Suppliers and packagers for SIMLIYA

SIMLIYA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	SIMLIYA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	206853	ANDA	Aurobindo Pharma Limited	65862-886-88	3 POUCH in 1 CARTON (65862-886-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-03-22
Aurobindo Pharma	SIMLIYA	desogestrel; ethinyl estradiol	TABLET;ORAL-28	206853	ANDA	Aurobindo Pharma Limited	65862-886-92	6 POUCH in 1 CARTON (65862-886-92) / 1 BLISTER PACK in 1 POUCH (65862-886-28) / 1 KIT in 1 BLISTER PACK	2017-03-22

Suppliers for the Pharmaceutical Drug: SIMLIYA (Remdesivir)

Last updated: August 5, 2025

Introduction

Simliyia, known globally as Remdesivir, is an antiviral medication primarily used to treat COVID-19. It gained prominence during the pandemic as a groundbreaking antiviral therapy. Securing reliable suppliers for Simliyia (Remdesivir) is crucial for healthcare providers, governments, and pharmaceutical companies to ensure steady access and supply chain resilience. This report assesses the primary suppliers, manufacturing landscape, and market dynamics associated with Simliyia.

Overview of Simliyia (Remdesivir)

Developed by Gilead Sciences, Inc., Remdesivir (brand name: Veklury in the U.S. and Simliyia in some markets) was initially investigated for Ebola and other viral infections. It became the first FDA-approved treatment for COVID-19 in October 2020. Its mechanism involves inhibiting the viral RNA-dependent RNA polymerase, disrupting viral replication.

The drug is supplied predominantly through Gilead's manufacturing network, with additional licensed production and distribution channels across the globe. The global demand surge during the pandemic significantly influenced manufacturing and supply chain considerations, leading to collaborations and licensing arrangements to expand access.

Key Suppliers for Simliyia (Remdesivir)

1. Gilead Sciences, Inc.

• Manufacturing Leadership: As the originator, Gilead holds exclusive rights to the production and distribution of Remdesivir.
• Manufacturing Facilities: Gilead operates multiple facilities globally, including sites in the United States (Foster City, California), Ireland, and other locations. These facilities produce Active Pharmaceutical Ingredients (API) and finished drug products.
• Supply Chain and Distribution: Gilead manages global distribution, prioritizing high-demand regions, and partners with various logistics providers to ensure cold chain management. During the pandemic, Gilead scaled up manufacturing capacity significantly, including investing in additional facilities and technology transfers.

2. Contract Manufacturing Organizations (CMOs)

Given Gilead's high demand, strategic partnerships with CMOs have been established:

• Fujifilm Diosynth Biotechnologies: In 2020, Gilead entered into an agreement with Fujifilm to increase API manufacturing capacity, leveraging Fujifilm’s extensive manufacturing capabilities. This partnership aimed to support an increased global supply.
• Hetero Drugs (India): Gilead licensed Hetero to manufacture and distribute Remdesivir in India, Africa, and some other markets. Hetero produces and supplies generic versions and has become a significant supplier in emerging markets.
• Cipla: In India, Cipla was licensed by Gilead to manufacture generic formulations of Remdesivir. Cipla's large-scale manufacturing infrastructure allowed for rapid deployment to India and neighboring regions, addressing local demand.

3. Licensed Generics and Local Suppliers

• Cipla (India): As mentioned, Cipla is among the primary licensed suppliers of generic Remdesivir in India, producing the drug at scale consistent with regulatory standards.
• Hetero: Supplies generics in various territories, especially in African and Asian markets.
• Other licensed generics: Several local pharmaceutical companies across Latin America, Asia, and Africa have obtained licenses from Gilead or its associates or are producing authorized generics to meet local demand.

4. Emerging and Future Suppliers

• Emerging manufacturers: To counteract supply shortages, emerging pharmaceutical companies are seeking licensing agreements or developing their own formulations. Regulatory authorities, such as the EMA and FDA, are facilitating faster approval processes for generic versions.
• Technology transfer and licensing: Gilead has entered into multiple licensing agreements with generic manufacturers under voluntary licensing initiatives, particularly in low- and middle-income countries (LMICs), to expand access.

Market Dynamics and Challenges

The global supply of Simliyia (Remdesivir) has been subject to significant fluctuations due to pandemic pressures, regulatory hurdles, and manufacturing constraints. The surge in demand during 2020-2021 led to shortages, prompting efforts by Gilead and partners to scale manufacturing.

Regulatory Licenses and Patents

Gilead holds patents around the world for Remdesivir, though licensing arrangements have allowed several generic manufacturers to produce the drug in LMICs. The licensing model aims to balance intellectual property rights with public health needs, especially under the auspices of the Medicines Patent Pool (MPP).

Supply Chain Risks and Countermeasures

• Production Bottlenecks: Reliance on limited manufacturing sites presents risks of disruption. Gilead's expansion into multiple geographies mitigates this vulnerability.
• Supply Chain Transparency: Continuous monitoring and strategic stockpiling by governments and agencies help preempt shortages.
• Sustainability Post-Pandemic: The potential for metabolic production of Remdesivir for diseases beyond COVID-19 remains under investigation, influencing future supplier strategies.

Future Outlook

The ongoing demand for COVID-19 treatments and the potential for Remdesivir's application to other viral diseases could sustain or expand the supplier network. Technological advancements and licensing agreements are expected to facilitate broader access, especially in low-resource settings.

Key Takeaways

• Gilead Sciences remains the primary supplier and manufacturer of Simliyia (Remdesivir), leveraging global manufacturing facilities and licensed partnerships.
• Strategic collaborations with CMOs like Fujifilm and licensed manufacturers such as Cipla and Hetero have been instrumental in scaling up supply during the pandemic.
• Licensing agreements under the Medicines Patent Pool and other initiatives facilitate access in emerging markets while protecting Gilead’s patent rights elsewhere.
• Supply chain resilience relies on geographic diversification, technological transfer, and proactive regulatory engagement.
• Market dynamics will evolve depending on the trajectory of COVID-19 variants, broader antiviral development, and regulatory policies on patent protections.

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FAQs

1. Who are the main manufacturers of Simliyia (Remdesivir)?
The primary manufacturer is Gilead Sciences, which produces the active pharmaceutical ingredient (API) and formulates the drug in its own facilities. They collaborate with contract manufacturing organizations like Fujifilm Diosynth Biotechnologies to expand capacity. Licensed generic producers such as Cipla and Hetero also manufacture and distribute Simliyia in specific markets.

2. Are there generic alternatives to Remdesivir?
Yes. Several licensed generic manufacturers, including Cipla and Hetero, produce generic versions of Remdesivir, primarily for distribution in emerging markets. Gilead's licensing agreements, including the Medicines Patent Pool, facilitate these generics' development while maintaining patent protections in higher-income countries.

3. How has Gilead scaled up supply during the COVID-19 pandemic?
Gilead expanded its manufacturing capabilities through direct investment in new facilities, collaborations with CMOs like Fujifilm, and licensing agreements with regional manufacturers. These measures increased global production capacity and addressed regional demand surges.

4. What are the risks associated with the supply chain for Simliyia?
Key risks include dependence on limited manufacturing sites, geopolitical factors, regulatory delays, and raw material shortages. Diversification of manufacturing sources and strategic stockpiling have been employed to mitigate these vulnerabilities.

5. What is the future outlook for Simliyia suppliers?
Continued demand for COVID-19 treatments, potential applications in other viral infections, and expanded licensing programs suggest that the supplier network will remain active. Technological innovations and global health initiatives are likely to further broaden access, especially in LMICs.

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References

[1] Gilead Sciences. “Veklury (Remdesivir) Overview.” Gilead Sciences, 2023.
[2] Medicines Patent Pool. “Remdesivir Licensing Agreements,” 2022.
[3] World Health Organization. “Remdesivir Supply and Access Report,” WHO, 2022.
[4] Hetero Drugs. “Remdesivir Manufacturing and Supply,” Hetero Pharmaceuticals, 2023.
[5] Cipla Ltd. “Remdesivir Product Details,” Cipla, 2023.