Last updated: April 24, 2026
Who manufactures MARINOL (dronabinol) in the US?
MARINOL is the brand name for dronabinol (synthetic delta-9-tetrahydrocannabinol, Δ9-THC). In the US, MARINOL is marketed by AbbVie Inc. under FDA labeling for dronabinol capsules. [1]
The commercial supply base for MARINOL is typically organized as:
- Brand holder / NDA holder: responsible for drug substance (API) and drug product quality oversight and labeling.
- API and finished-dose manufacturers: contract manufacturers that can change over time by batch, site, and regulatory status.
- Excipients and capsule/packaging vendors: specialized suppliers whose identities may vary by batch and formulation site.
FDA labeling and drug registration data provide the only consistently auditable anchors for “who supplies what” at the product level; detailed supplier-site identities for MARINOL components are often controlled at the contractor level and not published comprehensively in public label text. [1]
What are the core “supplier categories” for MARINOL?
MARINOL’s supply chain breaks into four enforceable categories that drive procurement and quality controls:
1) Drug substance supplier (dronabinol API)
- Material: dronabinol (synthetic Δ9-THC) API
- Role: provides the active ingredient for capsule manufacture
- Control point: API CoA, GMP compliance, impurity profile, and traceability
Public sources that identify the specific API manufacturer for MARINOL batches are limited in open literature; the NDA/label identifies the product and dosing form, but not always the named API site. [1]
2) Finished-dose (drug product) manufacturer
- Material: MARINOL capsules (finished dosage form)
- Role: tablet/capsule manufacturing, blending, filling, packaging, and release testing
- Control point: batch release, cGMP manufacturing records, stability program
FDA labeling anchors the product and holder but not always the capsule filling site in a way that supports a definitive, named “supplier list” from the brand label text alone. [1]
3) Excipients and capsule shell suppliers
MARINOL capsule formulations include standard excipients and a capsule shell system (typical for soft/hard capsule technologies) that are qualified through vendor management. The excipient supplier identity can vary by manufacturing site.
4) Packaging and distribution suppliers
- Components: bottles/blisters, labels, cartons, tamper evidence
- Role: protects integrity and supports regulatory labeling requirements
- Control point: child-resistant packaging compliance, labeling accuracy, and chain-of-custody
Public label text is reliable for packaging identifiers but may not name all supplier companies. [1]
What does MARINOL’s labeling confirm about the supply chain?
FDA labeling for MARINOL supports the following supplier facts that are actionable for diligence:
Regulatory holder
- AbbVie Inc. is listed as the NDA holder/labeling entity for MARINOL. [1]
Product identity
- Drug: dronabinol
- Dosage form: capsules
- Brand: MARINOL
These are the only supplier-level facts that can be confirmed from the public label in a way that supports hard documentation. [1]
Practical procurement view: how to map “suppliers” for MARINOL
For R&D, sourcing, or investing, MARINOL supplier mapping should be executed by category, then confirmed against batch documentation and regulatory filings.
Category map
| Supply category |
What you need to verify |
What public sources reliably confirm |
| NDA/label holder |
Legal entity accountable for label and product |
AbbVie Inc. for MARINOL [1] |
| API manufacturer |
GMP site for dronabinol API, CoA issuer |
Often not named in label text [1] |
| Drug product manufacturer |
Capsule filling and release site |
Often not named in label text [1] |
| Excipients/capsule system |
Shell/excipient spec and traceability |
Not consistently named in public label [1] |
| Packaging |
Bottle/blister system and compliance |
Partial, label-dependent; vendor identities typically not named [1] |
What suppliers matter most for risk and continuity?
If your objective is supply security or substitution planning, focus on:
- API supply continuity for dronabinol (a controlled substance ingredient)
- GMP sites for finished capsule manufacture and batch release
- Child-resistant packaging and labeling execution capacity
These are the choke points that determine continuity, timeline, and batch acceptance.
Key Takeaways
- MARINOL is dronabinol (Δ9-THC) in capsule form, and AbbVie Inc. is the labeling/NDA holder for the brand in the US. [1]
- Public-facing sources consistently support holder-level supplier identity; API and capsule-filling site supplier names are not consistently disclosed in the label text in a way that supports a complete, authoritative “supplier list” from open materials alone. [1]
- For operational diligence, treat MARINOL sourcing as four categories: API, finished dose manufacturer, excipients/capsule system, and packaging/distribution, then confirm site-level facts against batch records and regulatory filings.
FAQs
1) Who is the NDA holder/label owner for MARINOL?
AbbVie Inc. [1]
2) What is the active ingredient in MARINOL?
Dronabinol (synthetic Δ9-tetrahydrocannabinol, Δ9-THC). [1]
3) Are MARINOL’s API and capsule-filling manufacturers named on the public label?
The public label reliably identifies the product and label holder, but does not consistently name specific API or drug product manufacturing suppliers. [1]
4) What supplier categories should be prioritized for continuity?
API supply, finished-dose manufacturing and batch release, and packaging/label execution. [1]
5) Is MARINOL sourcing tied to controlled-substance supply chain constraints?
Yes, because dronabinol is the controlled active ingredient; that is a key driver in API continuity and chain-of-custody controls. [1]
References
[1] FDA. (n.d.). MARINOL (dronabinol) prescribing information / label. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
