Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: LEVETIRACETAM


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LEVETIRACETAM

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 levetiracetam INJECTABLE;INTRAVENOUS 021872 NDA UCB, Inc. 50474-002-63 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE 2006-08-23
Eugia Pharma LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 204312 ANDA Eugia US LLC 55150-177-05 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-177-05) / 5 mL in 1 VIAL, SINGLE-DOSE 2016-02-01
Fresenius Kabi Usa LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 090876 ANDA Fresenius Kabi USA, LLC 63323-400-05 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01) 2015-08-13
Fresenius Kabi Usa LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 090876 ANDA Fresenius Kabi USA, LLC 63323-400-44 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41) 2015-08-13
Hainan Poly Pharm LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 209781 ANDA TAGI Pharma, Inc. 51224-013-10 10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) / 5 mL in 1 VIAL, SINGLE-USE 2018-11-30
Hainan Poly Pharm LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 209781 ANDA TAGI Pharma, Inc. 51224-013-25 25 VIAL, SINGLE-USE in 1 CARTON (51224-013-25) / 5 mL in 1 VIAL, SINGLE-USE 2018-11-30
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: LEVETIRACETAM

Last updated: April 23, 2026

What Are the Key Pharmaceutical Suppliers for Levetiracetam?

Levetiracetam is manufactured and supplied globally under multiple brand names and numerous generic portfolios. Supplier lists in regulated markets typically track three layers: (1) APIs and intermediates, (2) finished dosage form (FDF) manufacturers, and (3) distribution channels that package and ship finished product to wholesalers, hospitals, and pharmacies. Without a specific country, dosage strength, and dosage form, only a partial supplier set can be stated accurately.

Which companies supply levetiracetam API or API intermediates?

The levetiracetam supply chain includes both captive API manufacturing and specialized API suppliers. The companies below are widely active in levetiracetam production or related API/intermediate manufacturing ecosystems and are commonly referenced in industry supply contexts.

Common API and intermediate supply participants (selected)

  • UCB (originator; U.S. and EU supply footprint through branded and licensed manufacturing)
  • Teva (API and/or FDF supply for generics across multiple markets)
  • Mylan / Viatris (generic levetiracetam manufacturing and supply)
  • Sandoz (generic levetiracetam manufacturing)
  • Dr. Reddy’s (generic levetiracetam manufacturing and supply)
  • Lupin (generic levetiracetam manufacturing and supply)
  • Sun Pharma (generic levetiracetam manufacturing and supply)
  • Alkem (generic levetiracetam manufacturing and supply)
  • Torrent Pharma (generic levetiracetam manufacturing and supply)
  • Amneal (generic levetiracetam manufacturing and supply)
  • Siegfried / Catalent (fill-finish and complex manufacturing capacity used across neuroscience and specialty solids programs in many markets)

These names represent the types of firms that control supply for levetiracetam in many jurisdictions through API, contract manufacturing, or finished product production. The exact “API vs. FDF” role differs by site, regulatory filing, and country listing.

Which companies manufacture and supply finished levetiracetam tablets and extended-release products?

Levetracitam is supplied in several dosage forms that are typically produced by large generic firms plus regional manufacturers: immediate-release tablets, oral solution, and extended-release tablets. In practice, the market supply is dominated by FDF manufacturers that hold ANDA filings (or local registrations elsewhere), then use a network of API suppliers and contract manufacturing organizations to meet volume.

Key finished-dose market participants (selected)

  • UCB (branded supply; also supports licensed manufacturing in certain markets)
  • Teva
  • Viatris (Mylan legacy footprint)
  • Sandoz
  • Dr. Reddy’s
  • Lupin
  • Sun Pharma
  • Alkem
  • Torrent Pharma
  • Amneal
  • Actavis / Allergan legacy group (historically active generic brands in various geographies through successor entities)

For extended-release (XR) products, additional site-specific fill-finish and controlled release formulation capability often comes from specialist manufacturers, depending on the dossier and brand history.

Which distribution channels and “supplier” roles exist for levetiracetam?

In pharma procurement, buyers often encounter three supplier types even when the label says “supplier”:

  1. Manufacturer (site producing tablets/capsules/solution)
  2. Marketing authorization holder (owns the product license and ensures regulatory compliance)
  3. Importer/wholesaler/distributor (handles logistics, warehousing, and market replenishment)

In levetiracetam procurement, a “supplier” may be a distributor even when the underlying manufacturer is a different entity.

How to map levetiracetam supplier selection to regulatory dossiers

In the US, the most actionable supplier mapping comes from the FDA Orange Book entries for levetiracetam products (identified by dosage form, strength, and application holder). That data links the branded/generic holder to the marketed product, which then points procurement teams to likely manufacturing sites through labeling, DSCSA information, and the manufacturing details in the application.

Practical procurement view

  • Use FDA Orange Book to identify the ANDA holder for the exact dosage form/strength.
  • Match the ANDA holder to known production networks (internal manufacturing and contract relationships).
  • Use labeling and DSCSA event data to confirm lot-level supply chain participants.

What supplier footprints dominate levetiracetam demand?

Demand for levetiracetam is broad because it is used across multiple epilepsy subpopulations and in both first-line and adjunct settings. This produces a scale market with high volume and extensive generic competition. The supplier base therefore tends to consolidate around:

  • Large global generic manufacturers with multiple dosage forms
  • Specialists with extended-release or complex oral formulation capabilities
  • Companies with multi-site manufacturing footprint to manage regional supply continuity

Key Takeaways

  • Levetiracetam supply is dominated by major global generic manufacturers plus the originator brand holder.
  • Supplier roles in procurement are often split between marketing authorization holders, product manufacturers, and logistics distributors.
  • For exact supplier identification by product, dosage form, and strength, FDA Orange Book and product labeling are the primary anchors used in regulated sourcing.

FAQs

1) Who is the originator supplier for levetiracetam?
UCB is the originator and a core branded supply participant in many markets.

2) Are levetiracetam suppliers the same across immediate-release and extended-release?
No. Extended-release products can use different formulation and manufacturing processes, which often leads to different fill-finish and controlled-release manufacturing participation.

3) What data source best identifies legal product “holders” for levetiracetam in the US?
The FDA Orange Book identifies approved levetiracetam products and the application holders.

4) Why do buyers see multiple “suppliers” for the same levetiracetam strength?
Because “supplier” can refer to the marketing authorization holder, the manufacturing site, or the distributor/importer depending on the transaction.

5) What supplier types are most relevant for procurement planning?
Manufacturers (site-level), authorization holders (product-level), and distributors (logistics/availability).


References

[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Levetiracetam entries). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] European Medicines Agency. EPAR product information for levetiracetam-containing medicines (branded and generic context). EMA. https://www.ema.europa.eu/

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