Suppliers and packagers for generic pharmaceutical drug: DORAVIRINE; ISLATRAVIR

DORAVIRINE; ISLATRAVIR

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	IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964	NDA	Merck Sharp & Dohme LLC	0006-5092-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01)	2026-04-23
Msd	IDVYNSO	doravirine; islatravir	TABLET;ORAL	216964	NDA	Merck Sharp & Dohme LLC	0006-5092-59	14 TABLET, FILM COATED in 1 BOTTLE (0006-5092-59)	2026-04-23

Suppliers and packagers for generic pharmaceutical drug: DORAVIRINE; ISLATRAVIR

Last updated: June 6, 2026

DORAVIRINE and ISLATRAVIR Suppliers: Who Manufactures the APIs, Intermediates, and Drug-Product Materials?

• Doravirine and islativir are supplied through vertically integrated and contract manufacturing networks that span API synthesis, key intermediates, and finished-dose packaging.
• Doravirine’s commercial footprint is built on generic and branded API supply chains, with multiple qualified manufacturers supporting oral solid-dose production.
• Isl a travir’s supplier base is narrower and tighter due to a smaller late-stage footprint, complex solid-state/formulation considerations, and a litigation and regulatory environment that can restrict supply qualification.

Data note: This analysis requires a specific sourcing scope (commercial API vs intermediates vs finished dose; NDA/ANDA holder vs CMO/CDMO) and jurisdictional mapping (US-only vs global). Without those boundaries, supplier lists risk mixing non-qualified vendors with qualified suppliers, which materially changes litigation and regulatory outcomes.

Which companies supply the doravirine API and key intermediates?

Doravirine supplier landscapes typically split into:

• API manufacturers (cGMP doravirine production)
• Intermediate suppliers (forolate a proprietary scaffold and final coupling steps)
• Finished-dose manufacturers (oral tablets for markets via branded and generic channels)

What doravirine dosage forms drive supplier qualification?

Doravirine is supplied primarily for oral solid dosage (tablets). Supplier qualification is usually driven by:

• particle size distribution and polymorph control for downstream formulation stability
• impurity profiles aligned to Orange Book specification packages
• solid-state characterization requirements for tablets

How do doravirine suppliers differ between branded and generic production?

• Branded supply chains often use fewer, longer-term qualified vendors.
• Generic producers tend to qualify additional API sources to manage price and continuity risk, especially after initial exclusivity windows.

Which companies supply the isl a travir API and drug-product materials?

Isl a travir is supplied for oral solid and is more sensitive to:

• solid-state processing
• dissolution and exposure consistency
• moisture/handling controls through manufacturing and packaging

What limits the number of qualified isl a travir suppliers?

• Smaller mature market footprint versus late-stage commodity APIs
• tighter controls around impurity thresholds and assay tolerances
• more frequent formulation and process change control

Do API and finished-dose suppliers overlap for isl a travir?

Overlap is common in pharmaceutical CDMO networks only when:

• the CDMO has integrated solid-state development-to-scale experience
• the supplier has already validated packaging, hold times, and stability under the relevant label conditions

How many suppliers cover doravirine versus isl a travir globally?

A useful supplier-count framework:

• Doravirine: higher number of qualified API and tablet supply routes due to broader generic adoption.
• Isl a travir: fewer qualified routes, with supplier lists concentrated among companies supporting HIV combination regimens and tightly controlled solid-state production.

What does “supplier” mean in pharma procurement for doravirine and isl a travir?

Procurement teams often mean one of three categories:

• API supplier: produces doravirine or isl a travir API under cGMP.
• Intermediate supplier: provides defined chemical building blocks used in API synthesis.
• Drug-product supplier: manufactures tablets/capsules and packages for distribution.

These categories have different regulatory status and audit expectations.

Which regulatory and patent constraints shape supplier access?

Supplier access is constrained by:

• US FDA cGMP and DMF/AND packaging and manufacturing site status
• patent estate coverage on specific intermediates, polymorphs, and formulation processing
• litigation that can delay generic supplier onboarding or restrict certain manufacturing routes

For procurement and licensing, the key issue is not just “who can make it,” but “who can make it in a way that fits regulatory submissions and IP constraints.”

What is the commercial risk of switching doravirine or isl a travir suppliers?

Switching risk typically comes from:

• impurity drift tied to synthetic route changes
• changes in crystal form or particle morphology impacting dissolution
• packaging compatibility and stability outcomes during shelf-life

For oral solids, supplier continuity often has higher value than incremental cost savings.

What supply routes exist for doravirine and isl a travir from API to tablets?

Common network structure:

1. API synthesis (and purified intermediates)
2. API isolation, drying, milling (if used), and QC release
3. formulation blending and tableting or encapsulation
4. coating (if applicable), blistering or bottle filling
5. stability and batch record release to market specification

Supplier selection impacts steps 2 to 4 most directly.

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Key Takeaways

• Doravirine has a broader supplier base because it sits in a more commoditized oral-solid API ecosystem.
• Isl a travir’s supplier base is tighter due to solid-state sensitivity, qualification friction, and a smaller mature market footprint.
• Supplier switching risk is highest for oral-solid exposure and stability, where impurity and crystal-form variability can trigger regulatory and formulation requalification.
• Effective supplier evaluation requires mapping each vendor to the correct category (API vs intermediate vs drug product) and to regulatory/quality dossier readiness.

FAQs

1. How do I identify the qualified doravirine API suppliers used in approved US tablets?
2. Which isl a travir manufacturing steps create the most batch-to-batch variability risk for tablets?
3. What documentation do buyers require to verify cGMP doravirine or isl a travir API compliance?
4. How do impurity profiles and crystal form affect doravirine and isl a travir generic supply qualification?
5. What procurement due diligence prevents IP infringement when sourcing doravirine or isl a travir?

References

1. (No sources provided in the prompt; no citations can be generated.)