Share This Page
Suppliers and packagers for XOCOVA
✉ Email this page to a colleague
XOCOVA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Shionogi | XOCOVA | ensitrelvir | TABLET;ORAL | 220442 | NDA | Shionogi Inc. | 59630-711-07 | 1 BLISTER PACK in 1 CARTON (59630-711-07) / 7 TABLET in 1 BLISTER PACK | 2026-07-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for XOCOVA: Which raw-material, contract-manufacturing, and fill-finish vendors can supply the product’s supply chain
Executive summary XOCOVA suppliers break into three buckets: (1) active pharmaceutical ingredient (API) makers, (2) finished-dose and packaging manufacturers (including contract manufacturing organizations, or CMOs), and (3) logistics and regulatory-support vendors that support commercial distribution. No specific supplier roster for XOCOVA (by company name and role) is available in the provided information, so an accurate, company-specific supply-chain mapping cannot be produced.
What companies supply XOCOVA’s API and who manufactures the active ingredient
Featured answer: XOCOVA supplier identification requires mapping the drug’s registered manufacturing sites for API and for drug product; those entities are not provided.
Which API manufacturers typically appear for drugs like XOCOVA
For branded prescription products, the supply chain roster is usually populated by:
- API manufacturers listed on FDA submissions and/or inspections
- Drug product manufacturers listed on the label and in FDA records (NDA/BLA/ANDA supplements)
- Secondary packaging and kit assembly vendors for multi-component products
What to extract from regulatory records to identify API suppliers
A defensible supplier list is usually derived from:
- Drug label “manufactured for/ by” statements
- FDA establishment listings tied to the marketing application
- Site-specific inspection outcomes and manufacturing authorization links
Which CMOs make XOCOVA finished dosage forms and where are they located
Featured answer: Finished-dose manufacturing suppliers for XOCOVA are not stated in the provided information.
Drug product manufacturing roles that determine “supplier” status
“Supplier” can mean different roles in commercialization:
- Tablet/capsule manufacturing (blending, granulation, compression)
- Liquid manufacturing (mixing, filling, aseptic or terminal sterilization)
- Packaging and labeling (secondary packaging, unit-of-use configuration)
- Specialty manufacturing (controlled room temperature and cold-chain operations)
How contract manufacturing is typically structured
Most branded drugs rely on one or more:
- Primary drug product CMO (DS manufacturing)
- Final fill-finish site (DP manufacturing, if applicable)
- Packaging site(s) for cartons and unit labels
Who provides fill-finish services for XOCOVA (bottles, blisters, syringes)
Featured answer: Fill-finish suppliers for XOCOVA are not provided.
Packaging configuration drives the vendor list
Supplier discovery depends on the marketed presentation:
- Blister packaging usually involves blister lines and cartoning equipment at one or more sites
- Bottled presentations require container sourcing plus label printing and packing operations
- Injectable presentations add additional sterile processing and extractables/leachables control suppliers
How does XOCOVA procurement work: single-source vs multi-source supplier networks
Featured answer: Single-source versus multi-source network design is not determinable from the provided information.
What multi-sourcing generally looks like
When supply risk is managed, commercial networks usually include:
- Alternate drug product sites
- Backup packaging lines
- Dual API sourcing with qualified change control
What creates supplier constraints
Supplier concentration increases risk when there is:
- Highly specialized equipment (sterile filling, aseptic filling)
- Tight impurity specs for API
- Regulatory constraints on site changes
Which vendors support XOCOVA distribution, cold-chain logistics, and warehousing
Featured answer: Distribution logistics vendors for XOCOVA are not provided.
Typical logistics supplier categories
- Wholesaler/distributor or 3PL network operators
- Temperature monitoring and compliance service providers
- Reverse logistics for returns and recalls
What evidence is required to list XOCOVA suppliers correctly
Featured answer: A correct supplier list requires linkable evidence from FDA and labeling records; none is included here.
Evidence sources used in supplier mapping
- US FDA establishment inspection and manufacturing site data
- FDA labeling “manufactured for” statements
- Sponsoring NDA/ANDA manufacturing arrangements
Key Takeaways
- A company-specific supplier roster for XOCOVA cannot be produced from the information provided.
- Accurate supplier mapping requires FDA/label-derived manufacturing site data for API, drug product, and packaging, plus role-specific identification for fill-finish and distribution.
FAQs
- What information in XOCOVA’s FDA records identifies the drug product manufacturing site?
- How do I determine the API supplier for a brand when multiple vendors are involved in the supply chain?
- Do XOCOVA packaging suppliers appear on the label, or only in FDA manufacturing listings?
- What roles count as “suppliers” for procurement, quality agreements, and change control for XOCOVA?
- How can I map XOCOVA’s supply chain risk if the product uses a single fill-finish site?
References
- FDA. Drug Establishment Registration and Listing. US Food and Drug Administration. https://www.fda.gov/drugs/drug-establishment-registration-and-listing
More… ↓
