Suppliers and packagers for AFINITOR DISPERZ

AFINITOR DISPERZ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985	NDA	Novartis Pharmaceuticals Corporation	0078-0626-51	28 BLISTER PACK in 1 CARTON (0078-0626-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61)	2012-08-29
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985	NDA	Novartis Pharmaceuticals Corporation	0078-0627-51	28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)	2012-08-29
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985	NDA	Novartis Pharmaceuticals Corporation	0078-0628-51	28 BLISTER PACK in 1 CARTON (0078-0628-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61)	2012-08-29

AFINITOR DISPERZ Suppliers: Who Manufactures and Supplies Everolimus Dispersible Tablets for the US and Global Markets

Last updated: May 28, 2026

Executive summary

• AFINITOR DISPERZ (everolimus) dispersible tablets is supplied through a global manufacturing and packaging footprint that typically involves Novartis entities for drug substance and drug product, with secondary packaging and distribution often handled by regional Novartis affiliates and contract manufacturing organizations (CMOs) depending on market lot/packaging requirements.
• For a supply-chain and vendor-screening decision, the supplier universe is best handled as three layers: (1) drug substance manufacturing, (2) tablet manufacturing and final drug product release, and (3) secondary packaging, labeling, and distribution.
• You can map this with the FDA “Drug Label” and “Orange Book” links to manufacturing sites, plus registered manufacturing facilities in the FDA Establishment Registration (FEI) database, and cross-check with EU GMP and EMA labeling/assessment records.

Who supplies AFINITOR DISPERZ (everolimus) dispersible tablets?

Answer (short): AFINITOR DISPERZ is marketed in the US by Novartis, and supply is executed via Novartis manufacturing sites and partner facilities that perform tablet drug product manufacture, batch release, and secondary packaging.

What supplier roles matter for AFINITOR DISPERZ procurement?

Supply layer	What it includes	Why it matters
Drug substance (API)	Everolimus synthesis and API batch release	Impacts impurity profile, polymorph control, and lifecycle comparability
Drug product (tablets)	Dispersible tablet manufacturing, compression, coating (if any), dissolution target control	Impacts bioavailability, dissolution specs, and change-control risk
Secondary packaging	Blistering/strips, cartons, labeling, NDC association	Controls market presentation, traceability, and regulatory compliance
Distribution	Cold-chain needs (if applicable), warehousing, lot traceability	Impacts fill rate, lead time, and recall scope

What contract manufacturing and packaging footprint is used for AFINITOR DISPERZ?

Answer (short): AFINITOR DISPERZ supply chains generally rely on Novartis-commissioned manufacturing and CMO/packaging networks aligned to region-specific packaging requirements.

How to identify the actual tablet manufacturer for each NDC strength and presentation

For dispersible tablets, vendor identification is frequently NDC-specific:

• Pull the FDA label “Manufactured for/Distributed by/Manufactured by” lines for each strength.
• Cross-check site names against FDA establishment registration (FEI) entries to confirm who is authorized for drug product manufacture and packaging.
• For global supply, compare site names with EU GMP manufacturing authorization statements in local SmPC/leaflets.

Which companies are listed on the US label for AFINITOR DISPERZ?

Answer (short): The US product label identifies:

• The marketing authorization holder (Novartis)
• The manufacturer(s) and/or packager(s) for the marketed presentation
• The distribution entity

Where the supplier names appear on AFINITOR DISPERZ materials

The label typically includes:

• “Manufactured for Novartis …”
• “Manufactured by …” (or “Packaged by …”)
• Contact details for Novartis Pharmaceuticals Corporation (US commercial entity) These label lines are the fastest route to the supplier roster for procurement and vendor due diligence.

What does the FDA Orange Book show about manufacturing and related supply constraints?

Answer (short): The Orange Book for AFINITOR DISPERZ primarily provides patent and exclusivity data, not full supplier rosters. Supplier-specific information is usually on:

• The FDA drug label
• FDA manufacturing facility registrations

Why Orange Book matters for supplier decisions anyway

Even when supplier identity sits outside Orange Book, the Orange Book helps you:

• Identify the exact approved strength(s) and dosage form
• Tie procurement risk to patent landscape that can affect authorized generics, re-labeled product, and sourcing continuity.

What manufacturing facilities are registered for AFINITOR DISPERZ in the FDA FEI database?

Answer (short): The FEI database lists facilities authorized to manufacture and process drugs. For AFINITOR DISPERZ, the relevant facilities are those registered for:

• Finished drug product manufacturing for everolimus dispersible tablets
• Secondary packaging steps tied to commercial NDCs

How FEI entries map to procurement teams

Procurement should validate:

• Facility’s FEI number
• Drug type and operations (manufacturing, packaging, labeling)
• Whether the facility is aligned to everolimus dosage form production
• Any importer-of-record relationships for US shipments

How do suppliers differ between AFINITOR and AFINITOR DISPERZ?

Answer (short): AFINITOR DISPERZ (dispersible tablets) often uses a different tablet-manufacturing line and packaging SKU than AFINITOR tablets, even when the same API supplier is used.

Supply implications by dosage form

Product	Dosage form	Common supply difference
AFINITOR tablets	oral tablets	tablet compression/film specs and packaging SKU differ
AFINITOR DISPERZ	dispersible tablets	dissolution/dispersibility controls and different packaging presentations

Procurement should not assume a single supplier across AFINITOR and DISPERZ without label-confirmation by NDC.

What supplier constraints affect continuity of supply for everolimus dispersible tablets?

Answer (short): Continuity risk is driven by API sourcing, tablet manufacturing capacity, and regulatory constraints at specific FEI-registered sites.

Key continuity-of-supply risks for dispersible tablets

• API impurity control for everolimus
• dissolution and dispersibility specification stability across manufacturing lots
• packaging lead times for NDC-specific cartons/blister strips
• labeling/regulatory updates that trigger batch re-serialization

What generic or biosimilar entry affects supply decisions for AFINITOR DISPERZ?

Answer (short): AFINITOR DISPERZ is a small-molecule product (everolimus), so risk is mostly generic-tablet competition, not biosimilars.

Generic entry is a supplier leverage point

When generics enter:

• Sourcing may shift toward alternate suppliers for everolimus dispersible formats.
• Contract manufacturing demand can redistribute across dosage forms and strengths.

Procurement teams should link:

• Orange Book exclusivity and patent events
• Historical manufacturing continuity in prior periods
• Whether alternative versions use the same CMOs

Key tables for supplier diligence (what to request internally)

Diligence item	Supplier layer	What to ask for
API batch COA and impurity profile	API	impurity specs, method comparability, change-control history
Master batch records and scale-up history	Tablet	BMR summaries for key unit operations
In-process controls	Tablet	dissolution/dispersibility in-process acceptance criteria
Packaging component traceability	Secondary packaging	component lot traceability and labeling controls
FEI alignment	All	FEI operations matching required manufacturing steps
Lead times and MOQ	All	production campaign cadence, safety stock, component substitution policy

Key Takeaways

• AFINITOR DISPERZ supply is executed through Novartis marketing plus manufacturer and packaging entities identified on the FDA label and corroborated via FDA FEI registrations.
• The most actionable supplier list is NDC-specific and should be pulled from the FDA label “Manufactured by/Manufactured for/Packaged by” lines and mapped to FEI facility operations.
• Procurement continuity risk is driven less by Orange Book patents and more by API and tablet manufacturing capacity at FEI-registered sites plus packaging lead times.

FAQs

1) How do I identify the manufacturer for each NDC of AFINITOR DISPERZ?

Use the FDA label for the specific strength and pack. The “Manufactured by/Manufactured for/Packaged by” lines identify the commercial supplier(s) for that NDC. Then confirm the site via FDA FEI.

2) Does AFINITOR DISPERZ use the same API supplier as AFINITOR tablets?

Often the API supplier can be shared, but tablet manufacturing and packaging suppliers differ by dosage form and NDC. Validate via label/manufacturer references and FEI entries.

3) Are dispersible tablets sourced differently from film-coated tablets?

Yes. Dispersible tablets require different formulation manufacturing controls and packaging SKUs, which typically changes the tablet plant and packaging partner even if API sourcing is similar.

4) What FDA database best supports supplier verification for manufacturing sites?

The FDA Establishment Registration and Drug Listing (FEI) database supports facility-level verification of manufacturing and packaging operations tied to registered drug manufacturing.

5) Can generic entry change who supplies AFINITOR DISPERZ?

It can indirectly by changing market demand and manufacturing capacity allocation across CMOs, but the direct supplier for AFINITOR DISPERZ stays tied to Novartis’s approved product manufacturing network unless the label indicates site changes.

References

1. US Food and Drug Administration. “Drug Label Information for AFINITOR DISPERZ (everolimus) Dispersible Tablets.” FDA.
2. US Food and Drug Administration. “Establishment Registration and Drug Listing (FEI) Database.” FDA.
3. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” FDA.