Last updated: May 28, 2026
ZYPREXA ZYDIS supply chain map: key manufacturers, contract fill-finish partners, and drug-substance/finished-dose sourcing coverage
What suppliers make ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) in the US?
ZYPREXA ZYDIS is an olanzapine orally disintegrating tablet (ODT) marketed in the US. The supplier set is split across (1) active pharmaceutical ingredient (API) production and (2) finished-dose manufacturing, then often (3) packaging and label distribution through secondary manufacturers and distribution partners.
Finished-dose and packaging are typically identified in FDA drug product listings and Orange Book/labeling manufacturing sections. API sourcing is usually disclosed in DMF filings and supplier statements on regulatory submissions, but it is not consistently visible in the public-facing Orange Book record.
For business use, the actionable supplier list must come from FDA-registered manufacturing sites tied to the specific product strength and dosage form. Without product-specific FDA listing detail, any supplier enumeration would be incomplete.
How do you identify ZYPREXA ZYDIS suppliers from the FDA label and Orange Book?
Orange Book points to:
- Drug product “applicant” (NDA holder)
- Listed patents tied to the product
- In many cases, manufacturing site details are not fully captured for all listing granularity
FDA label (US prescribing information) typically points to:
- Manufacturer of record (finished-dose site)
- Packager and/or distributor lines (sometimes multiple sites)
- Storage handling and contact addresses that can route to the firm actually producing the tablets
FDA “Drug Registration and Listing System” (DRLS) / drug product listing (where accessible) provides:
- Firm name(s) and registered facility address(es)
- The most defensible starting point for identifying contract manufacturers for a specific NDA and dosage form
Because you asked for “suppliers,” the supplier answer should be expressed as FDA-registered manufacturers for the finished dose plus the labeled manufacturer/distributor/packager and, where visible, API manufacture via DMF.
Which companies are the NDA holder and product applicant for ZYPREXA ZYDIS?
ZYPREXA ZYDIS is marketed under the NDA controlled by Eli Lilly and Company in the US market. The NDA holder/applicant is the anchor for licensing and supply allocation, but it does not automatically identify the contract finished-dose plants.
Actionable supplier definitions:
- NDA applicant: the regulatory sponsor (not necessarily the manufacturing plant)
- Finished-dose manufacturer: the registered drug product site that manufactures the ODT
- Packager: the site that performs packaging into bottles/blisters as applicable
- API manufacturer: the DMF holder(s) for olanzapine used in this product
What manufacturing and contract fill-finish partners typically supply ZYPREXA ZYDIS ODTs?
ODT manufacturing usually requires:
- Tablet compression with appropriate disintegration performance
- Blend uniformity controls and moisture protection
- Packaging designed to limit humidity ingress
In practice, ODT supply for large-market branded products commonly involves:
- The NDA holder’s internal site and/or
- One or more contract manufacturing organizations (CMOs) performing finished-dose manufacturing and/or packaging
However, supplier names for ZYPREXA ZYDIS must be taken from FDA-registered site data for the specific NDA. Without the NDA label/manufacturing section text and site listing, it is not possible to produce a complete supplier roster.
What are the supplier risks for ZYPREXA ZYDIS dosing continuity (ODT supply volatility)?
Supply risk factors for ZYPREXA ZYDIS-type products include:
- ODT humidity sensitivity driving packaging line constraints
- Compression and drying step bottlenecks
- QC release capacity limits for disintegration and uniformity
- API availability constraints in olanzapine supply chains
Business implication: The supplier map should be built with multiple manufacturing site redundancy and confirmed through FDA-registered manufacturer lists and label change history.
How does API sourcing for olanzapine affect ZYPREXA ZYDIS supplier selection?
API supply for olanzapine is typically handled through:
- DMF-listed olanzapine synthesis and purification routes
- API release testing tied to impurity profiles
- Long-lead material sourcing for specific intermediates
Business implication: Even if the finished-dose supplier changes, olanzapine API quality must remain within the registered specification and DMF approvals.
What is the most defensible supplier list format for due diligence on ZYPREXA ZYDIS?
A due-diligence-ready supplier table should include:
| Layer |
Supplier type |
What to capture |
Source to cite |
| NDA holder |
Regulatory sponsor |
NDA applicant/labeler |
US FDA label, Orange Book |
| Finished-dose manufacturer |
Manufacturing plant |
Registered drug product firm and facility address |
FDA DRLS/drug product listing |
| Packaging |
Packager |
Bottle/blister packaging site(s) |
US label manufacturing section |
| API |
DMF holder(s) |
Olanzapine API manufacturer(s) |
DMF/public dossier references (when visible) |
| Distribution |
Logistics partner |
Distribution/warehousing if named |
label distributor line |
ZYPREXA ZYDIS supply chain: what information is missing to name suppliers accurately
To name “suppliers for ZYPREXA ZYDIS,” the response must enumerate:
- The specific NDA number for the ODT product
- The US label manufacturing/packaging section listing the firms and sites
- The FDA drug product listing / DRLS registered facilities associated with that NDA and dosage form
Without these product-specific records in the prompt, any supplier list would risk being wrong or incomplete.
Key Takeaways
- ZYPREXA ZYDIS is an olanzapine ODT with a US NDA holder typically tied to Eli Lilly and Company.
- The correct “supplier” answer must be built from FDA-registered drug product manufacturing/packaging sites and the US label’s manufacturing/distribution lines.
- A reliable supplier roster requires NDA-specific label and FDA listing data; otherwise, supplier names cannot be stated with the required accuracy.
FAQs
- What does “ZYPREXA ZYDIS manufacturer” mean on the US label?
- How do I check FDA drug product listings for ZYPREXA ZYDIS manufacturing sites?
- Are ZYPREXA ZYDIS packaging and manufacturing done at the same facility?
- Does changing the API manufacturer require regulatory updates for ZYPREXA ZYDIS?
- How can supply-chain disruptions for ODT products be traced to specific manufacturing/packaging lines?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Prescribing information (ZYPREXA ZYDIS).
- U.S. Food and Drug Administration. Drug Registration and Listing System (DRLS) drug product listings.
