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Suppliers and packagers for KEPPRA XR
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KEPPRA XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285 | NDA | UCB, Inc. | 50474-598-66 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66) | 2008-09-24 |
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285 | NDA | UCB, Inc. | 50474-599-66 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66) | 2009-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for KEPPRA XR
Who Supplies Keppra XR?
Keppra XR (extended-release levetiracetam) is a prescription antiepileptic drug distributed in the US under UCB (UCB Pharma) brand ownership, with Mylan’s US regulatory footprint historically tied to Keppra XR product filings. The supply chain structure depends on the regulatory “applicant”/labeler for the specific market and the manufacturing site(s) listed on approved submissions.
What is the branded product and who is the labeler?
Keppra XR = extended-release levetiracetam. In the US, the branded product is marketed under UCB’s brand umbrella (UCB is the labeler/brand owner in common US drug databases for Keppra XR).
Regulatory/applicant history in the US: Mylan has appeared as an applicant/filing entity for Keppra XR in US regulatory records tied to product submissions (this does not automatically mean Mylan manufactures drug substance or finished dose; it indicates the submission/applicant footprint used for approvals and/or product support in those filings).
What roles do suppliers play in Keppra XR supply?
For a branded oral solid extended-release product like Keppra XR, “suppliers” typically break into two operational layers:
- Regulatory/brand labeler (who the market identifies on-pack)
- Manufacturing network (who makes drug substance and drug product)
- Finished-dose manufacturing sites
- Often separate drug substance (active pharmaceutical ingredient, API) suppliers
- Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) for solid oral dosage forms
Which entities are linked to Keppra XR in US regulatory/market records?
The supply list below is limited to entities that show up in authoritative US product labeling and regulatory databases for Keppra XR.
Labeler / brand owner
- UCB (brand owner/labeler footprint for Keppra XR in the US)
US regulatory/applicant footprint
- Mylan (appears in US regulatory product filing context for Keppra XR)
The practical takeaway: in procurement and manufacturing due diligence, you start with the labeler (UCB) for brand-level accountability, then map the applicant’s submission packages to the site list (API and finished dose manufacturing addresses) that show up in the approvals.
What manufacturing sites matter for procurement?
For Keppra XR, supplier selection in R&D sourcing or investment due diligence typically targets the specific manufacturing step(s) that affect:
- Extended-release formulation performance (release profile depends on excipient system and tablet matrix)
- Scale-up and process robustness (crucial for solid oral ER)
- Regulatory compliance (site-specific cGMP status)
In practice, the definitive supplier list is the one tied to:
- Approved application manufacturing site(s) (drug substance and drug product)
- Current Good Manufacturing Practice (cGMP) inspection history
- Quality agreements between labeler, API supplier, and CMO
How to interpret “supplier” for Keppra XR in business terms
When a buyer asks “suppliers,” the question can mean different things. For Keppra XR, the actionable interpretation is:
- Who owns the marketed product and supply commitments?
- UCB as labeler/brand owner footprint.
- Who is tied to the regulatory product submission history (and therefore the likely approval-linked manufacturing site list)?
- Mylan appears in the US regulatory applicant footprint.
- Who physically makes the tablets and API at approved sites?
- These are determined by the specific manufacturing sites listed in approved filings (site-level supplier roster), which is where procurement teams focus next.
Keppra XR supplier map (market-level vs regulatory-level)
| Supplier type | Entity shown in US product/regulatory footprint | What it controls in practice |
|---|---|---|
| Brand labeler / market identity | UCB | Label ownership, brand-level supply and quality accountability |
| Regulatory applicant footprint | Mylan | Submission-linked manufacturing site list and product-support documentation |
| Manufacturing sites (API + finished dose) | Not enumerated here from site tables | Determined from the approved application’s manufacturing section for Keppra XR |
Key supplier-driven diligence items for Keppra XR
Even without listing every plant address, the supply-chain diligence checklist for Keppra XR should map to the following:
- API source continuity (levetiracetam drug substance supplier)
- ER dose manufacturing (tablet press, coating, extended-release technology step)
- Batch disposition and release testing (site responsibility)
- Change control history on ER excipients and manufacturing parameters
- Regulatory inspection status of the finished dose site
Key Takeaways
- Keppra XR (extended-release levetiracetam) is a UCB-marketed branded product in the US.
- Mylan appears in the US regulatory applicant footprint for Keppra XR filings.
- The complete “who makes it” supplier list depends on the approved application manufacturing site(s) for Keppra XR, separating API and finished-dose manufacturing roles.
FAQs
1. Is UCB the supplier of Keppra XR?
UCB is the brand labeler/owner footprint for Keppra XR in the US drug product context.
2. Is Mylan a manufacturer of Keppra XR?
Mylan is shown in the US regulatory applicant footprint for Keppra XR filings; applicant status does not by itself prove finished-dose or API manufacturing.
3. Who provides the levetiracetam extended-release tablets?
The tablets are produced at the approved finished-dose manufacturing site(s) listed in the Keppra XR approval package; supplier-by-plant identification comes from those site listings.
4. Are the API and tablet suppliers the same?
Typically, API and finished-dose suppliers are separate in branded ER supply chains unless the approval shows a single integrated manufacturer.
5. Where should a procurement team confirm “the real suppliers”?
Confirm via the approved application manufacturing sections tied to the brand product labeler and submission applicant footprint, then validate via cGMP and quality agreements.
References
[1] DailyMed. “Keppra XR (levetiracetam) extended-release tablets.” US National Library of Medicine. https://dailymed.nlm.nih.gov/
[2] Drugs@FDA. “Keppra XR.” US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
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