Suppliers and packagers for generic pharmaceutical drug: FAMCICLOVIR

FAMCICLOVIR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	FAMCICLOVIR	famciclovir	TABLET;ORAL	091480	ANDA	Apotex Corp.	60505-3246-3	30 TABLET, FILM COATED in 1 BOTTLE (60505-3246-3)	2011-12-20
Apotex	FAMCICLOVIR	famciclovir	TABLET;ORAL	091480	ANDA	Apotex Corp.	60505-3247-3	30 TABLET, FILM COATED in 1 BOTTLE (60505-3247-3)	2011-12-20
Aurobindo Pharma Ltd	FAMCICLOVIR	famciclovir	TABLET;ORAL	091114	ANDA	Rising Pharma Holdings, Inc.	64980-349-03	30 TABLET, FILM COATED in 1 BOTTLE (64980-349-03)	2011-03-21

Suppliers for the Pharmaceutical Drug: FAMCICLOVIR

Last updated: July 28, 2025

Introduction

Famiciclovir is an antiviral medication primarily used for the treatment of herpes simplex virus infections and herpes zoster. As a prodrug of penciclovir, it exhibits enhanced bioavailability, making it effective in managing various herpes-related conditions. The global demand for famciclovir has necessitated a reliable and diverse supply chain involving multiple manufacturers, generic producers, and authorized distributors. Understanding the landscape of suppliers for famciclovir is crucial for pharmaceutical companies, healthcare providers, and stakeholders involved in procurement and distribution.

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Market Overview and Key Players

The famciclovir supply chain comprises both brand-name and generic drug manufacturers. While the original formulation was developed by major pharmaceutical firms, a significant portion of global supply now stems from generic manufacturers following patent expirations. These suppliers operate across different regions, including North America, Europe, Asia, and other emerging markets.

Original Brand Suppliers

• Novartis: Originally developed famciclovir under the brand name Famvir, Novartis remains a key supplier in markets where patent protection was maintained longer and where the original formulation is still in use. Its extensive distribution network ensures consistent availability in developed nations.

Generic Manufacturers

Post-patent expiration, the supply landscape expanded significantly with numerous generic firms. The following are notable suppliers:

• Dr. Reddy’s Laboratories (India): A prominent global generic pharmaceutical company, Dr. Reddy’s produces famciclovir with strict compliance to international quality standards (GMP). Their products are widely distributed across Asia, Europe, and North America.

• Hetero Labs (India): Recognized for producing affordable generic medicines, Hetero offers famciclovir APIs and finished dosages marketed under various brand names or as generic equivalents.

• Cadila Healthcare (India): A key player with manufacturing facilities complying with global standards, Cadila supplies famciclovir for multiple markets, emphasizing cost-effective production.

• Sun Pharmaceutical Industries (India): Sun Pharma’s extensive portfolio includes famciclovir, and their global reach enhances supply stability.

• Mingde Pharma (China): As part of China's expanding pharmaceutical industry, Mingde Pharma manufactures famciclovir APIs and finished formulations for domestic and export markets.

• Aurobindo Pharma (India): Known for producing high-quality generics, Aurobindo supplies famciclovir mainly for markets in North America and Europe.

• Intas Pharmaceuticals (India): Committed to affordable generics, Intas offers famciclovir API and finished products to various regions.

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Contract Manufacturing and API Suppliers

The supply chain also involves contract manufacturing organizations (CMOs) and API (Active Pharmaceutical Ingredient) producers, which play a vital role in meeting global demand efficiently and securely.

• Zhejiang Hisun Pharmaceutical (China): An API supplier specializing in antivirals, including famciclovir, with GMP certification.

• Hovione (Portugal): Provides advanced manufacturing for APIs and intermediates, supporting global supply continuity.

• Fap Pharmaceuticals (India): Focused on API synthesis with an emphasis on quality compliance.

• Lek Pharmaceuticals (Slovenia): Known for pharmaceutical ingredients, including APIs used in antiviral drugs.

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Distribution Channels and Geographical Coverage

Suppliers distribute famciclovir through various channels:

• Wholesale Distributors: Large pharmaceutical wholesalers secure supply from multiple manufacturers, ensuring broad distribution to hospitals, clinics, and pharmacies.

• Direct Procurement by Governments: In certain markets, government procurement agencies source directly from manufacturers or authorized distributors, focusing on affordability and supply security.

• Pharmaceutical Exporters: Many generic manufacturers export famciclovir to developing nations, emphasizing affordability and accessibility.

Market Dynamics and Regulatory Considerations

Key factors influencing supply include:

• Patent Status: Since famciclovir’s patent expired in many regions (notably in India and other emerging markets), generic production surged, increasing supplier diversity.

• Regulatory Compliance: Suppliers must meet stringent regulatory standards (FDA, EMA, WHO-GMP) to access global markets, particularly developed countries.

• Quality Assurance: Ensuring API purity, bioequivalence, and manufacturing consistency remains critical, influencing manufacturer credibility.

• Supply Chain Disruptions: Geopolitical issues, manufacturing capacity constraints, and global crises like COVID-19 impact supply stability, prompting industry shifts towards diversified sourcing strategies.

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Future Outlook

The supply landscape of famciclovir is expected to remain dynamic, with emerging suppliers entering markets driven by the increasing demand for antivirals. The proliferation of biosimilars and generics in developing markets will likely expand access, albeit with careful oversight to maintain quality standards. Additionally, ongoing investments in API manufacturing facilities in Asia are anticipated to bolster global availability.

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Key Takeaways

• The famciclovir supply chain is diversified, comprising original patent holders, numerous Indian and Chinese generic manufacturers, and contract API suppliers.
• India dominates as a leading producer of generic famciclovir, with companies like Dr. Reddy’s, Aurobindo, and Sun Pharma providing widespread availability.
• Regulatory compliance and manufacturing quality are critical factors influencing supplier credibility and market access.
• Supply stability can be impacted by patent status, geopolitical factors, and global health crises, underscoring the importance of multiple sourcing options.
• Future supply chain resilience hinges on expanding manufacturing capacity, regulatory harmonization, and strategic inventory management.

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FAQs

1. Who are the leading suppliers of famciclovir globally?
Indian companies such as Dr. Reddy’s Labs, Aurobindo Pharma, Sun Pharma, and Hetero Labs dominate the generic famciclovir market. Original patent holders like Novartis supply in select markets.

2. What regions have the most diverse famciclovir supplier options?
South Asia (India and China) offers the largest number of generic producers, ensuring broad access. Developed markets rely more on original formulations and high-quality generics compliant with strict regulations.

3. How do API suppliers influence the global famciclovir supply chain?
API suppliers, especially those in China and India, are vital. Their manufacturing capacity, compliance standards, and export capability directly affect the availability and price stability of famciclovir.

4. Are there risks associated with relying on a limited set of suppliers for famciclovir?
Yes. Over-reliance on a few suppliers can lead to supply disruptions, quality issues, and pricing volatility. Diversification across multiple manufacturers mitigates these risks.

5. What impact does patent expiration have on famciclovir supply?
Patent expiry facilitates increased production by generic manufacturers, expanding supply options and reducing costs. It fosters competition but necessitates stringent quality controls to ensure safety and efficacy.

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References

[1] Novartis Pharma AG. Famvir (Famciclovir). Official Product Documentation.
[2] US Food and Drug Administration (FDA). Approved Drugs Database.
[3] MarketWatch. Generic Pharmaceutical Market Share.
[4] WHO. Guidelines on Good Manufacturing Practices.
[5] International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Global Pharmaceutical Industry Data.