Last updated: June 3, 2026
STALEVO 125 is a fixed-dose combination of carbidopa/levodopa/entacapone. The commercial supply chain is built around (1) the manufacturing site(s) producing the finished tablets under the MA holder and (2) upstream API and excipient suppliers that support the manufacturing route. Available public information in regulatory and labeling records does not provide a complete, enumerated list of all named “suppliers” for STALEVO 125 tablets or all upstream vendors by geography.
Who is the marketing authorization holder (MAH) for STALEVO 125?
Direct answer: STALEVO is marketed in the EU under the brand owned by Novartis (Novartis Pharma/Novartis Pharma AG corporate group, depending on country-specific labeling).
Which entities appear on STALEVO 125 labels and cartons?
- Country labeling typically lists:
- MA holder (Novartis entity)
- Manufacturer for the finished product (a specific named manufacturing site, which can vary by country)
- Batch/lot manufacturer (same or different site)
- The “manufacturer” name on the pack is the most reliable public pointer to the finished-product supplier for a specific market.
Which company manufactures STALEVO 125 tablets?
Direct answer: The finished tablets are manufactured at named contract or company sites designated on the local market product label and in the Medicines/EPAR manufacturing sections (varies by country).
What “supplier” means for STALEVO 125 in practice
For procurement and diligence, “supplier” typically splits into:
- Finished dose manufacturer (site releasing the batch)
- API suppliers for:
- carbidopa
- levodopa
- entacapone
- Excipients and coating materials used for the specific tablet strength (125 mg strength corresponds to the fixed-dose ratio used in STALEVO products)
Who supplies the APIs: carbidopa, levodopa, and entacapone?
Direct answer: Carbidopa, levodopa, and entacapone are each sourced from commercial API supply markets. Public sources often show generic lists of API manufacturers at the raw-material level, but do not consistently disclose the named vendor(s) for STALEVO 125 by strength.
API supply patterns used for fixed-dose combinations
- MAH or finished-dose manufacturer typically qualifies one or more API sources per API.
- Qualification can include:
- DMF references (when available)
- GMP inspections
- stability and process validation alignment
- The same API suppliers may serve multiple combinations and dosage forms.
What are the typical sourcing and qualification pathways for STALEVO 125?
Direct answer: The qualification pathway is anchored in regulatory filings and GMP release controls.
EU pathway (common structure)
- EPAR/registration dossier identifies:
- manufacturer(s) for the finished product
- manufacturing processes
- sometimes API sources or the relevant dossier references
- Batch release is performed by the manufacturer or release site shown in local documentation.
US pathway (if evaluated via FDA records)
- Orange Book listing (when applicable) and labeling do not enumerate raw-material vendors.
- DMF access is often not publicly mapped to the exact supplier for each product lot.
Does STALEVO 125 have multiple manufacturing sites by country?
Direct answer: Yes. Fixed-dose brands frequently use more than one finished-product site across markets or through lifecycle changes.
Why site changes matter for supplier diligence
- Different sites can use different excipient suppliers and coating systems.
- Changes can affect:
- dissolution profile
- impurity profile acceptance criteria
- packaging and blister systems
- logistics lead times and regulatory batch traceability
What is the Orange Book status of STALEVO 125, and does it identify suppliers?
Direct answer: Orange Book listings typically identify the branded drug and its manufacturer of record and can list patent-related references, but they do not provide an exhaustive “supplier list” for APIs or excipients.
How to interpret “manufacturer” in FDA listings
- The manufacturer entry is generally the firm responsible for the listed product.
- It is not a full upstream vendor disclosure.
What generic or biosimilar context affects supplier risk for STALEVO 125?
Direct answer: Supplier risk is tied to the competitive landscape and any observed substitution pressures, which can change procurement leverage and raw-material pricing.
How competition impacts sourcing
- API market dynamics for carbidopa, levodopa, and entacapone can tighten during:
- lifecycle transitions
- raw-material supply outages
- regulatory actions against certain sites
- Brands often qualify alternative API sources, but that process is not always visible publicly at the lot level.
Key procurement-ready supplier map for STALEVO 125 (what can be pinned down from public records)
Direct answer: A procurement-grade supplier map for STALEVO 125 requires linking:
- Finished-product manufacturer named on the specific market label/carton
- The MAH responsible for commercial supply
- Qualified API suppliers for carbidopa, levodopa, and entacapone as referenced in dossiers (often via DMF-linked documentation rather than a public “vendor list”)
- Packaging component suppliers are rarely publicly tied to the final product vendor list
What you can reliably use for diligence
- Product label “manufactured by” and address for each market
- Regulatory dossier identifiers (where publicly visible) tied to manufacturing and API source
- Batch release manufacturer in local regulatory documentation
Key Takeaways
- STALEVO 125 tablet supply is anchored by a finished-product manufacturer named on the local product label, typically under the Novartis MAH group.
- Public sources generally do not enumerate all upstream API and excipient vendors for STALEVO 125 by strength and market.
- The most actionable public path to identify suppliers is label-based finished-product manufacturer identification, then dossier-based qualification of API sources for carbidopa, levodopa, and entacapone.
- Supplier diligence for STALEVO 125 should be designed around site-specific batch traceability rather than global “brand supplier” lists.
FAQs
- Does STALEVO 125 use the same tablet manufacturing site in every country?
- Where can I see the finished-product manufacturer for STALEVO 125 for a specific market?
- Are carbidopa, levodopa, and entacapone supplied by the same API vendors across all STALEVO 125 lots?
- Can Orange Book listings confirm the upstream API suppliers used for STALEVO 125?
- What regulatory documentation typically links STALEVO 125 to qualified API sources?
References
(No external sources were successfully extracted in the provided context to support a named supplier list for STALEVO 125.)
