Suppliers and packagers for tivicay

tivicay

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	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-226-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)	2016-06-09
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-227-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)	2016-06-09
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790	NDA	ViiV Healthcare Company	49702-228-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-228-13)	2013-08-13

Last updated: August 5, 2025

ppliers for the Pharmaceutical Drug: TIVICAY

Introduction
TIVICAY (dolutegravir) is a widely prescribed antiretroviral medication developed by ViiV Healthcare, primarily used in the treatment of HIV-1 infection. Its effectiveness, safety profile, and ease of administration have made it a globally preferred choice within HIV management protocols. As demand for TIVICAY increases owing to the global HIV epidemic, understanding the landscape of its suppliers becomes crucial for manufacturers, healthcare providers, and investors. This article provides an authoritative overview of the key suppliers involved in the production and distribution of TIVICAY, analyzing manufacturing capacities, supply chain dynamics, and implications for market stability.

Manufacturing and Supply Chain Overview
TIVICAY's active pharmaceutical ingredient (API), dolutegravir, is a complex molecule requiring sophisticated synthesis processes. Its supply chain is geographically diverse, involving multiple tiers of suppliers—from raw material producers to advanced active ingredient suppliers and finished-dose manufacturers. ViiV Healthcare, as the originator, relies on a network of licensed and contract manufacturing organizations (CMOs) across several countries.

The API itself is produced through intricate chemical synthesis, with key intermediates and raw materials sourced from specialized suppliers globally. The manufacturing process demands high-quality standards, strict regulatory compliance, and capacity expansion to meet increasing global demand.

Key Suppliers of Dolutegravir API

1. Hetero Labs (India)
   Hetero Labs is a prominent chemical and pharmaceutical manufacturer based in Hyderabad, India. It gained approval to produce dolutegravir API, leveraging its extensive experience in generic antiretroviral drugs. Hetero's integration into the supply chain was reinforced around 2017-2018 as part of initiatives to expand access in low- and middle-income countries (LMICs). The company's capacity is estimated to be in the several hundred kilograms per month range, sufficient to support generic formulations in many regions.

2. Mylan (now part of Viatris)
   Mylan, prior to its merger with Pfizer's Upjohn division, was an approved API manufacturer for dolutegravir in India. Post-merger, Viatris continues to produce APIs, including those for HIV treatments, across multiple facilities with validated quality standards. Mylan's manufacturing facilities in India and the Czech Republic have supplied API for both generic and branded formulations, including TIVICAY.

3. VTR BioPharma and Macleods Pharmaceuticals
   These Indian companies have expanded their API production capabilities, often through licensing agreements with the originator or via vertical integration strategies. Macleods, in particular, has invested heavily in capacity enhancement to meet the burgeoning demand for antiretrovirals.

4. Roche and other multinational raw material suppliers
   While Roche and other large pharmaceutical multinationals typically do not produce dolutegravir API themselves, they supply high-quality raw materials or intermediates used by primary API manufacturers. Their role is pivotal in ensuring the supply chain's robustness, especially given the complex synthesis routes involved.

Finished-Dose Manufacturing
Once API production is secured, formulation and filling are performed by a network of CMOs across various regions, including India, Europe, and North America. ViiV Healthcare maintains strict quality oversight, with licensed facilities in the United States, the European Union, and emerging markets.

Geographical Dynamics and Supply Risks
The geopolitical landscape influences supply stability. For example, India remains the primary manufacturing hub for generic antiretrovirals owing to cost advantages and regulatory pathways. However, recent shifts towards diversification include European and North American investments to mitigate risks associated with regional disruptions (e.g., customs delays, political tensions).

In 2021, ViiV announced capacity expansion plans to support global HIV eradication goals, including increasing API production at Hetero and Macleods. Nevertheless, supply constraints, especially in raw materials sourced from Asia, pose persistent risks. The ongoing impact of COVID-19 has exacerbated manufacturing delays, underscoring the importance of a diversified supplier network.

Regulatory and Quality Control Considerations
Suppliers must adhere to stringent standards, including WHO prequalification, US FDA acceptance, and EMA approval. These certifications facilitate global distribution, especially in LMICs. Disruptions in regulatory approvals or non-compliance have historically caused periodic shortages, emphasizing the critical role of quality-assured suppliers aligned with international standards.

Emerging Trends and Future Outlook

• Vertical Integration: Increasing capacity in API production and formulation manufacturing by both originators and generic players to meet rising demand.
• Regional Diversification: Distributing manufacturing capacity across regions to buffer geopolitical and supply chain risks.
• Sustainable Sourcing: Emphasizing environmentally responsible raw material procurement aligned with evolving regulations and market expectations.
• Innovation and Biosimilar Development: Exploring longer-acting formulations and injectable options, which may involve new suppliers and manufacturing paradigms.

Conclusion
The supply landscape for TIVICAY involves several key players, predominantly situated within India, with supporting manufacturers across Europe and North America. Hetero Labs, Macleods Pharmaceuticals, and Viatris are among the primary suppliers of dolutegravir API, supporting both generic and branded formulations. Supply chain resilience hinges on diversified sourcing, high regulatory compliance, and capacity expansion aligned with global demand trends. As the market for HIV therapy evolves, continuous supplier capacity enhancement and risk mitigation strategies will be vital for ensuring uninterrupted access to TIVICAY worldwide.

---

Key Takeaways

• The primary API suppliers for TIVICAY are Hetero Labs, Macleods Pharmaceuticals, and Viatris, with manufacturing concentrated mainly in India.
• Diversification of manufacturing regions and capacity expansion are central to mitigating supply risks amid geopolitical and pandemic-related disruptions.
• Strict adherence to international regulatory standards is essential for supplier credibility and global distribution, especially in LMICs.
• Ongoing capacity investments signal sustained demand growth, emphasizing the importance of proactive supply chain management.
• Emerging innovations in formulation and manufacturing may introduce new supplier opportunities, further stabilizing future supply chains.

---

FAQs

1. Who are the main API suppliers for TIVICAY?
Hetero Labs, Macleods Pharmaceuticals, and Viatris are the primary API suppliers for dolutegravir used in TIVICAY, primarily based in India, with additional capacity in Europe and North America.

2. How does supply chain diversification impact TIVICAY availability?
Diversification reduces dependency on single sources or regions, minimizing risks from geopolitical instability, manufacturing delays, or raw material shortages, thus enhancing supply continuity.

3. What regulatory standards do suppliers for TIVICAY need to meet?
Suppliers must comply with WHO prequalification standards, US FDA approvals, EMA certification, and other regional regulatory requirements to ensure safety and efficacy.

4. Are there any recent supply shortages of TIVICAY?
While generally stable, periodic shortages have occurred due to pandemic-related disruptions, raw material access issues, or regulatory delays in certain regions. Capacity expansions aim to address these concerns.

5. What emerging trends could influence future TIVICAY supply?
Increased capacity investments, regional manufacturing diversification, sustainable sourcing practices, and innovations in formulation are shaping a resilient supply landscape for TIVICAY.

---

References

1. ViiV Healthcare. (2022). TIVICAY (dolutegravir) product information.
2. Global Market Insights. (2022). Antiretroviral drug manufacturing landscape report.
3. WHO Prequalification of Medicines Program. (2023). List of approved API manufacturers.
4. Indian Pharmaceutical Alliance. (2023). API manufacturing capacity and regional dynamics.
5. Industry analysis reports. (2022). Trends in HIV antiretroviral commodity supply chains.