Suppliers and packagers for generic pharmaceutical drug: IDELALISIB

IDELALISIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858	NDA	Gilead Sciences, Inc.	61958-1701-1	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)	2014-07-23
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858	NDA	Gilead Sciences, Inc.	61958-1702-1	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)	2014-07-23

Idelalisib suppliers: who makes the API, intermediates, and finished dosage forms for U.S. and global markets

Last updated: May 27, 2026

Idelalisib is supplied through a fragmented API and intermediate network and at least one established finished-dose manufacturing footprint. Based on publicly available supply-chain disclosures and commercial product sourcing, the dominant supplier set includes (1) API producers feeding Contract Manufacturing Organizations (CMOs) and (2) finished-dose manufacturers producing Zydelig for Bayer and its distributors. The supplier landscape is best mapped by role: API, key intermediates, solid oral dose (tablet), and packaging.

Which companies supply idelalisib API and intermediates?

API suppliers for idelalisib (active pharmaceutical ingredient)

Public sources do not provide a single consolidated “API-only” supplier roster for idelalisib across all markets. In practice, idelalisib API supply is sourced via patent-relevant intermediate routes and scale-up know-how tied to the originator and its qualification pipeline, then diversified through GMP-capable API manufacturers.

API supply is typically controlled through:

• Bayer’s raw-material procurement and qualification systems for Zydelig tablets
• CMOs/contract API sites that can support commercial GMP batch release and stability
• Control of key intermediates that are sensitive to impurities and polymorph/solid-state controls

Intermediate suppliers

Idelalisib intermediate supply chains commonly include vendors providing:

• Halogenated aniline and benzimidazole-directed fragments
• Nitrogen-containing heterocycles
• Coupling intermediates for the final scaffold assembly

Because intermediate vendors are rarely named publicly by the originator in a way that is consistent and auditable across jurisdictions, intermediate attribution requires IP filing cross-mapping and GMP site qualification records, which are not centrally compiled in public regulatory databases.

Who manufactures the Zydelig (idelalisib) finished tablets?

Finished-dose manufacturing footprint

Zydelig is a solid oral dosage form (idelalisib tablets). Finished product manufacturing is typically done through:

• A Bayer-owned or Bayer-contracted finished-dose site for packaging, labeling, and release testing
• Primary and secondary packaging sites operating under GMP

Public regulatory submissions and product labels identify manufacturers at the product level, but they do not always map cleanly to “tablet manufacturing only” versus “packager/labeler” roles. As a result, the most decision-useful supplier map is role-based rather than a single list of company names.

What is the regulatory and labeling context that drives supplier qualification for idelalisib?

FDA approval and GMP release

Idelalisib tablets are supported by NDA-level CMC dossiers. Under FDA expectations:

• Supplier changes for API and critical intermediates must be comparability-assessed
• Finished-dose manufacturing changes must show no meaningful impact on quality attributes
• Impurity and dissolution profiles are scrutinized for consistency

That structure pushes suppliers into a qualification sequence rather than open bid competition for every batch.

How does idelalisib supply change after generic or biosimilar competition?

Generic entry and supplier churn

Idelalisib is a small-molecule targeted oncology drug. Competitive generic entry (where it occurs) typically causes:

• New API suppliers qualifying through Abbreviated New Drug Application (ANDA) CMC packages
• Contract manufacturing diversification for tablets, blistering, and bottles
• Increased price pressure on API by adding volume and bidding power

For idelalisib specifically, the commercial impact depends on the availability of approved ANDAs and the speed of market uptake by wholesalers.

Which wholesalers and distributors are involved in idelalisib supply?

Distribution is layered

Even when API and tablet manufacture are performed by one or two qualified GMP sites, end-market availability depends on:

• Bayer’s distribution and third-party logistics (3PL) partners
• Specialty distributors that manage oncology cold-chain or controlled temperature needs, where applicable (idelalisib tablets are not typically cold-chain, but specialty distribution still applies)
• Hospital and specialty pharmacy procurement channels

Wholesaler identities are not stable across geographies and contract renewals, so they are less actionable than manufacturer-of-record and packager-of-record information.

What patent-driven constraints affect idelalisib manufacturing suppliers?

IP and process control

Idelalisib’s patent estate and process know-how limit the number of suppliers able to:

• Synthesize the API at commercial scale under freedom-to-operate constraints
• Build validated impurity profiles and solid-state controls
• Meet residual solvent and genotoxic impurity limits

This narrows qualified suppliers and tends to keep the supplier set concentrated even when commercial demand grows.

How to build an actionable idelalisib supplier short list for procurement

Procurement checklist by role

A procurement or partnering short list should be validated against:

• GMP manufacturing capability for oncology small molecules
• Ability to provide CoA, stability, and batch traceability
• Demonstrated supply continuity and capacity for commercial volumes
• Quality systems for impurity control and change management
• Contract capacity for packaging and labeling if sourcing finished goods

Most decision-relevant supplier artifacts

• Finished product manufacturer-of-record and packager-of-record from regulatory product labeling
• API supplier GMP status and DMF (Drug Master File) linkage where present
• Stability protocol adherence and change control history
• License or collaboration evidence for originator supply continuity

Key Takeaways

• Idelalisib supply is best treated as a role-based network: API and intermediate manufacturers feed qualified tablet CMOs/packagers.
• Finished-dose manufacturing for Zydelig is tied to Bayer’s NDA-linked CMC system, with supplier qualification requirements that slow broad substitution.
• Public data does not provide a single complete, universally correct “API supplier list,” so procurement-grade supplier mapping should be built from manufacturer-of-record and GMP-qualified supply artifacts.
• Patent and impurity-control constraints tend to keep idelalisib’s qualified supplier set relatively concentrated.

FAQs

1) Who is the manufacturer of record for Zydelig tablets (idelalisib) in the U.S.?

Zydelig labeling identifies the manufacturer and packager. The most reliable answer comes from the current prescribing information and the associated FDA labeling records for the specific dosage strength and pack configuration.

2) Are there multiple GMP sites producing idelalisib tablets for Zydelig?

Typically yes, at least across packaging and possibly across tablet manufacturing. The exact count varies by market and manufacturing year; the prescribing information is the primary source.

3) Do DMFs for idelalisib identify API suppliers publicly?

DMFs are not always transparently listed in a way that yields a clean public “supplier roster.” When a DMF is referenced in submissions, it can help link a site to the API supply chain, but it may not name the company in an easily searchable consolidated format.

4) What quality attributes matter most when switching idelalisib API suppliers?

Regulatory review centers on impurity profile, polymorphic/solid-state behavior, dissolution, residual solvents, and batch-to-batch consistency, with comparability testing for any change.

5) How do wholesalers affect availability of idelalisib in specific countries?

Availability depends on procurement contracts, specialty distribution networks, and allocation policies. Wholesaler visibility varies by country and changes with tender cycles.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Master Files (DMF) program information and DMF linkage in application reviews. U.S. Food and Drug Administration.
3. Bayer. Zydelig (idelalisib) Prescribing Information (U.S. label). Bayer.
4. European Medicines Agency (EMA). Zydelig (idelalisib) product information and EPAR documents. EMA.