Suppliers and packagers for generic pharmaceutical drug: Doravirine

Doravirine

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	PIFELTRO	doravirine	TABLET;ORAL	210806	NDA	Merck Sharp & Dohme LLC	0006-3069-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)	2018-07-20
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806	NDA	A-S Medication Solutions	50090-6268-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-6268-0)	2018-07-20

Suppliers and packagers for generic pharmaceutical drug: Doravirine

Last updated: May 26, 2026

Doravirine APIs and Key Suppliers: Who Manufactures the Active Ingredient and Where Does It Ship?

Doravirine supply chains cluster around a small number of API producers and a broader set of contract manufacturers (CMOs) that formulate and package doravirine tablets. The API market is typically supplied under cGMP dossiers for global regulatory submissions, with commercial availability concentrated in Asia and route-to-market via distributors that support bulk importation and finished-dose procurement.

Who are the doravirine API suppliers (active pharmaceutical ingredient manufacturers)?

The doravirine active pharmaceutical ingredient is manufactured by cGMP-capable API producers and is sold through direct commercial supply or distributor channels. In practice, companies that list doravirine as a sellable API generally fall into two buckets: (1) API manufacturers that produce doravirine through proprietary or licensed chemical synthesis, and (2) traders/distributors that aggregate API from underlying factories and supply packaged bulk.

API supply pattern

• Primary source geographies: China and India-led contract/API manufacturing ecosystems.
• Regulatory handling: API lots typically supplied with CoA, DMF/ASMF linkage where applicable, and full traceability for controlled quality systems.
• Commercial packaging: API usually supplied as bulk solid for downstream tablet manufacturing by third-party CMOs.

Named supplier identification No reliable, complete supplier roster with verifiable public evidence is available in the provided input, so a “who supplies doravirine” list cannot be produced without risking inaccuracies.

What contract manufacturing organizations make doravirine tablets (finished dosage manufacturers)?

Doravirine tablets are produced by pharmaceutical manufacturers operating as tablet CMOs or by the original drug manufacturer’s network. Finished-dose manufacturing involves:

• solid dosage formulation (excipients selection and blending),
• granulation and tableting,
• compression,
• coating,
• in-process controls (content uniformity, dissolution),
• packaging and labeling.

CMO selection drivers

• ability to support commercial scale under cGMP,
• experience with antiretroviral small molecules,
• capability to run stability programs and handle regulatory change control,
• quality system alignment for FDA and other agencies.

Named CMO identification No validated finished-dose manufacturer list can be produced from the provided input without introducing errors.

How do doravirine API sourcing and quality documentation work for FDA submissions?

When doravirine is used in FDA-submitted applications, quality documentation usually follows standard small-molecule regulatory practice:

• Drug Substance: API quality package aligned to DMF or an open dossier if the applicant holds the submission or references a listed file.
• Drug Product: manufacturing process controls, validation, specifications, and stability data.

Quality items that typically matter in sourcing

• polymorph/solid-state form control,
• residual solvents and genotoxic impurity profile,
• elemental impurities,
• particle size and flow properties for blending and compression,
• impurity clearance and stage-wise control strategy.

What this means for procurement Supply diligence for doravirine typically focuses on:

• ASMF/DMF reference status and letter of access if applicable,
• impurity control strategy and batch-to-batch consistency,
• audit history and deviation frequency,
• shipping lane documentation and cold-chain needs (usually not required for doravirine API, but humidity control for solids is common).

Which countries produce doravirine API and how does the supply chain differ by region?

Common regional split (industry norm for small-molecule APIs)

• China: large-scale chemical synthesis capacity and established API exporting infrastructure.
• India: strong generic API manufacturing base, with many export-ready units for cGMP dossiers.
• Europe/US: typically lower volume as API producers, with greater emphasis on oversight and distribution networks; some active ingredients may be sourced via global trading channels.

Region-specific risk points

• China/India: audit cadence, impurity profiling alignment, and documentation completeness.
• EU/US distributors: markups and lead times driven by compliance requirements and distribution margins.

What are the typical pricing and lead-time drivers for doravirine API?

Main pricing drivers

• campaign size and synthesis slot availability,
• number of competing API sources and normalized capacity utilization,
• regulatory status of reference filings,
• impurity control requirements that affect yield and cycle time,
• whether the API is supplied as a commodity or as dossier-supported supply for ANDA/505(b)(2) use.

Main lead-time drivers

• synthesis batch scheduling and intermediate availability,
• release testing turnaround time (impurities, residual solvents, water content),
• customs clearance and port lead times,
• whether stability and packaging requirements constrain shipping.

How does doravirine supplier selection affect ANDA and 505(b)(2) timelines?

Supplier selection is a timing issue because API qualification, analytical bridging, and change control can delay dossier finalization.

Where delays originate

• API changeovers (site transfer or process change),
• inconsistency in impurity profile versus the selected reference strategy,
• differences in solid-state form behavior under storage conditions.

Risk mitigation steps CMOs and applicants use

• lock supplier and manufacturing site early,
• require protocol-aligned exhibit batches for assay, impurities, dissolution performance,
• pre-define change control thresholds for impurity and specification drift.

What patent landscape impacts doravirine manufacturing and who can supply?

Doravirine is protected by patents and exclusivity that affect who can manufacture and market generic versions, which indirectly affects supply demand and pricing.

What matters for suppliers

• If the market is constrained by exclusivity, demand for generic API is lower and supply is oriented toward existing commercial volumes.
• If exclusivity barriers fall, generic and authorized generics raise API procurement velocity and expand supplier participation.

Named patent and exclusivity details A precise, date-by-date impact map cannot be compiled from the provided input.

Doravirine supply chain: API to tablet manufacturing workflow (procurement view)

Typical workflow

1. API supplier produces doravirine under cGMP with defined impurity controls.
2. API is shipped as bulk with CoA, spec sheet, and traceability documentation.
3. CMO receives API, performs incoming controls and full documentation review.
4. Tablet formulation run: blend, granulate (if applicable), compress, coat, pack.
5. Final release testing and stability program management for commercial distribution.

Contract terms that dominate execution

• Incoterms and shipping responsibilities,
• quality agreement and change notification windows,
• lot-release support and retest rights,
• rework and deviation responsibilities.

Key Takeaways

• Doravirine supply is generally handled through a limited number of cGMP API producers plus a wider network of CMOs and distributors that package and distribute for finished-dose manufacturing.
• Supplier selection is less about availability and more about dossier readiness: impurity profile control, solid-state form, and documentation linkage drive qualification time.
• A verified, named roster of doravirine suppliers cannot be provided from the provided input without risking false identifications.

FAQs

1. How can a buyer verify doravirine API regulatory dossier readiness (DMF/ASMF status)?
2. What solid-state form and impurity controls are most commonly scrutinized for doravirine API qualification?
3. What lead-time risks arise when switching doravirine API suppliers or manufacturing sites mid-project?
4. Do doravirine tablets require special packaging or stability controls that affect supplier selection?
5. How does exclusivity timing influence doravirine generic API demand and procurement strategy?

References

1. [No cited sources were provided in the user request. No external documents were supplied for citation.]