Last updated: June 4, 2026
STALEVO 50 (carbidopa/levodopa/entacapone) is a prescription, fixed-dose combination marketed in multiple geographies with supply anchored to the original product’s branded commercialization and licensed/contract manufacturing for finished tablets. Supplier selection in practice is split between (1) brand commercialization entities that control release/distribution and (2) contract manufacturing and API supply that feed tablet production.
Who supplies STALEVO 50 (carbidopa/levodopa/entacapone) in major markets?
Primary commercial suppliers depend on country-specific marketing authorizations and distribution networks. The brand’s supply chain typically includes:
- Brand owner or marketing authorization holder distributing finished product to wholesalers
- Contract manufacturers producing tablets under quality agreements
- API suppliers for carbidopa, levodopa, and entacapone (and intermediates) feeding tablet manufacture
How is STALEVO 50 distributed (typical channel structure)?
- Centralized release and distribution by the marketing authorization holder or regional affiliate.
- National wholesaler networks for hospitals and retail pharmacies.
- Parallel channels in some markets, driven by pricing and regulatory equivalence.
Which tablet strengths matter for sourcing?
STALEVO’s “50” strength corresponds to a fixed-dose composition used in titration regimens. Sourcing is therefore tied to the same licensed finished-dose tablet design and manufacturing process, with logistics and regulatory batch release tied to that strength.
Which companies manufacture STALEVO tablets under contract?
Finished-dose supply is generally produced under GMP agreements by contract manufacturers and/or internal manufacturing sites tied to the brand’s quality system. For STALEVO, finished-dose tablets are made by manufacturers selected by the marketing authorization holder and listed in regulatory files in each jurisdiction.
What to map when identifying STALEVO 50 finished-dose suppliers
- Tablet site manufacturing locations (GMP sites) on the marketing authorization
- Batch release site in the country of sale
- Packaging configuration for the 50 strength
Key manufacturing/IP considerations that constrain supplier substitution
- Tablet formulation and process parameters validated for dissolution and stability
- Three-API compatibility and manufacturing sequencing
- Cross-site comparability requirements if supply shifts
Where do carbidopa, levodopa, and entacapone suppliers come from?
API supply for STALEVO 50 typically uses qualified upstream manufacturers for each active ingredient:
- Carbidopa (API)
- Levodopa (API)
- Entacapone (API)
What upstream categories feed STALEVO API supply?
- Carbidopa API produced via established synthetic routes with impurity profiles controlled to meet pharmacopeial and regulatory specifications.
- Levodopa API with tight control on oxidation and degradation products.
- Entacapone API with specific nitroaromatic intermediate controls and polymorphic control where applicable.
Supplier qualification gate for drug-device and tablet combination stability
Even when API sourcing is interchangeable in principle, the following drive actual supplier qualification:
- Demonstrated equivalence to reference API specs in the branded product
- Impurity profile similarity across suppliers
- Stability and dissolution impact at finished-dose level
What is the Orange Book status of STALEVO 50 and how does it affect sourcing?
STALEVO 50 is the marketed brand product; generic availability depends on whether the combination is protected by active patents and exclusivity in the specific jurisdiction (for the US, Orange Book listings). Where combination exclusivity and patents remain active, sourcing will be dominated by the brand’s supply chain and authorized licenses.
How exclusivity translates into supplier concentration
- If no authorized generic or direct-combination generic exists, the market has limited finished-dose sources.
- If generics exist in some countries but not others, supplier diversity increases regionally, while API availability remains the same constraint.
What generic entry risks change STALEVO 50 supply?
Supply risk shifts when authorized generics or combination generics enter:
- More finished-dose manufacturing sites compete on price and logistics
- Wholesalers may favor alternative suppliers to manage procurement cost and availability
- API suppliers may broaden since finished-dose manufacturers place larger orders
Where procurement can break
- Tablet-specific manufacturing outages at the dominant site
- API production stoppages for one of the three actives
- Regulatory batch release delays in the importing market
Practical procurement view: how to identify the real suppliers for STALEVO 50 batches
In procurement and QA, “supplier” must be understood as one of three entities:
- Finished-dose manufacturer (GMP site that made the tablets)
- Marketing authorization holder/distributor (who ships and releases product into the country)
- API manufacturer(s) named in regulatory and DMF systems (upstream)
Best-fit documents used in supply qualification
- Certificate of Analysis with manufacturing site and batch details
- Country-specific package insert and regulatory labeling
- GMP certificate and QMS agreement documents provided by the distributor/MAH
- If required, DMF or cross-reference confirmations through regulatory partners
Timeline: when supply tightness usually emerges
Supply tightness generally follows one of four triggers:
- Market authorization changes (site change notifications)
- Global API supply disruptions for carbidopa or entacapone
- Finished-dose line constraints during demand spikes
- Safety stock depletion and lead-time extensions for tablet packaging
Typical lead-time dynamics for fixed-dose combinations
- Finished-dose tablets: longer lead times if single-site production dominates
- APIs: shorter in theory, but constrained by qualification for the final combination
Key takeaways
- STALEVO 50 supply is anchored by the brand’s marketing authorization holder and the finished-dose GMP manufacturers producing the specific tablet strength.
- Upstream API sourcing for carbidopa, levodopa, and entacapone is qualified to support the branded finished-dose specifications and stability profile.
- Supplier substitution risks are driven by finished-dose process validation and impurity/spec alignment at the API level.
- Procurement should identify supplier roles separately: finished-dose GMP site, distributor/MAH, and upstream API manufacturer(s).
FAQs
1) How can I confirm the manufacturer of STALEVO 50 for a specific batch?
Use the batch-specific Certificate of Analysis and the labeled manufacturing site on the commercial package.
2) Are carbidopa/levodopa/entacapone suppliers interchangeable for STALEVO 50?
They are only used interchangeably after qualification that supports branded finished-dose specifications, including impurity profile and stability/dissolution performance.
3) What typically causes STALEVO 50 shortages?
Finished-dose manufacturing line constraints, upstream API supply interruptions for one of the three actives, and regulatory batch release delays.
4) Does the existence of generics change STALEVO 50 supply reliability?
In markets where combination generics are available, supply diversity usually increases and procurement risk decreases; in markets without generics, the brand supply chain remains dominant.
5) What documentation is required to qualify a new STALEVO 50 supplier?
GMP and QMS agreements, CoA review with batch linkage, and evidence that manufacturing site and release testing meet the branded finished-dose specifications.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- EMA. European Public Assessment Reports (EPAR) for Stalevo and related variations. European Medicines Agency.
- USP. United States Pharmacopeia. General Chapters and monographs relevant to carbidopa, levodopa, entacapone, and tablets.
