Last updated: April 23, 2026
Who makes the tablets under STALEVO 100?
STALEVO 100 is a combination of levodopa, carbidopa, and entacapone formulated as a tablet product. The branded product is distributed by Orion Pharma (marketed under the STALEVO brand). The branded manufacturing footprint varies by market and can be held by different contract manufacturers and/or group companies through regional supply agreements. Public label and regulatory dossiers tied to EU and other jurisdictions typically identify the applicant/MAH and the manufacturing sites for finished product and batch release.
Core branded product structure (active ingredients)
- Levodopa
- Carbidopa
- Entacapone
(These define STALEVO’s supply chain for API procurement and finished dosage form manufacture.)
What are the confirmed supplier categories for STALEVO 100?
For a combination tablet like STALEVO 100, supply chain inputs break down into three layers:
-
APIs
- Levodopa (API)
- Carbidopa (API)
- Entacapone (API)
-
Finished dosage form manufacturing
- Tablet manufacturing (blending, granulation, compression)
- Tablet coating and packing
-
Quality and batch release
- Batch certification/release at specific manufacturing sites listed on the marketing authorization documentation
Which companies appear in public regulatory labeling for STALEVO manufacturing?
Publicly accessible regulatory documentation for STALEVO (EU-style product information and associated manufacturing sections) generally points to:
- The Marketing Authorisation Holder (MAH): Orion Corporation / Orion Pharma (varies by region naming).
- One or more manufacturing sites for:
- Finished product (tablets)
- Secondary packaging
- Batch release
However, market-specific labeling controls what name appears on the outside carton and what manufacturing sites are listed. Without a specific jurisdiction (country or MA number) and packaging strength confirmation beyond “100,” supplier names can’t be stated with patent-grade precision.
What suppliers should be expected for the APIs (standard industry pattern)?
For levodopa/carbidopa/entacapone combinations, the supply chain typically includes:
- API suppliers that sell to the MAH or to contract manufacturers
- Finished-dose contract manufacturers that produce tablets and perform packaging
- Specialty quality release performed at the site listed for batch certification
To name suppliers as specific legal entities for STALEVO 100, you must rely on jurisdiction-specific product information and dossier data that list manufacturing sites and MAH-controlled manufacturing authorizations.
What can be asserted for STALEVO 100 without market-specific label data?
The following can be asserted from STALEVO’s branded positioning and combination chemistry:
- Orion Pharma is the brand owner/distributor for STALEVO.
- STALEVO 100 requires three API supply lines: levodopa, carbidopa, entacapone.
- Finished tablet supply is produced through authorized manufacturing sites named on the marketing authorization for each jurisdiction.
Where does a business typically find the supplier names (and why they differ)?
Supplier naming differs by:
- Country (UK, DE, FR, ES, IT, Nordics, etc.)
- Regulatory type (brand packaging, parallel import listings)
- Manufacturer site changes over time (GMP site refresh, scale-up, outsourcing)
The practical method is to read the local product leaflet/summary that lists:
- MAH/applicant
- Manufacturer and packing sites
- Batch release location
Because you did not specify a jurisdiction or the exact regulatory product identifier tied to your “STALEVO 100” pack, the only safe, accurate supplier statement is at the MAH level and by ingredient category.
Key Takeaways
- STALEVO 100 is an Orion-branded combination tablet of levodopa, carbidopa, entacapone.
- Supplier structure has three layers: API suppliers, finished-dose manufacturers, and batch release/QP-certified sites.
- Finished-product supplier names are jurisdiction- and pack-dependent; they are determined by the local approved manufacturing sites listed in the product information.
FAQs
1) Who supplies STALEVO 100 to markets?
The brand is distributed/held under Orion Pharma through market-specific marketing authorizations.
2) What are the key input APIs for STALEVO 100?
Levodopa, carbidopa, and entacapone.
3) Are the contract manufacturers the same across countries?
No. Finished-dose and packaging sites can change by country labeling and approved GMP site authorizations.
4) How do you identify the exact tablet manufacturing supplier?
Use the local product information leaflet/SmPC section listing the manufacturer and batch release sites for that specific pack and strength.
5) Do API suppliers show up on the carton?
Usually not. API suppliers are typically not listed publicly; they are reflected in dossiers and supply chain documentation rather than consumer labeling.
References
[1] EMA. European public assessment reports and product information documents for medicinal products (STALEVO pages and associated EPAR/SmPC/manufacturing sections). European Medicines Agency. https://www.ema.europa.eu/
[2] Orion Pharma. STALEVO product information and brand documentation (Orion brand ownership and distribution context). https://www.orionpharma.com/
[3] UK MHRA. Medicines product information and manufacturing site references for branded products (where available by pack/strength). https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
