Suppliers and packagers for ZYKADIA

ZYKADIA

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	ZYKADIA	ceritinib	TABLET;ORAL	211225	NDA	Novartis Pharmaceuticals Corporation	0078-0694-48	21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)	2019-03-18
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225	NDA	Novartis Pharmaceuticals Corporation	0078-0694-84	84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)	2019-03-18

ZYKADIA (ceritinib) suppliers: contract manufacturers, API makers, and key upstream sources

Last updated: May 29, 2026

Executive summary: ZYKADIA (ceritinib) is manufactured through a network of contract manufacturers and upstream material suppliers. The specific supplier set depends on dosage form (currently tablets), strength, and market-specific packaging. The most operationally relevant supplier footprint for ZYKADIA is: (1) ceritinib API procurement from specialized small-molecule manufacturers; (2) formulation and tablet finishing by CDMOs; and (3) packaging and secondary-label distribution by regional packagers. Only the FDA’s drug product listing and Orange Book patent/product listings can reliably anchor the “who supplies what” map across strengths and geographies.

Who supplies ZYKADIA (ceritinib) API and drug product manufacturing?

Direct answer: The supplier names for ZYKADIA’s ceritinib API and finished tablets are not determinable from the prompt alone. A complete, accurate supplier map requires the FDA label/manufacturer section and the Orange Book drug product “Applicant/Manufacturer” field(s) by strength and NDC.

What supplier roles exist in ZYKADIA’s supply chain?

1. API manufacturers (ceritinib): manufacture and release ceritinib active ingredient used by the drug product site(s).
2. Drug product CDMOs: formulate, blend, compress/coat, and perform in-process controls and final tablet release.
3. Packagers/distributors: bottle/blister pack and perform secondary labeling for the labeled strengths and markets.

How do strengths and NDCs change the supplier list?

• ZYKADIA has multiple strengths and may have different manufacturing sites per strength due to capacity allocation and regulatory site qualification.
• Supplier identity can vary by:
  • site-specific FDA approval
  • labeler/holder versus manufacturer
  • market and packaging configuration (bottles vs cartons, blister formats if used)

Which contract manufacturing organizations (CMOs) make ZYKADIA tablets?

Direct answer: The CDMO/CMP identity for ZYKADIA’s tablet manufacturing is not determinable from the prompt alone because it must be pulled from:

• the US prescribing information “Manufactured for” and “Manufactured by” sections, and
• the Orange Book drug product listing per strength/NDC.

What CDMO disclosures exist for small-molecule oncology drugs?

For oncology small molecules, labels commonly separate:

• drug product manufacturer (site that makes tablets)
• packager (site that packages)
• application holder (brand rights entity)

Those fields can point to multiple entities across the supply chain even when the brand labeler is constant.

What companies supply ceritinib bulk drug substance (API)?

Direct answer: A definitive API supplier list cannot be produced from the prompt alone. Ceritinib API sourcing depends on the approved API manufacturing site(s) used in current GMP registrations and label “manufactured by” statements.

Where API suppliers appear in regulatory filings

• Labeling and FDA drug listing documents generally tie API and drug product sites to:
  • FDA DMF reference (for DMF-linked API sources)
  • Orange Book entries for drug substance manufacturing sites (when disclosed in drug product listing fields)
  • CMC sections in NDA supplements (not fully public in an easy list format)

Orange Book status of ZYKADIA: what it implies for supplier identification

Direct answer: Orange Book data can be used to anchor supplier sites by strength, NDC, and listing applicant, but the prompt provides no Orange Book entry details (NDC list, applicant/manufacturer fields, or strength-by-strength mappings), so a supplier name list cannot be produced accurately here.

What Orange Book fields matter for suppliers

• Dosage form
• NDC
• Applicant
• Manufacturer (drug product)
• Labeler

These fields let you map “who makes the finished product” but do not always list all upstream API sources by name.

ZYKADIA sourcing for global markets: does the supplier list change by country?

Direct answer: Yes. Global supply chains commonly differ by:

• local regulatory approvals and qualified manufacturing sites
• import/distribution arrangements
• packaging label requirements

What drives country-to-country changes

• GMP inspection history
• local batch release testing requirements
• distributor-driven warehousing and packaging

ZYKADIA packaging suppliers: who bottles and labels the product?

Direct answer: Packaging and secondary labeling suppliers are typically the “manufactured for” or “packaged by” entities in the US label. Without label text, no accurate supplier list can be compiled.

Packaging configurations that change suppliers

• Bottle vs blister
• blister cartons vs bottle cartons
• strength-specific packaging artwork and labeler codes

How to verify ZYKADIA suppliers for licensing, procurement, or litigation

Direct answer: Supplier verification for ZYKADIA should be tied to FDA label/manufacturer sections and Orange Book drug product listings for each strength/NDC used in procurement. Without those listing identifiers, a supplier roster cannot be produced.

Verification artifacts to use

1. US prescribing information (package insert) for “Manufactured by” / “Packaged by” language by strength.
2. FDA Orange Book entry for each strength/NDC to capture applicant/manufacturer fields.
3. FDA Drug Product Listing (NDC directory) for labeler/manufacturer mapping.
4. DMF-linked API descriptions only when aligned to current commercial batches.

Key Takeaways

• A complete and accurate ZYKADIA supplier list (API and drug product) cannot be generated from the prompt alone because supplier identity must be sourced from FDA label and Orange Book/NDC listings by strength.
• The supply chain breaks into three supplier categories: ceritinib API makers, tablet manufacturing sites (CDMOs), and packagers/secondary-label suppliers.
• Supplier identity can vary by strength and NDC, and can change over time with site transfers and CMC updates.

FAQs

1. What FDA documents list ZYKADIA’s tablet manufacturer by strength?
   Orange Book drug product listings and the US prescribing information “Manufactured by/Packaged by” sections.

2. Does ZYKADIA use one ceritinib API supplier or multiple?
   Multiple API sites can exist across time and batches, but the exact roster must be pulled from approved label/DMF and Orange Book-linked entries.

3. Can procurement rely on NDC-level manufacturer data for ZYKADIA?
   Yes, but only if the NDC is mapped to the correct strength and labeler in the FDA listing.

4. Are ZYKADIA packaging suppliers listed separately from tablet manufacturers?
   Often yes, via label “Packaged by” or “Manufactured for” statements.

5. How does Orange Book help in supplier due diligence for ZYKADIA?
   It anchors the approved drug product listing fields (applicant/manufacturer) at the strength/NDC level used in regulated procurement.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
2. FDA. NDC Directory / Drug Product Listing data. US FDA.
3. FDA. ZYKADIA (ceritinib) Prescribing Information. US FDA label database.