Suppliers and packagers for generic pharmaceutical drug: COBICISTAT; DARUNAVIR ETHANOLATE

COBICISTAT; DARUNAVIR ETHANOLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	A-S Medication Solutions	50090-1723-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)	2015-01-31
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	Janssen Products, LP	59676-575-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30)	2015-01-31
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	Janssen Products, LP	59676-578-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30)	2025-03-21

Suppliers for Cobicistat and Darunavir Ethanolate: API, Intermediates, and Finished-Dose Manufacturing

Last updated: May 23, 2026

Suppliers for cobicistat and darunavir ethanolate break into three lanes: (1) API manufacturers for each active, (2) intermediate suppliers used to build the API (and often also to produce back-up lots through tolling), and (3) finished-dose and packaging manufacturers for fixed-dose combinations and tablets. This article maps the supplier categories and the most common supply-chain structures used for these antiretrovirals, with emphasis on drug-substance sourcing for R&D, licensing, and generic development.

What API suppliers make cobicistat and where are contracts typically sourced from?

Cobicistat is typically supplied as pharmaceutical-grade API under either full-service manufacturing (solid-state/formulation support via DMF-linked batches) or tolling arrangements where the customer controls intellectual property, specifications, and sometimes the process route.

Which supplier archetypes dominate cobicistat supply?

1. DMF-linked API manufacturers

   • Provide API to multiple branded and generic customers under controlled specifications and release analytics.
   • Often hold an active Drug Master File with manufacturing site details that support rapid regulatory filing.

2. Toll manufacturers and “process owners”

   • The process and know-how may sit with a CDMO or with a specialty intermediate supplier.
   • Customer purchases API under their own DMF or supports ANDA/505(b)(2) cross-references.

3. Multi-product small molecule sites

   • Cobicistat is a complex, oxygenated small molecule. Supply is frequently clustered at sites that also run other HIV antivirals, boosting capacity utilization.

What does cobicistat supplier selection hinge on?

• Control strategy for impurities and residual solvents (cobicistat’s impurity profile is sensitive to route and crystallization conditions).
• Polymorph control and hydrate/solvate status (if applicable for the specific grade).
• Scale-up capability for high-purity lots required for clinical and commercial scale.

What API suppliers make darunavir ethanolate and how is the supply chain structured?

Darunavir ethanolate is produced under robust impurity-control and crystallization control, because the solid form and ethanol incorporation affect dissolution behavior and downstream formulation performance. Supplier qualification typically ties to reproducibility of the ethanolate form and compliance with regulatory expectations around polymorph/solvate consistency.

Which supplier archetypes dominate darunavir ethanolate supply?

1. High-potency HIV API manufacturers

   • Specialized small-molecule sites that support both branded and generic supply.
   • Provide ethanolate-consistent API and associated analytical packages.

2. Intermediate-driven supply chains

   • Darunavir manufacturing is often backed by suppliers of key intermediates that can also be routed through tolling.
   • Customers use intermediate capacity to reduce lead times and manage batch risk.

3. Clustered CDMO networks

   • Many suppliers run multiple protease inhibitors, enabling shared equipment qualification and analytical methods.

What does darunavir ethanolate supplier selection hinge on?

• Consistent formation of ethanolate during crystallization and stable conversion during storage.
• Impurity control aligned to regulatory filing thresholds.
• Ability to deliver batches for both development and commercial volumes without process drift.

Which finished-dose manufacturers supply cobicistat and darunavir fixed-dose products?

Cobicistat and darunavir are used in HIV treatment regimens, including co-formulated products that combine cobicistat as a pharmacokinetic enhancer with darunavir. Finished-dose supply typically includes tablet manufacturing and packaging by separate entities (tablet press and blister/bottle packaging can be decoupled).

Finished-dose supplier patterns for these antivirals

• Primary contract manufacturer (tablet core and coating)

  • Handles granulation, blending, tableting, coating, and in-process controls.

• Secondary packaging and labeling subcontractors

  • Provides finished packaged goods (blisters, bottles, cartons) with track-and-trace-ready workflows.

• Multi-site supply for continuity

  • Branded and generic programs often qualify at least two sites to reduce supply interruption risk.

What suppliers provide cobicistat and darunavir ethanolate intermediates?

Intermediate sourcing is a major lever for lead-time and cost control. For both actives, suppliers often provide one of: (1) key building blocks used in early-stage synthesis, (2) late-stage intermediates that determine final impurity profile, or (3) crystallization-critical precursors that drive solid-form outcomes.

Intermediate supplier categories

• Key intermediate manufacturers

  • Deliver advanced intermediates with defined specs to enable final API synthesis without changing core route parameters.

• Route-specific intermediate tolling

  • Process owner dictates route; toller provides manufacturing capacity.

• Analytical support-linked intermediate supply

  • Suppliers provide not only material but also impurity characterization data packages used during scale-up.

How are supplier contracts structured for cobicistat and darunavir ethanolate: DMF, QMS, and tech transfer?

Supplier onboarding for high-complexity HIV antivirals is usually governed by a technical package that supports quality agreement execution and regulatory confidence.

Typical contract and compliance mechanics

• DMF cross-reference and site eligibility

  • Customers require that the supplier’s DMF (or alternative regulatory file) covers the manufacturing site and process stage.

• Quality management system alignment

  • Audit packages include deviations, CAPA maturity, OOS handling, and change control.

• Tech transfer triggers

  • Process changes require bridge data or full revalidation depending on criticality (especially for solvate/solid-form).

What patent and regulatory constraints affect supplier switching for cobicistat or darunavir?

Supplier switching is constrained by IP and regulatory pathway dependencies. For branded products and certain combination presentations, formulation and manufacturing method patents can indirectly affect how and when a new supplier can introduce its process without triggering bridging requirements.

Regulatory switching risk points

• Solid form controls for darunavir ethanolate

  • Any meaningful change in crystallization conditions may require stability bridging.

• Impurity profile drift for both actives

  • Different routes can shift impurity levels, requiring analytical method alignment and regulatory reporting.

IP switching risk points

• Process patents and intermediate-use claims
  • Even if API structure is the same, route-to-route IP can matter in commercial manufacturing and tech transfer.

What generic entry risks exist for cobicistat and darunavir ethanolate supply?

Supply-chain risk is often operational rather than chemical, but it can still block generic entry if the supplier cannot demonstrate equivalence to the reference-listed quality attributes.

Common generic entry blockers

• Inability to reproducibly form the correct solid form (especially darunavir ethanolate).
• Impurity profile mismatches that exceed spec without compensatory process controls.
• Failure to transfer the analytical methods and release criteria under a validated quality system.

How do cobicistat and darunavir supplier ecosystems differ in consolidation and capacity?

Cobicistat’s supply often concentrates at fewer specialized sites due to impurity-control and crystallization complexity. Darunavir ethanolate can show wider supplier availability over time because the molecule has broader historical commercial demand, but the “ethanolate-consistent” constraint narrows qualification to fewer eligible facilities.

Practical impact

• Cobicistat: higher likelihood of capacity constraints at specific qualified sites, especially around tech transfer and stability commitments.
• Darunavir ethanolate: more established supply base, but eligibility still depends on solid-form control and impurity acceptance.

How should buyers evaluate supplier strength for cobicistat and darunavir ethanolate?

Supplier strength for these actives can be assessed through measurable readiness indicators rather than vendor claims.

Supplier evaluation checklist (high signal)

• DMF coverage and amendment history
• Batch failure rate and deviation trends over the last 12 to 24 months
• Solid-form characterization capability (for darunavir ethanolate)
• Analytical method robustness and transfer time-to-qualification
• Change control track record and responsiveness to regulatory queries

Key Takeaways

• Supplier ecosystems for cobicistat and darunavir ethanolate typically segment into DMF-linked API manufacturers, intermediate suppliers, and separate finished-dose/packaging subcontractors.
• Darunavir ethanolate supply is constrained more tightly by solid-form reproducibility than by bulk chemistry alone.
• Cobicistat supply is constrained by impurity control and crystallization reproducibility, which increases qualification friction during tech transfer.
• Generic and biosimilar-adjacent entry for HIV antivirals is frequently blocked by equivalence demonstration issues tied to solid form (darunavir) and impurity profile (cobicistat and darunavir).

FAQs

Who supplies cobicistat API for fixed-dose darunavir combinations?

API supply for cobicistat is typically provided by DMF-linked small-molecule manufacturers that also support HIV antiviral portfolios and can deliver consistent impurity profiles aligned to regulatory specs.

Can a darunavir ethanolate supplier change the solid-form without regulatory bridging?

Any meaningful change in crystallization/solvate outcome can trigger bridging obligations, especially for stability and bioequivalence-related quality attributes.

What is more critical for supplier qualification: impurity profile or solid form for darunavir ethanolate?

Solid form and impurity profile are both critical, but darunavir ethanolate qualification is especially sensitive to solvate consistency and its impact on dissolution and stability.

How do DMF listings affect the ability to switch cobicistat or darunavir suppliers?

DMF coverage by manufacturing site and process stage determines regulatory ease of substitution and the speed at which customers can file cross-references or support their own regulatory package.

What supply-chain risks most often delay generic launches for these antivirals?

Delays commonly come from inability to reproducibly meet solid-form and impurity specs, slow analytical method transfer, and insufficient stability data to support release and shelf-life claims.

References

1. FDA. Drug Master Files (DMF) overview. U.S. Food and Drug Administration. (FDA website).
2. FDA. ANDA quality considerations and solid form / bioequivalence-related guidance resources. U.S. Food and Drug Administration. (FDA website).