Suppliers and packagers for DUOPA

DUOPA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DUOPA	carbidopa; levodopa	SUSPENSION;ENTERAL	203952	NDA	AbbVie Inc.	0074-3012-07	7 CARTRIDGE in 1 CARTON (0074-3012-07) / 100 mL in 1 CARTRIDGE	2015-01-15

Suppliers and packagers for DUOPA

Last updated: June 9, 2026

DUOPA suppliers: who manufactures Levodopa/Carbidopa intestinal gel and key upstream inputs

DUOPA (carbidopa/levodopa intestinal gel) is supplied in the US market through AbbVie, which markets the product. The DUOPA gel is manufactured under AbbVie’s supply chain and is dispensed using a branded Abbott/AbbVie-employed delivery platform (gel formulation plus intestinal infusion system). Upstream “supplier” mapping is concentrated around (1) API manufacture for carbidopa and levodopa, (2) sterile/aseptic filling of the intestinal gel, and (3) manufacturing of the infusion delivery kit used for administration.

Market framing

• Brand: DUOPA
• Active ingredients: levodopa + carbidopa
• Dosage form: carbidopa/levodopa intestinal gel for continuous intestinal infusion via pump
• US marketer: AbbVie (DUOPA is marketed by AbbVie; see FDA label)
• Administration system: DUOPA requires a dedicated infusion system/pump and intestinal access via PEG-J/jejunostomy per prescribing information (see FDA label)

Who supplies DUOPA in the US: AbbVie distributor vs actual manufacturing plant?

Answer: AbbVie is the listed marketer/sponsor for DUOPA on the FDA label, while the manufacturing and release activities occur through AbbVie’s contract/owned manufacturing network. FDA labeling identifies AbbVie as the holder of record and provides the prescribed supply/administration context; it does not list API raw-material vendors in the public label.

FDA label signals for “supplier” mapping

• Label holder (US): AbbVie
  Source: DUOPA prescribing information (FDA label) lists AbbVie as the manufacturer/distributor responsible for product information and labeling. (1)
• Product components:
  • Gel formulation for intestinal infusion
  • Delivery system for continuous infusion
    Source: DUOPA label discusses administration via pump/intestinal infusion. (1)

How to interpret “supplier” in DUOPA

For DUOPA, commercial “supplier” usually breaks down into:

1. Brand marketer and regulatory supplier (AbbVie)
2. Drug product manufacturer (gel manufacturing and aseptic/sterile control for gel)
3. API and excipient supply (levodopa, carbidopa, and gel excipients)
4. Delivery hardware supplier (pump/infusion set ecosystem used for intestinal delivery)

Public sources rarely identify the exact API/excipient vendor names on the label; they show the regulatory and product-level supplier.

What contract manufacturers make DUOPA (carbidopa/levodopa intestinal gel) and where is it filled?

Answer: Public FDA labeling establishes the label holder but does not reliably disclose specific contract manufacturing and fill-finish facility names for DUOPA in a way that can be used as a definitive “supplier list” for litigation-grade sourcing. The supplier-of-record approach is AbbVie at the product level, with manufacturing occurring in AbbVie’s qualified facilities or contracts.

What can be stated from public label and regulatory materials

• Product-level supplier-of-record: AbbVie (label) (1)
• Manufacturing and distribution responsibility: described at product-level by the label; site-specific fill information is typically in the “Manufactured for/Distributed by” sections when present, but those sections do not enumerate upstream API vendors. (1)

Which companies supply the DUOPA intestinal infusion pump and delivery kit?

Answer: DUOPA is administered via a dedicated intestinal infusion pump and associated accessories described in the prescribing information. The label points to the required delivery system but does not provide a public “bill of materials” vendor list for the pump components in a way that supports naming every underlying supplier.

Administration system requirements on the label

• DUOPA requires:
  • Continuous intestinal infusion through a jejunostomy/PEG-J
  • Use of a specific pump system for delivery of the gel (1)
• The pump/kit ecosystem is therefore not optional and functions as a gatekeeper for therapy access, even if drug product could be sourced elsewhere.

Who supplies DUOPA APIs: levodopa and carbidopa (upstream raw material vendors)?

Answer: The public DUOPA label does not name API suppliers for levodopa and carbidopa. In practice, API sourcing is managed through AbbVie’s procurement network and/or approved vendor qualification programs for carbidopa and levodopa.

Why API supplier names do not appear in public DUOPA label

• FDA labeling for DUOPA focuses on drug product prescribing, safety, and administration instructions, not raw material vendor identities. (1)

Commercial reality for sourcing

Even without public API-vendor names, downstream “supplier” risk is still driven by:

• API capacity and lead times for levodopa and carbidopa
• Controlled-quality excipient supply for intestinal gel stability
• Sterile/aseptic or clean-room fill-finish capacity (depending on DUOPA’s specified manufacturing controls in full CMC documentation)

How many suppliers are in the DUOPA supply chain: drug product, APIs, excipients, and delivery hardware

Answer: At a practical procurement level, DUOPA has multiple supplier layers:

• One primary drug product supply chain (AbbVie for regulatory and brand responsibility)
• Multiple qualified API and excipient suppliers (levodopa, carbidopa, gel excipients) under AbbVie’s qualification programs
• Delivery hardware supplier(s) for the pump and associated consumables used for intestinal infusion (described by the label)

The only supplier identity that can be stated definitively from public label content is AbbVie as marketer and label holder. (1)

What does the DUOPA FDA label say about manufacturers and distributors?

Answer: The DUOPA FDA label identifies AbbVie as the manufacturer/distributor responsible for labeling and product supply information. (1)

Label-derived supplier statements (high precision)

• Drug product: DUOPA carbidopa/levodopa intestinal gel is marketed under AbbVie’s label. (1)
• Administration: the label describes therapy administration via intestinal infusion with a pump and intestinal access. (1)

DUOPA sourcing vs generic/therapeutic alternatives: does any supplier substitution exist?

Answer: DUOPA’s unique administration requirement and specific gel formulation mean supplier substitution is constrained. If a competitor offers a different intestinal formulation or oral formulation, that changes the product category and regulatory status rather than creating a direct “same item” supply substitution.

Substitution risk drivers

• Same indication but different dosage form
• Different device system requirements
• Different formulation controls and clinical labeling

Key takeaways

• AbbVie is the regulatory label holder and market supplier for DUOPA in the US (FDA label). (1)
• The DUOPA supply chain includes upstream API/excipient vendors and downstream delivery hardware suppliers, but the public FDA label does not name specific API or hardware component vendors.
• For procurement, the actionable “supplier” entities are:
  • AbbVie for DUOPA drug product supply and regulatory responsibility
  • the required intestinal pump/delivery system ecosystem as specified in the DUOPA label (1)

FAQs

1) Who holds the DUOPA NDA and is responsible for product supply in the US?
AbbVie is identified as the manufacturer/distributor and label holder on the DUOPA FDA label. (1)

2) Does the DUOPA label list the specific API suppliers for levodopa and carbidopa?
No. The FDA label identifies the drug product and administration requirements, not raw-material vendor names. (1)

3) Is DUOPA supplied as gel only, or does it include the pump system?
DUOPA therapy uses an intestinal infusion pump/delivery system described in the prescribing information; DUOPA is the gel component, and administration requires the specified delivery system. (1)

4) Can a pharmacy substitute a different carbidopa/levodopa product for DUOPA without changing administration?
DUOPA is an intestinal gel requiring intestinal infusion via a pump, so substitution with other formulations is not equivalent for administration or labeling purposes. (1)

5) Where can I confirm DUOPA’s current US labeling supplier-of-record?
The DUOPA FDA prescribing information (label) identifies AbbVie as the manufacturer/distributor/label holder. (1)

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References

1. FDA. DUOPA (carbidopa and levodopa) intestinal gel, prescribing information (FDA label). U.S. Food and Drug Administration.