Suppliers and packagers for valtrex

valtrex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487	NDA	GlaxoSmithKline LLC	0173-0565-04	30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)	2002-08-12
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487	NDA	GlaxoSmithKline LLC	0173-0565-10	90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)	2002-08-12
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487	NDA	GlaxoSmithKline LLC	0173-0933-08	30 TABLET, FILM COATED in 1 BOTTLE (0173-0933-08)	1995-08-01

Suppliers for the Pharmaceutical Drug: VALTREX

Last updated: August 1, 2025

Introduction

Valtrex (generic name: valacyclovir) is an antiviral medication widely prescribed for herpes virus infections, including herpes zoster (shingles), genital herpes, and cold sores. As a prodrug of acyclovir, Valtrex offers increased bioavailability compared to its predecessor, making it a preferred option for clinicians. Given its significant market demand, understanding the landscape of suppliers—manufacturers, generic entrants, and authorized distributors—is critical for stakeholders, including healthcare providers, pharmaceutical companies, and investors. This article provides a comprehensive analysis of current suppliers for Valtrex, covering brand and generic manufacturers, supply chain dynamics, and market trends.

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Overview of Valtrex Manufacturing and Approvals

Valtrex was developed by GlaxoSmithKline (GSK), which holds the original patent and marketing authorization. In 2009, the patent expired in many jurisdictions, prompting numerous generic manufacturers to enter the market. The drug’s manufacturing process involves complex chemical synthesis and stringent quality controls, particularly given its antiviral application, necessitating high standards compliant with regulatory agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other national authorities.

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Major Suppliers of Valtrex: Brand and Patent Holders

GlaxoSmithKline (GSK)

GSK remains a key supplier under the Valtrex brand. Although patent protection has expired in many regions, GSK retains a significant market share through existing stock and authorized generics, pending patent litigation or exclusivity agreements. GSK’s global production facilities adhere to cGMP (current Good Manufacturing Practice) standards, ensuring supply reliability across primary markets such as the United States, Europe, and Asia.

Other Brand Manufacturers and Authorized Generics

In markets where patent protection has lapsed, GSK’s authorized generics—licensed versions produced under the original patent holder’s license—continue to dominate distribution channels. These are typically sold through GSK’s controlled distribution network or licensed third parties.

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Generic Manufacturers of Valacyclovir

Following patent expiration, the market saw rapid entry by a multitude of generic drug manufacturers. These entities supply cost-effective alternatives, significantly impacting pricing and availability globally.

Key Global Generic Suppliers

1. Teva Pharmaceutical Industries Ltd.
   As one of the world's largest generic manufacturers, Teva produces valacyclovir under various formulations. They operate manufacturing plants compliant with international standards, ensuring broad distribution channels across North America, Europe, and emerging markets.

2. Hetero Drugs Ltd.
   An Indian pharmaceutical company with substantial expertise in antiviral generics, Hetero supplies valacyclovir to multiple markets. They possess WHO-GMP-certified plants and have received approvals from major regulatory bodies, including the USFDA.

3. Mylan (now part of Viatris)
   Mylan has been pivotal in expanding access to affordable antivirals. Their valacyclovir production caters to healthcare systems seeking budget-conscious options, with manufacturing facilities in India and the US.

4. Sun Pharmaceutical Industries Ltd.
   As a leading Indian generic manufacturer, Sun Pharma supplies valacyclovir formulations across numerous territories, with extensive regulatory approvals and robust distribution networks.

5. Sandoz (Novartis)
   Sandoz maintains a significant portfolio of generics, including valacyclovir, supporting markets in Europe, North America, and globally through their strategic partnerships.

6. Zydus Cadila
   An Indian firm with a growing footprint, Zydus provides affordable antiviral generics, including valacyclovir, with certifications from the USFDA and other agencies.

7. Glenmark Pharmaceuticals
   Headquartered in India, Glenmark’s antiviral generics are marketed in multiple regions, supported by their integrated R&D and manufacturing capabilities.

Regional and Emerging Market Suppliers

In addition to these global players, numerous regional manufacturers in countries such as China, South Korea, and Latin America supply generic valacyclovir, often under local or regional marketing authorizations. These suppliers bolster the global supply chain, particularly where price sensitivity dictates preference for locally produced generics.

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Supply Chain and Market Dynamics

Regulatory Approvals and Patent Disputes

While patent protection has largely expired, the landscape remains complex due to patent litigations and secondary patents. GSK, the original patent holder, has historically engaged in patent litigation to delay generic entry in major markets, especially the US and EU. Once patents expire, generic manufacturers quickly enter, leading to price reductions and increased supply.

Manufacturing Challenges and Quality Assurance

High-quality manufacturing is critical for antivirals due to their stringent regulatory environments and the need for reliable supply. Manufacturers must comply with cGMP standards, undergo regular inspections, and maintain consistent potency and purity levels for their products.

Global Supply and Access

Emerging markets often depend on Indian and Chinese manufacturers for affordable valacyclovir. These regions have experienced rapid growth in antiviral generic supplies, driven by government procurement policies and public health needs. However, supply disruptions can occur due to production issues, regulatory delays, or geopolitical factors.

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Market Trends and Future Outlook

Shift Toward Biosimilars and New Antiviral Therapies

While traditional small-molecule antivirals like valacyclovir dominate current markets, ongoing innovation includes biosimilars and novel agents aimed at improving efficacy and reducing resistance. However, valacyclovir remains the cornerstone antiviral for herpes management due to its proven efficacy and safety profile.

Consolidation and Partnerships

The antiviral market is witnessing increased partnerships between brand owners and generic manufacturers. For example, licensing agreements facilitate faster market entry and ensure quality compliance, as seen in recent collaborations involving major Indian producers.

Impact of Regulatory Changes

Stricter regulatory standards globally influence supply stability. Manufacturers investing in robust compliance systems are better positioned to expand or maintain their market share, especially as regulators prioritize drug quality and supply security.

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Key Takeaways

• Primary suppliers include GSK (brand and authorized generics), with a broad array of generic producers such as Teva, Mylan/Viatris, Hetero, Sun Pharma, and Sandoz dominating the global landscape.

• Post-patent expiration, a surge in generic manufacturing has driven down prices, expanding access in developing markets.

• Regulatory compliance remains fundamental; quality standards and patent disputes influence supply timelines and market dynamics.

• Regional manufacturers play an essential role in ensuring supply chain resilience, particularly in emerging markets, but face challenges with regulatory approvals and quality assurance.

• Future focus will likely involve continued generic competition, strategic partnerships, and potential innovations that could affect global supply flows.

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FAQs

1. Who are the leading global suppliers of valacyclovir?
Teva, Mylan (Viatris), Sandoz, Hetero Drugs, and Sun Pharma are among the top global manufacturers of valacyclovir, providing both branded and generic formulations across major markets.

2. How has patent expiration impacted the supply of Valtrex?
Patent expiry has facilitated the entry of numerous generic manufacturers, increasing supply availability, reducing prices, and expanding access, especially in developing regions.

3. Are there quality concerns with generic valacyclovir?
Top generic manufacturers adhere to strict manufacturing quality standards set by regulatory agencies such as the USFDA and EMA, ensuring comparable efficacy and safety to branded versions.

4. What challenges do suppliers face in the supply chain?
Manufacturing capacity constraints, regulatory approval delays, patent litigations, and geopolitical factors can disrupt or delay supply.

5. Will brand-name Valtrex remain relevant in the future?
While generics dominate due to affordability, brand-name Valtrex maintains market presence through trusted quality, especially in regions with strict regulations or where patent protections are still in effect.

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References

[1] U.S. Food and Drug Administration. (2021). Generic Drugs: Questions & Answers.
[2] GlobalData Healthcare. (2022). Market Analysis of Antiviral Drugs.
[3] IQVIA Institute. (2022). The Global Use of Medicines in 2022.
[4] Indian Pharmaceutical Association. (2020). Overview of Indian Generic Drug Manufacturers.
[5] European Medicines Agency. (2022). Marketing Authorizations for Valacyclovir.