Last Updated: July 17, 2026

Suppliers and packagers for KISQALI FEMARA CO-PACK (COPACKAGED)


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KISQALI FEMARA CO-PACK (COPACKAGED)

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 KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935 NDA Novartis Pharmaceuticals Corporation 0078-0909-61 1 KIT in 1 KIT (0078-0909-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0888-21) 2017-05-04
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935 NDA Novartis Pharmaceuticals Corporation 0078-0916-61 1 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14) 2017-05-04
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935 NDA Novartis Pharmaceuticals Corporation 0078-0923-61 1 KIT in 1 KIT (0078-0923-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0902-21) 2017-05-04
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for KISQALI FEMARA CO-PACK (COPACKAGED)

Last updated: June 11, 2026

Kisqali Femara co-pack (copackaged) suppliers: What manufacturing, packaging, and clinical-supply vendors support Novartis’s Kisqali + letrozole bundle

Executive summary: No public, reliably verifiable source identifies named “suppliers” or third-party manufacturers for the Kisqali Femara co-pack (copackaged) product’s drug substance, finished dosage forms, packaging, or co-pack assembly. Without confirmed manufacturer/packager identities tied to specific labels, NDCs, or contracts, a defensible supplier list cannot be produced.

Who supplies the drugs inside “Kisqali Femara co-pack (copackaged)”

Answer: The co-pack contains two branded products:

  • Kisqali (ribociclib)
  • Femara (letrozole)

Public supplier identification typically requires one of the following to be verifiable in a source: (1) an NDC-linked label identifying “manufactured for” and facility sites, (2) an FDA SPL entry showing listed manufacturing/packaging sites, or (3) a contract manufacturing/packaging announcement tied to the specific co-pack SKU. None is provided here.

Kisqali (ribociclib) supply chain naming

Answer: Named suppliers are not provided in the input.

Femara (letrozole) supply chain naming

Answer: Named suppliers are not provided in the input.

Which contract manufacturers pack and assemble the Kisqali + Femara co-pack

Answer: No named contract manufacturer or co-pack assembly vendor is provided.

What “co-pack” usually means in pharma

A co-pack typically involves:

  • producing finished dosage forms for each component separately
  • kitting and bundling them under one SKU or prescription product configuration
  • applying shared labeling, unit-of-use packaging, and distribution master packaging

Named vendors are normally discoverable only from labeler/manufacturer statements tied to a specific NDC/SKU.

How to identify the co-pack assembly site

A definitive supplier list requires label-level identification of:

  • “Manufactured for” / “Packed by” / “Distributed by”
  • packaging facility address
  • labeler of record and site codes in FDA SPL

Those identifiers are not provided in the input.

What is the Orange Book status of Kisqali Femara co-pack and does it list manufacturing sites

Answer: No Orange Book entry or manufacturing site mapping is provided for the specific co-pack.

Orange Book typically lists patent and exclusivity, not co-pack suppliers

Orange Book is patent/exclusivity focused. Co-pack supplier identification usually comes from:

  • FDA drug labeling and SPL manufacturing site disclosures
  • NDC labeler/manufacturer fields
  • inspection databases tied to site identifiers

No such details are provided here.

When does the Kisqali + Femara co-pack lose exclusivity and how does that affect suppliers

Answer: No co-pack exclusivity dates are provided.

What matters for supplier switching

Even after exclusivity or patent expiry, supplier transitions are driven by:

  • manufacturing capacity and regulatory qualification
  • packaging line validation and audit outcomes
  • supply continuity commitments and distribution agreements

No timeline data is included.

Which companies compete for co-packing services for oncology fixed combinations

Answer: No competitive supplier set is provided.

Common co-pack/kit service categories

  • blister and bottle packaging
  • unit-dose dispensing and kitting
  • multi-product packaging systems
  • 340B and specialty distribution operations

No vendor shortlist can be stated without source-backed evidence tied to this specific co-pack.

What regulatory filings reveal the co-pack suppliers

Answer: No FDA filing identifiers (NDC, labeler code, SPL submission, supplement number) are provided.

SPL fields that identify sites

Typical SPL datasets include:

  • applicant/labeler
  • manufacturing site addresses for each role (manufacturer, packager, labeler)
  • product type and packaging configuration

No such data is provided in the input.

Key Takeaways

  • The co-pack product “Kisqali Femara co-pack (copackaged)” includes ribociclib (Kisqali) and letrozole (Femara).
  • A named supplier list for the co-pack’s manufacturing, packaging, or kitting assembly cannot be produced from the provided information.
  • Supplier identification in practice requires NDC/SPL/label-level facility disclosures tied to the exact co-pack SKU.

FAQs

  1. How can I verify the packager for a co-pack SKU like Kisqali + Femara?
    Verify “manufactured for/packed by” and site addresses on the exact NDC/SKU label or its FDA SPL entry.

  2. Does FDA Orange Book list the co-pack manufacturer or kit assembly vendor?
    Orange Book mainly lists patents/exclusivity; manufacturing/packaging sites come from labeling/SPL disclosures.

  3. Are co-pack assembly suppliers the same as the finished drug manufacturers?
    Often they differ: finished drug manufacturers produce components; a separate vendor may kit and co-package.

  4. What documents identify the exact labeler of record for a co-pack?
    The labeler/manufacturer fields in NDC-related label data and FDA SPL records.

  5. Do supplier contracts change after exclusivity milestones?
    They can, driven by capacity, regulatory qualification, and supply continuity; changes still require site-level disclosures.

References (APA)

No sources were provided or cited because no verifiable supplier list for “Kisqali Femara co-pack (copackaged)” can be derived from the input.

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