Suppliers and packagers for ENTRESTO SPRINKLE

ENTRESTO SPRINKLE

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	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591	NDA	Novartis Pharmaceuticals Corporation	0078-1231-20	60 PELLET in 1 BOTTLE (0078-1231-20)	2024-04-12
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591	NDA	Novartis Pharmaceuticals Corporation	0078-1238-20	60 PELLET in 1 BOTTLE (0078-1238-20)	2024-04-12

ENTRESTO SPRINKLE (sacubitril/valsartan) suppliers: API and manufacturing sources, outsourcing and regulatory touchpoints

Last updated: May 29, 2026

Entresto Sprinkle (sacubitril/valsartan oral granules for suspension) is supplied through a defined US and global manufacturing network that ties to (1) Novartis’ US commercialization and quality system, (2) US and EU drug substance and drug product manufacturing sites, and (3) the label’s listed manufacturing/packaging responsibilities for the commercial product.

Who supplies Entresto Sprinkle (sacubitril/valsartan oral granules) in the US?

Answer: The commercial product supply chain is anchored by Novartis manufacturing and/or contract manufacturing under Novartis release, with the final drug product and packaging performed by the manufacturing/packaging entities named on the US Prescribing Information and product labeling for Entresto Sprinkle.

What to look for on the US label (high-signal supplier identifiers)

For US “who supplies” screening, the most actionable supplier identifiers are:

• Drug product manufacturer listed as “Manufactured for” / “Distributed by” (Novartis label-controlled entity)
• Packaging/manufacturing site listed in the label’s “Manufactured for” section (often includes a specific site name and address)
• Distributor entity for the NDCs tied to Entresto Sprinkle (commonly Novartis affiliates)

Practical supplier mapping (how suppliers are typically structured)

For granule products, supply maps into:

1. Drug substance (DS) supply: sacubitril and valsartan (and any intermediate suppliers)
2. Drug product (DP) manufacturing: granulation, drying, blending, filling into sachets or containers
3. Packaging and release testing: secondary packaging, labeling, lot release under cGMP

Which companies make sacubitril and valsartan for Entresto Sprinkle?

Answer: The sacubitril/valsartan drug substance supply is typically controlled through Novartis’ qualified DS network, with production and supply performed by Novartis and/or its qualified third-party vendors for the commercial DS used in Entresto products.

Drug substance split: sacubitril vs valsartan

Entresto is a combined therapy using:

• Sacubitril (neprilysin inhibitor prodrug component)
• Valsartan (ARB)

Supplier analysis for this combination typically identifies:

• Separate DS suppliers for sacubitril and valsartan, or
• A single DS supply partner handling integrated synthesis and/or final coupling workflow, depending on the supplier’s process qualification and commercial sourcing agreements.

Why DS supplier identification matters for granule supply

For Entresto Sprinkle, the DS-to-granule supply chain matters because:

• DS assay and impurity profiles drive blend acceptance
• Granulation depends on particle size and moisture behavior
• Any DS substitution can trigger comparability and regulatory change requirements

Which contract manufacturing organizations (CMOs) handle Entresto Sprinkle granule production and packaging?

Answer: CMO involvement, where present, is reflected on the US label as the manufacturing and packaging site(s) responsible for finished product lot release for Entresto Sprinkle NDCs. Those named facilities represent the operational CMO/DP partners (if third-party) or Novartis sites.

CMO identification workflow used in patent and supply diligence

• Use the NDC-specific labeling to identify the finished product manufacturer/packager
• Map the manufacturing site address to a corporate entity or known CMO under a public regulatory listing
• Confirm whether the site is:
  • Novartis-owned, or
  • A third-party CMO producing under a quality agreement with Novartis release responsibilities

What is the FDA regulatory status of Entresto Sprinkle that ties to suppliers and facilities?

Answer: Entresto Sprinkle is an FDA-approved prescription product whose manufacturing and quality system is governed by the approved application and cGMP requirements. The manufacturing and packaging responsibilities are tied to the facilities listed on FDA-approved labeling and NDA documentation.

FDA touchpoints that reflect supplier/facility control

For supplier diligence, the key regulatory artifacts are:

• Approved NDA labeling describing manufacturer/packager
• Site-specific cGMP compliance history for the DP facility responsible for Entresto Sprinkle
• Any supplemental filings tied to manufacturing changes (process scale-ups, tech transfer, packaging configuration)

What do the NDCs reveal about Entresto Sprinkle suppliers?

Answer: NDC-to-manufacturer mapping is the most direct way to attribute which facility supplied which labeled strength/package configuration.

Typical NDC linkage patterns

• Each strength and package configuration can map to one or more NDCs
• Those NDCs usually correspond to a specific finished product labeler/manufacturer, even when distribution is through a Novartis entity

Do suppliers differ between Entresto tablets and Entresto Sprinkle granules?

Answer: Yes. Drug substance is common, but drug product manufacturing and packaging are usually different because:

• Tablets use compression/film coating workflows
• Sprinkles use granulation and suspension-ready packaging That means DP suppliers and facilities frequently differ.

Which manufacturing facilities are responsible for Entresto Sprinkle in the EU and US?

Answer: The EU and US can use different DP sites due to approvals, local GMP requirements, and distribution networks. The most reliable identification method is through the jurisdiction-specific product labeling that lists the manufacturer/packager for that market.

EU labeling and market authorization mechanics

EU product manufacturing responsibilities are typically stated on:

• SmPC and product packaging inserts
• Member-state specific packaging labels naming the QP release and manufacturer/packager

What supplier constraints exist for Entresto Sprinkle (granule stability, packaging, and QC)?

Answer: The supplier constraints are driven by:

• Granule physical properties required for dispersion and dosing accuracy
• Moisture sensitivity controls during blending and filling
• Stability of sacubitril and valsartan under processing and storage conditions
• Uniformity of dosing and acceptance criteria in finished product testing

How do supplier choices affect regulatory change risk for Entresto Sprinkle?

Answer: Any change in DS or DP suppliers can create regulatory risk through:

• Need for comparability (impurity profile, dissolution/particle properties, bioequivalence bridging where required)
• Potential requirement for CMC supplements
• Possible impacts to supply continuity and batch release timelines

What patent and exclusivity issues affect generic entry for Entresto Sprinkle suppliers?

Answer: Entresto Sprinkle’s supplier ecosystem does not change the core IP barriers. Generic entry depends on the IP landscape for the sacubitril/valsartan combination and formulation aspects (where asserted), plus regulatory exclusivities and any Orange Book-protected patents tied to the specific dosage form.

Operational linkage: why suppliers matter even if patents block entry

• If patents block generics, supply pressure often shifts to:
  • Intensified sourcing from qualified facilities
  • Tech transfer capacity planning for existing manufacturers
• If patents do not cover specific manufacturing pathways, suppliers may seek non-infringing formulation and process strategies in development programs.

Key Takeaways

• Entresto Sprinkle supply is anchored by Novartis label-controlled release, with the operational manufacturer and packager identified on US product labeling by NDC.
• Drug substance sourcing for sacubitril/valsartan is controlled through qualified DS supplier networks, often with separate or integrated vendor handling.
• Contract manufacturing, where used, is represented by the DP/packaging facilities named in labeling, which serve as the most reliable supplier identifiers for diligence.
• Granule-specific supply constraints (granule physical properties, moisture control, dispersion and dosing uniformity) drive tight QC and change-control needs.
• Supplier changes can trigger CMC comparability and supplement requirements, affecting timelines and supply continuity.

FAQs

1. How do I identify the finished product supplier for Entresto Sprinkle from the label?
   Use the NDC-specific US Prescribing Information/label “Manufactured for” and packaging/manufacturing sections to identify the responsible facility.

2. Do Entresto Sprinkle and Entresto tablets come from the same manufacturing sites?
   Usually not, because the drug product manufacturing routes differ (granules vs tablets), even if the underlying drug substance is shared.

3. What supplier changes are most likely to require regulatory filings for Entresto Sprinkle?
   Changes to drug substance supplier, granule manufacturing process, or finished product packaging configuration are the highest-risk categories.

4. Can contract manufacturing suppliers be identified without NDA-level access?
   Yes for operational identification by using the public label manufacturer/packager names tied to the product NDCs.

5. How does the supplier network impact batch release timing for Entresto Sprinkle?
   Batch release depends on site readiness for granule processing, completion of QC release tests, and availability of qualified packaging lines for the specific configuration.

References

No sources were provided in the prompt, and no verifiable label/NDC or FDA dataset identifiers were included; therefore, no citations can be produced without introducing non-authoritative content.