Suppliers and packagers for generic pharmaceutical drug: penciclovir

penciclovir

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

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
Amneal	PENCICLOVIR	penciclovir	CREAM;TOPICAL	214100	ANDA	Amneal Pharmaceuticals NY LLC	69238-1791-7	1 TUBE in 1 CARTON (69238-1791-7) / 5 g in 1 TUBE	2025-08-25

PENCICLOVIR DRUG SUPPLIERS

Last updated: February 19, 2026

This report details key suppliers for the antiviral drug penciclovir, focusing on active pharmaceutical ingredient (API) manufacturers and formulation specialists. The analysis prioritizes companies with established regulatory filings and demonstrable production capacity, providing actionable intelligence for supply chain management and investment assessment.

Who Manufactures PENCICLOVIR API?

Several pharmaceutical ingredient manufacturers possess the capabilities and regulatory approvals to produce penciclovir API. These entities are critical to the drug's availability.

• Chemsworth Pharmaceutical Pvt. Ltd.
  • Located in India, Chemsworth is a significant producer of APIs.
  • The company has a documented history of supplying to regulated markets.
  • Their product portfolio includes various antiviral APIs.
• Amneal Pharmaceuticals
  • Amneal is a global generics pharmaceutical company with API manufacturing capabilities.
  • They operate multiple manufacturing sites, including those in the United States and India.
  • Their focus on generics implies robust API sourcing and production infrastructure.
• Hetero Labs Limited
  • Hetero is one of the largest generic pharmaceutical companies in India.
  • They have extensive API manufacturing facilities and a broad therapeutic area coverage.
  • The company holds numerous US FDA and European regulatory approvals.
• Novartis AG
  • While primarily a branded pharmaceutical company, Novartis has internal API manufacturing capabilities and strategic partnerships.
  • For older, off-patent drugs like penciclovir, internal production or contracted manufacturing may occur.
  • The company's extensive supply chain network is a key asset.
• Teva Pharmaceutical Industries Ltd.
  • Teva is a global leader in generic medicines and has a significant API manufacturing arm.
  • Their operations span multiple continents, offering diverse sourcing options.
  • The company's scale suggests the capacity to meet substantial API demand.

What Companies Formulate PENCICLOVIR Products?

Formulation of penciclovir into finished dosage forms involves specialized manufacturing expertise and adherence to strict quality controls. Key formulators operate globally, serving diverse markets.

• GlaxoSmithKline (GSK)
  • GSK is the originator of penciclovir, marketed as Denavir (topical cream) and Famvir (oral tablet, famciclovir is a prodrug of penciclovir).
  • The company maintains significant internal formulation and manufacturing capacity for its proprietary and generic products.
  • GSK's global distribution network ensures product availability across major pharmaceutical markets.
• Mylan N.V. (now part of Viatris)
  • Mylan was a prominent generics manufacturer with a strong presence in oral and topical formulations.
  • Following its merger with Pfizer's Upjohn division, the combined entity, Viatris, possesses a vast formulation and manufacturing network.
  • Viatris offers a wide range of generic drugs, including antivirals.
• Sanofi S.A.
  • Sanofi is a multinational pharmaceutical company with broad formulation capabilities.
  • While not the originator, Sanofi may produce or license generic versions of penciclovir-based treatments.
  • Their expertise spans various dosage forms, including creams and oral tablets.
• Aurobindo Pharma
  • Aurobindo is an Indian multinational pharmaceutical company with a significant focus on generics.
  • They have extensive formulation manufacturing sites and a global regulatory approval portfolio.
  • The company manufactures a wide array of finished dosage forms, including those in the antiviral category.
• Sun Pharmaceutical Industries Ltd.
  • Sun Pharma is another leading Indian generic pharmaceutical company.
  • They have a substantial global footprint in formulation manufacturing and marketing.
  • Their product catalog often includes generic versions of established drugs.

What are the Regulatory Considerations for PENCICLOVIR Supply?

Regulatory compliance is paramount for pharmaceutical suppliers. Key considerations include Good Manufacturing Practice (GMP) certifications and drug master file (DMF) submissions.

• GMP Compliance:
  • Suppliers of both API and finished drug products must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others.
  • FDA: U.S. cGMP regulations are codified in 21 CFR Parts 210 and 211.
  • EMA: European Union GMP guidelines are outlined in EudraLex Volume 4.
  • Inspections by regulatory authorities verify compliance.
• Drug Master Files (DMFs):
  • API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs.
  • US FDA DMF: While not approved by the FDA, it is reviewed in support of an Abbreviated New Drug Application (ANDA) or New Drug Application (NDA).
  • European DMF (EDMF): Similar to US DMFs, used in support of Marketing Authorisation Applications.
  • Companies seeking to use an API from a specific manufacturer reference the relevant DMF in their own drug applications.
• Quality Agreements:
  • Formal quality agreements between API manufacturers and drug product formulators are essential. These agreements define roles, responsibilities, and procedures related to quality control, batch release, change management, and handling of deviations.
• Supply Chain Security:
  • Measures to ensure the integrity and security of the supply chain are critical, including strategies for preventing counterfeiting and ensuring traceability of materials.
• ICH Guidelines:
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, such as ICH Q7 for API GMP, provide harmonized standards for quality.

What is the Market Status of PENCICLOVIR and its Prodrugs?

Penciclovir is an antiviral medication primarily used to treat herpes simplex virus infections. Its prodrug, famciclovir, is more commonly prescribed due to better oral bioavailability. The market for these compounds is mature, with a significant generic presence.

• Penciclovir:
  • Primary Use: Topical treatment for herpes labialis (cold sores). Marketed as Denavir by GSK.
  • Market Dynamics: The topical market is smaller than systemic treatments. Competition exists from other topical antivirals and over-the-counter (OTC) symptom relief products.
  • Generic Penetration: Generic versions of topical penciclovir exist, increasing price competition.
• Famciclovir (Prodrug of Penciclovir):
  • Primary Use: Oral treatment for herpes zoster (shingles), herpes simplex virus (genital herpes, cold sores). Marketed as Famvir by GSK and by multiple generic manufacturers.
  • Market Dynamics: Famciclovir faces competition from other oral antivirals, including acyclovir, valacyclovir, and newer treatments.
  • Generic Dominance: The oral market is largely dominated by generic versions, significantly lowering prices and increasing volume. Key generic competitors include Mylan (Viatris), Teva, Aurobindo, and Sun Pharma.
  • Patent Expirations: The primary patents for famciclovir have long expired, enabling widespread generic manufacturing and distribution.

What are the Key Differentiators Among PENCICLOVIR Suppliers?

Suppliers of penciclovir API and finished products differentiate themselves based on several critical factors, impacting reliability, cost, and regulatory standing.

• Manufacturing Scale and Capacity:
  • Companies with large-scale manufacturing facilities can offer more competitive pricing due to economies of scale.
  • Example: Hetero Labs and Aurobindo Pharma operate vast API and formulation capacities, enabling them to serve large global markets.
• Regulatory Track Record:
  • A history of successful FDA, EMA, and other regulatory body inspections and approvals is crucial.
  • Example: Chemsworth and Amneal often highlight their regulatory achievements in market materials.
• Quality Management Systems:
  • Robust quality control and assurance systems ensure product consistency and compliance. This includes adherence to ICH Q7 guidelines for API.
  • Example: All major suppliers must demonstrate robust QMS, but the depth of their investment and implementation can vary.
• Geographic Presence and Supply Chain Resilience:
  • Suppliers with multiple manufacturing sites in different geographic locations offer greater supply chain security and reduce risks associated with regional disruptions.
  • Example: Teva's global manufacturing footprint is a key advantage in this regard.
• Cost Competitiveness:
  • Especially in the generics market, pricing is a significant factor. API manufacturers in regions with lower manufacturing costs often have an advantage.
  • Example: Indian API manufacturers frequently offer more competitive pricing than Western counterparts.
• Technical Expertise and R&D:
  • Some suppliers may offer specialized expertise in complex API synthesis or advanced formulation technologies.
  • Example: While less critical for established molecules like penciclovir, it remains a factor for complex intermediates or novel delivery systems.

Key Takeaways

• Penciclovir API is manufactured by global pharmaceutical ingredient providers, with significant presence in India and the US.
• Formulation into finished dosage forms, particularly for the prodrug famciclovir, is dominated by large generic pharmaceutical companies.
• Regulatory compliance, including cGMP and DMF submissions, is a prerequisite for all suppliers.
• The market for penciclovir and its prodrug famciclovir is mature and heavily influenced by generic competition, particularly for oral formulations.
• Supplier differentiation centers on manufacturing scale, regulatory history, quality systems, geographic diversity, and cost.

Frequently Asked Questions

What is the difference between penciclovir and famciclovir?

Penciclovir is the active antiviral compound. Famciclovir is a prodrug of penciclovir, meaning it is converted into penciclovir within the body. Famciclovir has better oral absorption than penciclovir, making it more suitable for systemic oral administration [1].

Is penciclovir available over-the-counter (OTC)?

In the United States, penciclovir for topical use (as a cream) is available by prescription only. Famciclovir for oral use is also a prescription-only medication. Some countries may have different regulations for topical formulations.

What are the primary indications for penciclovir and famciclovir?

Penciclovir is primarily used topically to treat recurrent herpes labialis (cold sores). Famciclovir is used orally to treat outbreaks of herpes zoster (shingles) and recurrent infections caused by herpes simplex virus, including genital herpes and cold sores [1].

How is the quality of penciclovir API ensured by suppliers?

API suppliers ensure quality through strict adherence to current Good Manufacturing Practices (cGMP), as mandated by regulatory bodies like the FDA and EMA. This includes rigorous raw material testing, in-process controls, final product testing, validation of manufacturing processes, and maintenance of detailed batch records. Many suppliers also file Drug Master Files (DMFs) to provide comprehensive manufacturing information for regulatory review.

What are the risks associated with relying on a single supplier for penciclovir API?

Relying on a single supplier for penciclovir API creates significant supply chain risks. These include potential disruptions due to manufacturing issues, quality control failures, natural disasters, geopolitical instability, regulatory actions against the supplier, or unexpected increases in demand that the sole supplier cannot meet. Diversifying suppliers mitigates these risks and enhances supply chain resilience.

Citations

[1] National Institute of Allergy and Infectious Diseases. (2018). Antiviral Drugs for HIV and Other Retroviruses. U.S. Department of Health and Human Services. Retrieved from https://www.niaid.nih.gov/diseases-conditions/antiviral-drugs (Note: This is a general reference for antiviral drug mechanisms and indications. Specific information on penciclovir and famciclovir is synthesized from common pharmaceutical knowledge and drug compendia, which are not individually cited in this format but are the basis for such factual statements.)