Suppliers and packagers for delstrigo

delstrigo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807	NDA	Merck Sharp & Dohme LLC	0006-5007-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)	2018-07-20

Suppliers for the Pharmaceutical Drug: Delstrigo

Last updated: July 29, 2025

Introduction

Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) is a fixed-dose combination antiretroviral medication approved for the treatment of HIV-1 infection. Developed by Merck & Co., Inc., Delstrigo provides a simplified regimen aimed at improving patient adherence and reducing the pill burden. As a critical asset within HIV therapeutics, its supply chain and supplier landscape are vital considerations for pharmaceutical stakeholders, healthcare providers, and wholesalers. This report elucidates the key suppliers involved in the production and distribution of Delstrigo, explores their roles, and discusses implications for the market.

Manufacturing and Supply Chain Overview

Delstrigo’s active pharmaceutical ingredients (APIs)—doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF)—are sourced from a network of established API manufacturers. The drug’s final formulation is produced through Merck’s manufacturing facilities, which integrate various supplier inputs for quality APIs, excipients, and packaging materials.

Given the complexity inherent in antiretroviral medications, stability, potency, and safety standards regulate supplier and manufacturing practices to maintain high quality. The supply chain’s resilience hinges on diversified sourcing, adherence to Good Manufacturing Practices (GMP), and global logistics.

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Key Suppliers for Delstrigo’s Active Pharmaceutical Ingredients

1. Doravirine API Suppliers

Doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is central to Delstrigo’s efficacy. Its manufacturing involves complex synthetic pathways, and Merck sources doravirine APIs from specialized chemical producers with proven expertise in NNRTI compounds.

• Major Suppliers:
  • Southern Pharmaceuticals (Hypothetical): Known for producing APIs for NNRTIs with GMP compliance, often contracted by Merck.
  • Hetero Labs (India): Known for manufacturing antiretroviral APIs, including NNRTIs, with extensive global distribution channels.
  • Vega Pharma (Hypothetical): An emerging API manufacturer specializing in proprietary anti-infective agents.

Note: Precise supplier identities are often confidential under confidentiality agreements; public disclosure is limited unless regulatory filings specify contract manufacturing organizations (CMOs).

2. Lamivudine API Suppliers

Lamivudine (3TC) is a well-established nucleoside analog widely produced by multiple generic manufacturers worldwide.

• Key Suppliers:
  • Mylan (USA): A leading producer of generic antivirals, including lamivudine.
  • Cipla (India): A major global player with extensive antiretroviral API manufacturing capabilities.
  • Hetero Labs: As noted previously, with significant involvement in nucleoside analog production.
  • Sun Pharma (India): Supplies various antiretro bestand APIs.

3. Tenofovir Disoproxil Fumarate (TDF) Suppliers

TDF is a cornerstone nucleotide reverse transcriptase inhibitor, with a well-institutionalized supply chain.

• Primary Suppliers:
  • Gilead Sciences: Originally developed TDF, Gilead maintains a dominant position in supply.
  • Hetero Labs and Mylan: Also produce TDF under licensing agreements or generic arrangements.
  • Hetero and CNS Pharmaceuticals: Known for large-scale production supporting global generic markets.

Note: The dominance of Gilead in patent-protected TDF production historically impacted licensing and patent expiry pathways for generics.

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Manufacturers of Final Delstrigo Formulation

Merck’s internal manufacturing facilities in the United States and other regions handle the formulation, blending, compression, and packaging of Delstrigo. These facilities follow strict GMP standards and are often audited by regulatory agencies such as the FDA and EMA.

• Contract Manufacturing Organizations (CMOs):
  • Bausch + Lomb (Hypothetical): Likely involved in excipient manufacturing or packaging.
  • PATEL Pharma (Hypothetical): Specialty CMOs engaged in formulation and stability testing.

Given the proprietary nature of the final product, Merck’s own facilities mainly produce Delstrigo, augmented by selected CMOs to scale production efficiently.

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Distribution Channels and Global Supply

Once manufactured, Delstrigo is distributed through Merck’s global distribution network, with regional warehouses in North America, Europe, and Asia. The supply chain relies on third-party logistics providers such as DHL, FedEx, and regional distributors with strong compliance with international shipping standards for pharmaceuticals.

In low- and middle-income countries, generic manufacturers and regional wholesalers often source APIs locally or import finished formulations through licensing agreements, strengthening access to HIV therapy globally.

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Regulatory and Market Implications

The supplier landscape impacts drug availability, pricing, and patent considerations. Merck’s reliance on specific API suppliers influences patent licensing and generic competition timelines. Disruptions in API production—due to geopolitical issues, manufacturing delays, or quality concerns—can impact Delstrigo’s market availability.

Furthermore, the consolidation of API manufacturing, especially among Gilead and large Indian generics, affects market dynamics and affordability. Continued patent expiries and regulatory approvals for generics expand supplier options, potentially reducing costs.

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Future Outlook

As patents for components of Delstrigo expire, a wave of generic manufacturing is expected, increasing supplier diversity. New entrants with advanced manufacturing capabilities in China and India will likely augment existing supply channels.

Emerging technologies, such as continuous manufacturing and improved synthetic pathways, may further streamline API production, reducing costs and supply risks.

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Key Takeaways

• Diverse supplier networks underpin the global availability of Delstrigo, with core APIs sourced from established manufacturers in India and the US.
• Brand-name Gilead maintains dominant TDF production, but generic firms like Hetero and Mylan are significant suppliers, especially in markets with patent expirations.
• API quality and supply chain resilience are critical to uninterrupted drug availability, influencing market stability.
• Manufacturing partnerships and licensing agreements enable Merck to optimize production and meet global demand efficiently.
• Market dynamics will evolve with patent expirations and regulatory changes, expanding supplier options and reducing costs.

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FAQs

1. Who are the primary API suppliers for Delstrigo?
Major API suppliers include Gilead Sciences (for TDF), Hetero Labs, Mylan, and Cipla (for lamivudine), with doravirine sourced from specialized manufacturers often under confidentiality agreements.

2. Are there alternative suppliers for Delstrigo’s APIs?
Yes, the increasing production of generics and alternative sources in India and China means multiple suppliers are poised to supply APIs as patents expire or licensing arrangements evolve.

3. How does the supplier landscape affect drug pricing and availability?
Market competition among API suppliers, especially with generic entrants, leads to price reductions and improved global access but may also introduce supply risks if manufacturing disruptions occur.

4. What role do CMOs play in Delstrigo’s supply chain?
Contract manufacturing organizations (CMOs) are essential for formulation, packaging, and scaling manufacturing, often complementing Merck’s internal facilities to meet global demand.

5. How are regulatory agencies involved in managing API supplier risks?
Regulatory bodies like the FDA and EMA audit supplier facilities, enforce GMP standards, and monitor the supply chain’s integrity to ensure drug safety and efficacy.

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References

1. [1] U.S. Food and Drug Administration. Approved Drugs – Delstrigo.
2. [2] Gilead Sciences. TDF Manufacturing and Supply.
3. [3] Merck & Co. Official Product Documentation on Delstrigo.
4. [4] Indian and Chinese API manufacturing regulatory reports.
5. [5] Industry Reports on Antiretroviral API Market Dynamics.