Suppliers and packagers for TIVICAY PD

TIVICAY PD

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983	NDA	ViiV Healthcare Company	49702-255-37	1 BOTTLE in 1 CARTON (49702-255-37) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE	2020-06-12

Suppliers for the Pharmaceutical Drug: TIVICAY PD

Last updated: July 31, 2025

Introduction

TIVICAY PD (dolutegravir, active pharmaceutical ingredient—API) is an antiretroviral drug primarily used in the treatment of HIV-1 infection. As a key component of combination therapies, TIVICAY PD is integral in managing HIV infectious diseases worldwide. The supply chain for TIVICAY PD involves multiple suppliers providing raw materials, active pharmaceutical ingredients, and finished products, with various companies operating globally to meet the increasing demand. This analysis clarifies the key suppliers involved in the TIVICAY PD production chain, focusing on API manufacturing, excipient sourcing, and formulation processes.

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Manufacturers of Dolutegravir API

1. GlaxoSmithKline (GSK)

As the originator of TIVICAY (dolutegravir), GSK maintains a significant share of the API manufacturing process. GSK’s manufacturing facilities span across multiple countries, including the UK and other locations, ensuring supply security for its pharmaceutical products. GSK's API production adheres to stringent Good Manufacturing Practices (GMP), ensuring quality and consistency.

2. Novartis

Although Novartis does not hold the patent for dolutegravir, historical collaborations and manufacturing alliances have facilitated API production in the broader antiretroviral drugs landscape. Novartis's manufacturing sites in India and Switzerland have the capacity for complex API synthesis, including integrase inhibitors such as dolutegravir.

3. Mylan (now part of Viatris)

Viatris, through its acquisition of Mylan, sources dolutegravir API from third-party suppliers or potentially manufacturing in-house. Mylan has historically been involved in generic versions of HIV medications, making it a supplier or producer of dolutegravir API for specific markets.

4. Other Contract Manufacturing Organizations (CMOs)

Beyond the major pharmaceutical companies, several CMOs specialize in the synthesis and supply of dolutegravir API. These include firms in India and China that have obtained technology licenses or produce APIs under stringent quality controls. Notable companies include:

• Hetero Labs (India)
• Aurobindo Pharma (India)
• Zhejiang Hisun Pharmaceutical (China)

These firms often engage in contract manufacturing for larger pharmaceutical companies, providing API at competitive costs.

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Excipient and Formulation Ingredient Suppliers

TIVICAY PD tablets include various excipients such as binders, fillers, disintegrants, and coatings supplied by established excipient manufacturers. Prominent suppliers include:

• FMC Corporation – supplies binders and fillers such as microcrystalline cellulose.
• Dow Chemical – supplies coating agents and disintegrants.
• JRS Pharma – supplies specialty excipients for sustained-release formulations.

The choice of excipients ensures optimal drug stability, bioavailability, and manufacturing consistency.

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Finished Pharmaceutical Product (FPP) Manufacturers

While GSK produces TIVICAY tablets, several generic manufacturers worldwide source API from third-party suppliers and develop their own formulations. Some key manufacturers of TIVICAY FPP include:

• GSK (United Kingdom) – Original patent holder manufacturing for global markets.
• Viatris (multiple countries) – Produces generic versions for regions where patent protections have expired.
• Sandoz (Germany) – Engages in generic manufacturing through licensing agreements.

In emerging markets, local pharmaceutical companies frequently partner with API suppliers for regional distribution, often utilizing licensed APIs from Indian or Chinese manufacturers.

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Regulatory and Quality Considerations

Suppliers for TIVICAY PD must comply with strict international standards, including:

• Global GMP compliance (ICH Q7 guidelines),
• FDA approval for APIs intended for US markets,
• EMA standards for European Union markets.

Manufacturers with approved facilities and validated processes are prioritized to ensure the security of supply and quality assurance.

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Market Dynamics and Supply Chain Risks

The global supply chain for TIVICAY PD is subject to geopolitical, economic, and regulatory risks. Dependency on a limited number of API suppliers can impact availability and pricing. Recent shifts in manufacturing, notably in India and China, have made regional diversification crucial. Additionally, patent statuses influence manufacturing rights, with generic producers expanding their source bases once patent exclusivity lapses.

GSK has proactively managed its supply chain through licensing agreements, establishing backup manufacturing partners, and expanding its API production capacity to meet the international demand surge.

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Emerging Trends in TIVICAY PD Supply

• Increased licensing and technology transfer agreements: To diversify API sourcing and prevent supply bottlenecks.
• Use of Contract Manufacturing Organizations (CMOs): To supplement in-house capacity and ensure capacity expansion.
• Vertical integration: Some originators are investing directly in API manufacturing facilities to secure supplies.

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Key Takeaways

• Major API suppliers: GSK remains the principal manufacturer of dolutegravir API, supplemented by CMOs across India and China.
• Generic manufacturers: They often rely on licensed APIs from Indian and Chinese suppliers post-patent expiry.
• Quality assurance: Suppliers must adhere to GMP and international regulatory standards to meet global demand.
• Supply chain risks: Overdependence on a limited supplier base could pose challenges; diversification strategies are critical.
• Industry trends: Increasing licensing agreements promote supply stability and cost containment.

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FAQs

1. Who are the primary API suppliers for TIVICAY PD?
The main API provider is GlaxoSmithKline, with additional supplies from Indian firms like Hetero Labs, Aurobindo Pharma, and Chinese manufacturers such as Zhejiang Hisun Pharmaceutical.

2. What regulatory standards do TIVICAY PD suppliers need to meet?
Suppliers must comply with GMP standards outlined by ICH guidelines, EMA, and FDA, ensuring product quality, safety, and efficacy.

3. Are there alternative sources for dolutegravir API?
Yes, licensed generic APIs are sourced from Indian and Chinese manufacturers, especially post-patent expiry, to meet global demand.

4. How does supply chain risk impact TIVICAY PD availability?
Dependence on limited suppliers increases risk; geopolitical issues, manufacturing disruptions, or regulatory changes can affect supply continuity.

5. What trends are shaping the future of TIVICAY PD supply?
Growing licensing deals, increased use of CMOs, and strategic investments in API production capacity aim to enhance supply security.

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References

1. GlaxoSmithKline. TIVICAY (dolutegravir) Product Information. GSK, 2022.
2. World Health Organization. Model List of Essential Medicines, 2022.
3. U.S. Food and Drug Administration. API Manufacturing Compliance Guidelines, 2021.
4. Indian Pharmaceutical Industry Reports. Indian API Manufacturers, 2022.
5. Chinese Pharmaceutical Industry Analysis. Zhejiang Hisun Pharmaceutical, 2022.

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In conclusion, the supply ecosystem for TIVICAY PD revolves around a combination of proprietary manufacturing by GSK and a robust network of licensed and contract API manufacturers primarily based in India and China. Ensuring quality, regulatory compliance, and diversification remains critical for maintaining consistent availability of this essential HIV medication worldwide.