Suppliers and packagers for descovy

descovy

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1)	2016-04-04
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2002-2	30 TABLET in 1 BLISTER PACK (61958-2002-2)	2016-04-04
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215	NDA	Gilead Sciences, Inc.	61958-2005-1	30 TABLET in 1 BOTTLE, PLASTIC (61958-2005-1)	2022-01-07

Suppliers for the Pharmaceutical Drug: DESCOVY

Last updated: July 29, 2025

Introduction

Descovy, a well-established antiretroviral medication developed by Gilead Sciences, Inc., serves as a vital component in HIV-1 treatment and prevention. The drug’s efficacy and safety profile have made it a preferred choice for clinicians worldwide. Central to Descovy’s availability are its suppliers—entities responsible for manufacturing, sourcing ingredients, and ensuring quality control. Understanding the supplier landscape for Descovy provides pharmaceutical professionals, investors, and healthcare policymakers critical insights into supply chain robustness, potential risks, and opportunities for strategic procurement.

Manufacturing and Supply Chain Overview of Descovy

Descovy is a fixed-dose combination (FDC) comprising tenofovir alafenamide (TAF) and emtricitabine, both antiretroviral agents. Gilead holds exclusive rights over the formulation, manufacturing, and distribution of Descovy, contracting both in-house manufacturing facilities and external suppliers to meet global demand. The supply chain intricacies encompass sourcing raw materials, active pharmaceutical ingredients (APIs), formulation, packaging, and distribution networks.

Active Pharmaceutical Ingredient (API) Suppliers

The core constituents of Descovy are TAF and emtricitabine. Gilead Sciences predominantly manufactures these APIs internally but sourcing from specialized external suppliers is also common to diversify risks.

• Tenofovir Alafenamide (TAF) API Suppliers

  Gilead procures TAF from several key API manufacturers, including [1]:

  • Jiangsu Hengrui Medicine Co., Ltd. (China): Known for advanced nucleoside reverse transcriptase inhibitors (NRTIs) production.

  • Cipla Ltd. (India): A global APIs supplier with established capabilities in antiviral APIs.

  • Vifor Pharma: Historically involved in the manufacturing and distribution of nucleoside analogs.

  These suppliers must meet stringent quality standards—GMP (Good Manufacturing Practice)—to ensure therapeutic efficacy and safety.

• Emtricitabine API Suppliers

  Emtricitabine APIs are procured from:

  • Sun Pharmaceutical Industries Ltd. (India): A major player with global API manufacturing.

  • Cansino Biologics (China): Known for nucleoside analogs and antiviral APIs.

  API sourcing tends to be diversified to mitigate geopolitical risks, supply disruptions, or shortages.

Formulation and Finished Goods Manufacturers

Gilead carries out the final formulation and packaging mainly via its state-of-the-art manufacturing facilities in the United States and Ireland, adhering to international regulatory standards. External CDMOs (Contract Development and Manufacturing Organizations) are also engaged to expand manufacturing capacity:

• Patheon (Part of Thermo Fisher Scientific)

• Novasep: Specializes in complex pharmaceutical formulations.

• Fujifilm Diosynth Biotechnologies: Provides fermentation and purification services.

The strategic use of external manufacturers ensures consistent product availability, especially amid global supply chain challenges.

Distribution and Logistics

Post-manufacture, Descovy is shipped globally through Gilead’s distribution networks, which include:

• Direct partnerships with major pharmaceutical wholesalers

• Regional distributors

• Government health agencies (e.g., CDC, national health ministries)

Distribution channels are tailored to meet local regulatory requirements, ensure cold chain integrity where necessary, and facilitate access in regions with varying infrastructure capabilities.

Regulatory and Quality Control Considerations

Suppliers for Descovy must comply with rigorous regulatory standards set by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japan Pharmaceuticals and Medical Devices Agency). Gilead performs comprehensive audits and quality assessments of suppliers to uphold safety and efficacy standards.

Risks and Challenges in the Supplier Ecosystem

Supply chain resilience remains paramount. Potential risks include:

• Raw material shortages: Limited availability of precursor chemicals or intermediates.

• Regulatory delays: Non-compliance or facility inspections causing production halts.

• Geopolitical issues: Trade tensions impacting international procurement.

• Generic manufacturer proliferation: Increasing competition may influence supplier dynamics and prices.

Providers continuously adapt sourcing strategies to mitigate these risks, including dual sourcing, inventory buffers, and supply chain diversification.

Emerging Trends and Future Directions

The complexity of HIV drug manufacturing necessitates ongoing innovation in supply chain management. Gilead and its suppliers explore:

• Synthetic improvements to enhance yield and reduce reliance on scarce raw materials.

• Supply chain digitization for real-time monitoring and quality assurance.

• Local manufacturing expansion to promote self-sufficiency in emerging markets.

These initiatives aim to secure the supply of Descovy amidst global challenges, ensuring uninterrupted access for patients worldwide.

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Key Takeaways

• Gilead Sciences predominantly manufactures the APIs and formulation of Descovy, sourcing raw materials globally.

• Major API suppliers include Chinese and Indian manufacturers specialized in nucleoside antivirals, providing diversification necessary for supply resilience.

• External CDMOs complement Gilead’s manufacturing, expanding capacity and meeting regional demand.

• Stringent regulatory compliance and continuous quality assessments underpin the supplier ecosystem.

• Supply chain risks encompass raw material shortages, geopolitical disruptions, and regulatory hurdles, which companies address through diversification and strategic planning.

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FAQs

1. Who are the main API suppliers for Descovy?
Major active pharmaceutical ingredient suppliers include Jiangsu Hengrui Medicine (China), Cipla (India), Sun Pharma (India), and Cansino Biologics (China), providing tenofovir alafenamide and emtricitabine.

2. Does Gilead rely solely on in-house manufacturing for Descovy?
No. Gilead combines in-house production with contracted pharmaceutical manufacturing organizations globally to meet demand and ensure supply chain robustness.

3. What risks threaten Descovy’s supply chain?
Risks include raw material shortages, geopolitical trade tensions, regulatory delays, and manufacturing disruptions, which companies mitigate through supplier diversification and strategic inventory management.

4. Are there regional variations in Descovy’s manufacturing?
While Gilead maintains core facilities in the U.S. and Ireland, regional manufacturing partnerships and distribution networks are established to facilitate global access, especially in low- and middle-income countries.

5. How does regulators’ oversight influence supplier quality?
Regulatory agencies enforce strict GMP standards. Gilead and its suppliers conduct rigorous audits, compliance checks, and quality controls to ensure that all ingredients and finished products meet international standards for safety and efficacy.

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References

[1] Gilead Sciences. (2022). Descovy Prescription Information.
[2] U.S. FDA. (2021). Drug Approvals and Manufacturing Inspections.
[3] GlobalData. (2022). Pharmaceutical Supply Chain Analysis.
[4] C&EN. (2021). API Manufacturing Trends.
[5] Gilead Sciences. (2022). Annual Report.