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Suppliers and packagers for DOVATO
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DOVATO
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 | DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994 | NDA | ViiV Healthcare Company | 49702-246-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13) | 2019-04-08 |
| Viiv Hlthcare | DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994 | NDA | ViiV Healthcare Company | 49702-246-33 | 1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK | 2019-04-08 |
| Viiv Hlthcare | DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994 | NDA | ViiV Healthcare Company | 49702-246-62 | 1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2019-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dovato
Introduction
Dovato, a groundbreaking antiretroviral medication approved by the U.S. Food and Drug Administration (FDA) in 2019, revolutionized HIV treatment options by combining two potent agents — dolutegravir (DTG) and lamivudine (3TC) — into a single oral tablet. As a fixed-dose combination (FDC), Dovato simplifies therapy, enhances adherence, and addresses the global demand for effective, streamlined HIV regimens. Its commercial success depends heavily on a complex, multi-layered supply chain involving multiple suppliers across various domains, including active pharmaceutical ingredients (APIs), excipients, formulation, packaging, and distribution. This report provides a comprehensive overview of the key suppliers involved in Dovato’s manufacturing ecosystem.
Manufacturing and Supply Chain Overview
The production of Dovato requires seamless coordination between API producers, formulators, and distribution channels. The primary focus lies on the procurement of high-quality APIs for dolutegravir and lamivudine, alongside excipients, packaging materials, and distribution logistics. The complexity of this supply chain is compounded by stringent quality standards, regulatory compliance, and patent considerations.
Active Pharmaceutical Ingredient (API) Suppliers
Dolutegravir API Suppliers
Dolutegravir (DTG), the INSTI class integrase inhibitor at the core of Dovato, is synthesized through complex chemical processes requiring specialized suppliers.
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Viatris (formerly Mylan): Known for manufacturing and supplying generic APIs, Viatris has secured sourcing agreements for dolutegravir. Their manufacturing plants in India and other regions adhere to cGMP standards, ensuring high-quality production suitable for branded formulations.
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Mitsubishi Tanabe Pharma Corporation: Japan-based Mitsubishi supplies dolutegravir APIs to certain pharmaceutical companies for licensed and generic formulations, emphasizing a commitment to quality and regulatory compliance.
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Hetero Labs: An Indian pharmaceutical manufacturer, Hetero, is recognized for its API production capacity for antiretroviral drugs, including dolutegravir, catering to both generic and branded markets.
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Fujifilm Diosynth Biotechnologies: While primarily a biologics manufacturer, Fujifilm has engaged in small-molecule API production collaborations for HIV drugs, including dolutegravir, leveraging their extensive manufacturing expertise.
Lamivudine API Suppliers
Lamivudine (3TC), an NRTI, has been produced by a variety of generic API manufacturers, especially in India and China.
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Sun Pharmaceutical Industries: An Indian pharmaceutical giant producing lamivudine API, with facilities certified under cGMP. Sun Pharma supplies APIs to various companies manufacturing fixed-dose combinations.
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Zhejiang Hisun Pharmaceutical Co., Ltd.: A leading Chinese API producer, supplying lamivudine to various global markets, including formulations used in Dovato.
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Aurobindo Pharma: An Indian API manufacturer offering high-quality lamivudine APIs to the global market, with compliant manufacturing practices.
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Hetero Labs: Also supplies lamivudine API, leveraging a broad manufacturing portfolio and ensuring quality standards compliant with international regulations.
Formulation and Finished Drug Manufacturing
Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource Dovato’s tablet manufacturing to CMOs to manage scale and ensure product consistency.
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Teva Pharmaceutical Industries: Often sources APIs and handles formulation for generic HIV drugs, including fixed-dose combinations, via their manufacturing facilities in Israel and India.
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Cadila Healthcare: An Indian pharmaceutical company involved in contract manufacturing for antiretroviral drugs, capable of producing Dovato tablets under license or agreement.
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Zydus Cadila: Specializes in HIV drugs’ formulation, producing Dovato as part of its portfolio, ensuring adherence to international quality standards.
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United Laboratories (UHT): Filipino manufacturer supplying finished tablets and considering partnerships or licensing agreements for the Dovato formulation.
Active Ingredient & Formulation Quality Control
Manufacturers abide by regulatory standards set by authorities such as the FDA, EMA, and WHO. Their facilities are compliant with cGMP norms, with stringent oversight ensuring product safety, potency, and stability.
Packaging and Distribution
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Packaging Material Suppliers: Suppliers such as WestRock and Amcor provide primary and secondary packaging components, including blister packs, bottles, and labeling materials, adhering to pharmaceutical packaging regulations to prevent tampering and contamination.
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Distribution Partners: Multinational logistics firms like DHL, UPS, and FedEx facilitate global distribution, ensuring timely delivery to health authorities, distributors, clinics, and pharmacies worldwide. These partners maintain cold chain and security protocols to preserve drug integrity.
Regional and Regulatory Considerations
Supply chain security for Dovato involves navigating regional regulations, patent landscapes, and manufacturing licenses. For instance, some generic API producers operate under voluntary licensing arrangements with patent holders like ViiV Healthcare, the originator of Dovato, to ensure compliant manufacturing.
Key Suppliers Summary
| Supplier / Manufacturer | Role | Region | Notes |
|---|---|---|---|
| Viatris | API (Dolutegravir) | Global (India, US) | Leading generic API supplier |
| Mitsubishi Tanabe Pharma | API (Dolutegravir) | Japan | High-quality originator API |
| Hetero Labs | API (Dolutegravir & Lamivudine) | India | Key global supplier |
| Sun Pharma | API (Lamivudine) | India | Major producer for generics |
| Zhejiang Hisun Pharma | API (Lamivudine) | China | Regional and emerging market supplier |
| Aurobindo Pharma | API (Lamivudine) | India | Extensive manufacturing network |
| Teva Pharmaceutical | Formulation & Distribution | Israel, India | Large-scale manufacturer |
| Zydus Cadila | Formulation | India | Noted for HIV fixed-dose combos |
| WestRock / Amcor | Packaging | Global | Reliable packaging solutions |
Conclusion
The supply chain for Dovato demonstrates a tightly integrated network of dominant API producers, formulation specialists, packaging providers, and logistics firms. The reliance on Indian and Chinese manufacturers underscores the importance of quality compliance and regulatory oversight. The continued stability of this network hinges on patent protections, supply chain resilience, and adherence to international quality standards.
Key Takeaways
- Global API sourcing is vital for Dovato’s production; Indian and Chinese manufacturers dominate due to capacity and cost-efficiency.
- Regulatory compliance remains paramount, with all suppliers adhering to cGMP standards to meet global approval requirements.
- Supply chain diversification mitigates risks associated with geopolitical tensions, pandemics, or manufacturing disruptions.
- Partnerships with CMOs optimize manufacturing scalability and ensure quality consistency for finished Dovato tablets.
- Strategic inventory management and logistics are critical in maintaining uninterrupted supply, particularly for high-demand global markets.
FAQs
1. What are the primary regions supplying APIs for Dovato?
India and China are the main regions providing APIs for dolutegravir and lamivudine, due to their extensive manufacturing capacities and cost advantages.
2. How does patent law influence Dovato’s supply chain?
Patent protections, primarily held by ViiV Healthcare, impact generic manufacturing. Licensing agreements ensure suppliers produce compliant APIs without infringing patents.
3. Are there alternative suppliers for Dovato’s APIs?
Yes, several global and regional producers can supply APIs, but the choice depends on regulatory approval, quality certifications, and supply reliability.
4. What advancements are influencing Dovato’s supply chain?
Automation, quality control technologies, and supply chain digitization improve transparency, traceability, and responsiveness, reducing delays.
5. How does supply chain security affect Dovato’s market availability?
Robust supplier relationships and diversified sources ensure consistent supply, safeguarding Dovato’s availability amid global disruptions.
Sources:
[1] ViiV Healthcare. Dovato Prescribing Information. 2022.
[2] U.S. Food and Drug Administration. FDA Approval Package for Dovato. 2019.
[3] IQVIA. Global API Market Report. 2022.
[4] Indian Pharmaceutical Industry Statistics. Pharmapproach.com. 2022.
[5] World Health Organization. Essential Medicines List. 2022.
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