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Suppliers and packagers for SINEMET
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SINEMET
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555 | NDA | Organon LLC | 78206-166-01 | 100 TABLET in 1 BOTTLE (78206-166-01) | 2021-06-01 |
| Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555 | NDA | Organon LLC | 78206-167-01 | 100 TABLET in 1 BOTTLE (78206-167-01) | 2021-06-01 |
| Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555 | NDA | Organon LLC | 78206-168-01 | 100 TABLET in 1 BOTTLE (78206-168-01) | 2021-06-01 |
| Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555 | NDA | Organon LLC | 78206-190-01 | 100 TABLET in 1 BOTTLE (78206-190-01) | 2025-02-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for SINEMET
Who Supplies SINEMET? Key Upstream Players in Manufacture, Distribution, and Change-Control
SINEMET is the brand name for carbidopa/levodopa (immediate-release and related formulations). “Suppliers” can mean multiple things in the pharma value chain. The market-facing supply chain typically includes the marketing authorization holder/manufacturer for the drug product, plus API and excipient sourcing, and logistics/distribution. For SINEMET, the drug is supplied in the US under a defined manufacturer/labeler model, and key upstream supply often varies by site, strength, and dosage form.
What entity supplies SINEMET to the market (US labeler/manufacturer)?
In the US, SINEMET is marketed and labeled under the AbbVie business (historically through legacy pharma ownership of the brand and manufacturing/labeling rights). The drug product is manufactured at FDA-registered facilities and distributed through standard pharma distribution channels.
Market-facing supplier (US):
- AbbVie (brand owner/labeler for SINEMET in the US)
Where to verify the exact manufacturer for the specific strength/formulation:
- FDA systems that list labeler/manufacturer for each National Drug Code (NDC) include:
- Drugs@FDA
- FDA NDC Directory
These tools are the authoritative mapping from NDC → labeler/manufacturer.
| Item | What it identifies | Where it is verified |
|---|---|---|
| Labeler/Manufacturer | The entity responsible on the label for a specific NDC | FDA NDC Directory, Drugs@FDA |
| Site/manufacturing controls | The registered manufacturing site tied to that NDC | FDA inspection/registration records and NDA/ANDA manufacturing info via Drugs@FDA |
Who supplies the APIs for carbidopa and levodopa?
SINEMET is built on two active pharmaceutical ingredients:
- Carbidopa (API)
- Levodopa (API)
API “supplier” changes over time due to site qualification, quality agreements, and sourcing economics. The enforceable supplier relationship for due diligence is usually captured via:
- FDA DMFs (Drug Master Files) for API manufacturing know-how and processing controls
- NDA listing that ties the API and processes to registered manufacturing sites (when disclosed)
Practical supplier mapping method (API level):
- Search for carbidopa DMFs and levodopa DMFs in FDA’s public DMF index, then cross-check who is named and which facilities are referenced.
- Link those DMFs to the branded product via the NDA/approval dossier summary and current product manufacturing references in Drugs@FDA.
| API | What to map for suppliers | Public source used |
|---|---|---|
| Carbidopa | DMF holder and manufacturing sites | FDA DMF listings/index (where available) |
| Levodopa | DMF holder and manufacturing sites | FDA DMF listings/index (where available) |
Who supplies key excipients for SINEMET tablets?
Tablet excipient suppliers generally vary by formulation variant and manufacturing site. In practice, excipient supply is governed by:
- Approved formulation in the NDA/BLA submission
- GMP controls and supplier qualification in the manufacturing quality agreement
Because excipient sourcing is not consistently disclosed at the same granularity as API, the most defensible way to identify excipient suppliers is to:
- Obtain the formulation/excipient list for each strength/formulation
- Then map those excipients to supplier qualification lists, which are typically internal to manufacturers
Publicly verifiable excipient information:
- The approved excipient list is typically visible in the label (US prescribing information) and/or FDA review summaries through Drugs@FDA.
How do you identify the real “supplier” for a specific SINEMET product variant?
A SINEMET labeler/manufacturer relationship is best validated at the NDC level. SINEMET is not one SKU. It is multiple strengths and often multiple dosage forms, each with its own NDC, which can correspond to different manufacturing sites.
Actionable workflow used by diligence teams:
- Pick the strength/dosage form (e.g., immediate-release tablet strength).
- Pull the NDC from packaging or NDC listing.
- Use FDA NDC Directory to extract:
- Labeler
- Manufacturer
- Repackager (if applicable)
- Use Drugs@FDA to confirm the product’s NDA and manufacturing site disclosures that tie to quality and labeling.
| Step | Output | Decision use |
|---|---|---|
| NDC lookup | Labeler/manufacturer per strength | Confirms the actual market supply entity |
| Drugs@FDA | NDA/approval and product details | Confirms regulatory pedigree |
| Site matching | Manufacturing site GMP identity | Supports inspection and supply continuity analysis |
What distribution entities typically move SINEMET in the supply chain?
Distribution in the US typically runs through:
- Wholesale distributors that hold licenses and handle cold-chain status where relevant (not usually required for SINEMET)
- Pharmacy distribution networks
For diligence and procurement, the “distribution supplier” is usually validated through:
- Contracting documents (GPO/contract pharmacy)
- Shipment routing in logistics systems
- Wholesale licensing registries
Public registries identify companies licensed as wholesalers, but they do not consistently publish “who distributed exactly this NDC on these dates.” As a result, supply continuity analysis usually anchors on the manufacturer/labeler for the NDC, not on the one-week distribution path.
Supplier-risk considerations specific to carbidopa/levodopa brands
Sourcing risk concentrates in:
- API supply continuity for carbidopa and levodopa
- Single-site dependence for certain strengths if only one facility is tied to the active NDCs
- Regulatory scrutiny tied to inspection history at API and drug product facilities
Risk controls that buyer-side teams use:
- NDC-to-manufacturer mapping across time (confirm multiple sites per strength)
- Supplier qualification evidence (quality agreements, audit reports)
- Cold chain requirements (generally not required for SINEMET)
- Batch availability monitoring by NDC
Key Takeaways
- SINEMET is supplied to the market under a regulated NDC-specific labeler/manufacturer model; the brand owner/labeler in the US is AbbVie.
- Upstream “API suppliers” for carbidopa and levodopa are best identified through FDA DMF holders and manufacturing site references, then linked to the product through Drugs@FDA and NDC-specific manufacturer mapping.
- “Supplier” must be defined by chain layer. For procurement and regulatory diligence, the highest-confidence public anchor is NDC → manufacturer/labeler via FDA resources.
- Distribution entities vary by contract and routing; for high-stakes decisions, anchor supply continuity on the drug product manufacturer/labeler per NDC, then evaluate logistics separately.
FAQs
1) Is AbbVie the supplier of SINEMET?
AbbVie is the US brand labeler/marketing authorization holder for SINEMET. The specific manufacturer site for each strength is verified at the NDC level via FDA.
2) How can I identify the manufacturer for a specific SINEMET strength?
Use the product NDC in the FDA NDC Directory to extract the manufacturer tied to that exact strength/dosage form, then confirm in Drugs@FDA.
3) Who supplies carbidopa and levodopa APIs?
API suppliers are identified via FDA DMF holders and manufacturing sites for carbidopa and levodopa, then linked to the SINEMET NDA/product references in Drugs@FDA.
4) Do excipient suppliers change for SINEMET?
Yes. Excipients can shift by manufacturing site qualification and supply continuity. Publicly, you can confirm the approved excipient list in product labeling; vendor qualification is typically internal unless disclosed in filings.
5) Can I see distribution companies that shipped SINEMET by NDC publicly?
Not reliably at the shipment-event level. Distribution is usually handled through licensed wholesalers; buyer-side teams instead validate the drug product manufacturer/labeler per NDC and manage logistics via contracts and shipment tracking.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). NDC Directory. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMF). https://www.fda.gov/drugs/industry/drug-master-files-dmfs
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