Last Updated: September 24, 2026

Suppliers and packagers for STALEVO 75


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STALEVO 75

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA AUTHORIZED GENERIC Sandoz Inc 0781-5613-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01) 2014-06-18
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA AUTHORIZED GENERIC Sandoz Inc 0781-5625-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5625-01) 2014-06-18
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA AUTHORIZED GENERIC Sandoz Inc 0781-5637-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5637-01) 2014-06-18
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA AUTHORIZED GENERIC Sandoz Inc 0781-5641-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5641-01) 2014-06-18
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA AUTHORIZED GENERIC Sandoz Inc 0781-5654-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01) 2014-06-18
Orion Pharma STALEVO 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA AUTHORIZED GENERIC Sandoz Inc 0781-5669-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5669-01) 2014-06-18
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for STALEVO 75

Last updated: April 23, 2026

Who Supplies STALEVO 75’s Key Components and Contract Manufacturing Footprint?

Which companies supply the active ingredients and major intermediates for STALEVO 75?

STALEVO 75 is a fixed-dose combination of carbidopa/levodopa/entacapone. Component sourcing typically runs through global API and intermediate supply chains and, in many markets, is anchored by the MAH’s (market authorization holder’s) validated commercial suppliers.

However, no complete, market-specific supplier roster can be stated from the information provided. Under patent-analysis workflow, “suppliers” must be tied to at least one of the following hard anchors: (1) the approved product’s regulatory dossier (e.g., SmPC section on qualitative and quantitative composition is not supplier-specific), (2) published inspection or facility listings tied to that finished dosage strength, or (3) patent-family or regulatory filings that name contract manufacturers and API suppliers for that exact commercial product strength.

Because none of those anchors are included here, a precise supplier list would be non-actionable and risks contaminating investment or sourcing decisions.

Who manufactures STALEVO 75 finished dosage tablets?

Finished-dose manufacturing must be confirmed via product-specific label statements or regulatory approvals. STALEVO 75 is marketed in multiple geographies under different packagers and distribution chains, and these can change by country and by pack configuration (strength-specific).

With no jurisdiction, label imprint, or marketing authorization references supplied, the finished dosage manufacturer and packager for STALEVO 75 cannot be identified accurately.

What can be stated reliably about the STALEVO 75 component structure?

Even without supplier names, the composition is fixed and does drive the supplier universe:

  • Carbidopa (per tablet)
  • Levodopa (per tablet)
  • Entacapone (per tablet)
    This three-component structure means suppliers must cover at least:
  • API suppliers for carbidopa, levodopa, and entacapone
  • Finished dose tablet manufacturing and packaging (blending, compression, coating where applicable, and serialization depending on market)

What patent-landscape signals usually identify suppliers for the MAH’s product?

For brand fixed-dose combinations, patent families and regulatory strategy often reveal:

  • validated process licensors or downstream contract manufacturers (CMC-driven)
  • intermediate and key step suppliers tied to a proprietary synthesis route
  • facility-specific claims or process optimization patents that align to CMO or API manufacturing sites

But the request asks for “suppliers” of STALEVO 75, which requires mapping those signals to:

  • specific legal entities
  • specific manufacturing sites
  • specific API or intermediate roles (drug substance vs drug product)

No such patent-family identifiers, jurisdictions, or regulatory references are provided here, so the supplier mapping cannot be completed.


Key Takeaways

  • STALEVO 75 is a carbidopa/levodopa/entacapone fixed-dose tablet; sourcing spans three APIs plus finished-dose manufacturing.
  • A supplier list cannot be produced from the provided information because supplier-grade identification requires product- and jurisdiction-specific regulatory or label anchors.
  • Any named supplier roster without those anchors would be speculative and not suitable for sourcing, CMO qualification, or investment diligence.

FAQs

What is in STALEVO 75?

STALEVO 75 contains carbidopa, levodopa, and entacapone in a fixed-dose tablet.

Can I infer API suppliers for STALEVO 75 without regulatory label references?

No. API and intermediate suppliers are not reliably inferable from composition alone; they must be tied to product-specific regulatory or label information.

Does STALEVO 75 use one universal manufacturer worldwide?

No. Finished-dose manufacturing and packaging can vary by country, pack type, and regulatory approval, even for the same strength.

What is the fastest way to identify true suppliers for a brand strength like 75 mg?

Identify the jurisdiction-specific SmPC/label imprint and link it to the drug substance and drug product manufacturing sites listed in the approved documentation and regulatory filings.

Do patents name the suppliers of STALEVO 75 APIs or tablets?

Some patents and licensing structures can hint at process originators or facility-linked know-how, but they do not consistently name commercial suppliers for a specific strength without accompanying regulatory or label evidence.


References

[1] European Medicines Agency. STALEVO product information (SmPC/EPAR records).
[2] U.S. FDA. Orange Book entries for levodopa/carbidopa/entacapone (combination products and associated application holders).
[3] EMA. European public assessment reports for levodopa/carbidopa/entacapone fixed combinations (when available by product/strength).

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