hainan Yatai supplies penciclovir to various generic and branded drug producers globally. The company emphasizes adherence to Good Manufacturing Practices (GMP) and has obtained several international certifications (e.g., ISO, GMP).
Daewoong Pharmaceutical (South Korea): A notable pharmaceutical company with robust API production capabilities. Daewoong supplies penciclovir to its proprietary formulations and third-party manufacturers, emphasizing stringent quality control.
FAMARS (France): Specializes in contract manufacturing of APIs including antiviral compounds like penciclovir. Their focus on European markets provides an assurance of compliance with Western regulatory standards.
Others: Several Indian API manufacturers, such as Gufic Biosciences and Hetero Labs, have reported capacity for producing penciclovir, capitalizing on India’s strong API sector.

2. API Quality and Regulatory Considerations

API suppliers must meet global regulatory standards, including US FDA, EMA, and PIC/S certifications, to ensure broad market access. The quality of penciclovir APIs impacts drug efficacy, safety, and regulatory approval.

3. Supply Chain Risks

The concentrated API supply in China, South Korea, and India necessitates risk management strategies, such as multi-sourcing and quality audits, to mitigate potential disruptions—especially amid geopolitical and logistical challenges.

Formulation and Contract Manufacturers

Beyond API sourcing, pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) for formulation and finished product assembly.

Bionpharma (United States): Provides contract manufacturing for topical antiviral medications and has facilities compliant with cGMP standards, serving as a key player in the US market.
Mundipharma (Germany): Responsible for the production of Denavir in Europe, offering expertise in topical drug formulations.
Chinese Contract Manufacturers: Multiple regional CMOs support generic drug producers with formulation, filling, and packaging of penciclovir topical creams, offering cost-effective options with regulatory support.

Distribution and Supply Chain

The distribution network for Denavir involves wholesalers, pharmacy chains, and hospitals.

Major Distributors: McKesson, Cardinal Health, and AmerisourceBergen are dominant in North America, ensuring broad access to pharmacies and clinics.
Regional Distributors: Localized distributors in Europe, Asia, and emerging markets facilitate regional access, often involving partnerships with local pharmacies and healthcare facilities.
Supply Chain Challenges: Stock shortages have been reported during the COVID-19 pandemic, underscoring vulnerabilities within the distribution network. Ensuring diversified sourcing and inventory management remains critical.

Market Dynamics and Emerging Suppliers

With patent expirations and the rise of generic versions, new entrants have emerged in the penciclovir supply ecosystem.

Generics Manufacturers: Companies like Sandoz, Mylan (now part of Viatris), and Teva Pharmaceuticals are expanding their penciclovir portfolios, often sourcing APIs from established suppliers.
Innovative Suppliers: Some biotech firms explore alternative antiviral compounds, potentially impacting the future demand for penciclovir-based therapies.

Regulatory and Quality Assurance

Suppliers must navigate complex regulatory environments, with stringent requirements across jurisdictions. Suppliers with robust quality systems, validated manufacturing processes, and transparent supply chain histories are favored.

Certification and Audits: Regular audits by regulatory agencies, including FDA inspections, ensure ongoing compliance.
Traceability: Implementing serialization and batch tracking mechanisms enhances supply chain transparency, safeguarding against counterfeit or substandard products.

Conclusion

The supply of Denavir hinges on a diversified network of API producers, formulators, and distributors. Major API suppliers such as Hainan Yatai, Daewoong, and FAMARS serve as critical pillars, with quality and regulatory compliance as primary considerations. As the market evolves amid patent expiries and increasing generic competition, new suppliers and manufacturing partnerships are expected to emerge. Ensuring a resilient, compliant, and transparent supply chain remains paramount for stakeholders aiming to maintain drug availability and meet healthcare demands globally.

Key Takeaways

API sourcing is concentrated in Asia and Europe, with suppliers like Hainan Yatai, Daewoong, and FAMARS leading the market.
Regulatory compliance and quality assurance are non-negotiable factors influencing supplier selection and market access.
Supply chain risks—stemming from geopolitical, logistical, and pandemic-related disruptions—necessitate multi-sourcing strategies.
Emerging generic manufacturers are expanding their supplier networks, increasing competition and potentially lowering prices.
Transparent and traceable supply chains are essential to prevent counterfeit risks and ensure patient safety.

FAQs

Who are the primary API suppliers for penciclovir used in Denavir?
The leading API suppliers include Hainan Yatai Pharmaceutical (China), Daewoong Pharmaceutical (South Korea), and FAMARS (France). These companies manufacture high-quality penciclovir APIs meeting international regulatory standards.
What regulatory standards do API manufacturers for Denavir need to meet?
API producers must comply with GMP (Good Manufacturing Practices), and often hold ISO certification, FDA approval (for US markets), or EMA certification (for European markets), ensuring product quality and safety.
Are there risks associated with API supply concentration for Denavir?
Yes. Dependence on a limited number of suppliers, mainly in Asia and Europe, poses risks such as supply disruptions, price volatility, and regulatory delays. Diversification and stringent quality audits mitigate these risks.
How has the patent landscape affected suppliers and generic entrants?
The expiration of Denavir’s patent has facilitated entry by generic manufacturers, increasing competition. This shifts the supply dynamics, often leading to lower prices and enhanced access, with new suppliers expanding market share.
What role do distribution channels play in Denavir’s global availability?
Distributors like McKesson and Cardinal Health are critical in ensuring the drug’s availability to pharmacies and healthcare providers across regions. Efficient distribution ensures minimal stock shortages and quick market response.

Sources:

[1] U.S. Food & Drug Administration (FDA). API Manufacturer Compliance Data.
[2] European Medicines Agency (EMA). Chemical and API Certification Lists.
[3] GlobalData. Pharmaceutical Industry Reports.
[4] MarketWatch. Top API Suppliers in the Antiviral Market.
[5] Company Websites and Regulatory Filings.

Suppliers and packagers for DENAVIR

DENAVIR

Suppliers for the Pharmaceutical Drug: DENAVIR