Last updated: June 1, 2026
Zydelig (idelalisib) Suppliers: Who Manufactures, Where Supply Comes From, and What Inputs Drive Availability
Zydelig (idelalisib) supply is tied to a limited set of pharmaceutical manufacturing and packaging organizations that produce the oral solid dose product and to upstream API and critical excipient chains. Downstream “suppliers” in the market typically map to (1) contract manufacturers for dosage-form manufacture and packaging, (2) API manufacturers for idelalisib (and key intermediates), and (3) excipient/packaging suppliers used across oral oncology supply chains.
No complete supplier map can be produced from the information available in this prompt.
What companies supply the API for Zydelig (idelalisib)?
A supplier answer requires the specific idelalisib API manufacturer and any contract API makers tied to Zydelig’s approved NDA labeling and current manufacturing network. Those details are normally confirmed via FDA labeling/manufacturing sections, inspection history, and supplier disclosures in regulatory submissions and batch-release documentation.
Which contract manufacturers make and package Zydelig tablets?
Dosage-form supply is typically split across:
- Drug substance (idelalisib API) and key intermediates
- Drug product manufacture (tablet blending, compression, coating)
- Primary packaging (bottles/blisters)
- Secondary packaging (cartons, labeling, NDC assignment)
A credible supplier list requires the tablet manufacturing and packaging sites shown in Zydelig’s FDA-approved labeling and current manufacturing supplements.
How can Orange Book listings identify Zydelig manufacturing and NDA responsibility?
Orange Book records can confirm:
- NDA holder and marketing authorization
- Drug product strength/route
- Approved application and, in some contexts, manufacturing-site references
A complete supplier mapping depends on the NDA’s labeling “Manufactured for/Distributed by” and “Manufactured by” sections, which must be extracted from the specific marketed product labeling for Zydelig.
What excipient and packaging suppliers support Zydelig oral dosing?
Oral oncology tablets require:
- Film-coating and tablet excipients
- Colors, binders, disintegrants, lubricants
- Primary packaging components that support shelf life and temperature/humidity controls
A supplier list needs the exact formulation composition and packaging configuration used for the currently marketed strengths, then cross-referenced to qualified supplier records.
Who is the primary supply chain owner for Zydelig in the US and EU?
Supply ownership depends on the NDA holder’s manufacturing strategy:
- In-house vs contract manufacturing
- Site ownership vs third-party operations
- Regional distribution arrangements
A definitive answer requires the NDA holder and the specific “Manufactured by” and “Packaged by” statements for each region’s approved labeling.
How do supply constraints or recalls affect Zydelig availability?
Supply risk analysis requires:
- Documented manufacturing outages
- FDA recall notices affecting lot numbers
- Distribution holds tied to inspection outcomes
- Raw-material lead time disruptions
A supplier-focused answer also requires lot-level linkage to the manufacturing/packaging site, which again depends on data not present in this prompt.
Key Takeaways
- “Suppliers for Zydelig” can mean API manufacturers, drug product contract manufacturers, and excipient/packaging vendors.
- A complete, accurate supplier list must be sourced from Zydelig’s current FDA labeling manufacturing sections and linked regulatory records.
- The prompt does not provide enough information to construct a supplier map without risking incorrect company assignments.
FAQs
- Who is listed as the NDA holder for Zydelig in the FDA Orange Book?
- What manufacturing sites are shown in Zydelig’s US FDA-approved labeling for tablet production and packaging?
- Which companies supply idelalisib API used in Zydelig tablets?
- Do Zydelig different strengths use different manufacturing or packaging sites?
- Which FDA recall notices mention Zydelig and identify affected lots/manufacturing sites?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA Prescribing Information for Zydelig (idelalisib), current label revision in the Drugs@FDA database. U.S. Food and Drug Administration.
