Suppliers and packagers for DRONABINOL

DRONABINOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ascent Pharms Inc	DRONABINOL	dronabinol	CAPSULE;ORAL	207421	ANDA	Lannett Company, Inc.	0527-4125-35	60 CAPSULE in 1 BOTTLE (0527-4125-35)	2020-02-10
Ascent Pharms Inc	DRONABINOL	dronabinol	CAPSULE;ORAL	207421	ANDA	Camber Pharmaceuticals Inc	31722-960-60	60 CAPSULE in 1 BOTTLE (31722-960-60)	2020-02-10
Ascent Pharms Inc	DRONABINOL	dronabinol	CAPSULE;ORAL	207421	ANDA	Camber Pharmaceuticals Inc	31722-961-60	60 CAPSULE in 1 BOTTLE (31722-961-60)	2020-02-10
Ascent Pharms Inc	DRONABINOL	dronabinol	CAPSULE;ORAL	207421	ANDA	Camber Pharmaceuticals Inc	31722-962-60	60 CAPSULE in 1 BOTTLE (31722-962-60)	2020-02-10
Svc Pharma	DRONABINOL	dronabinol	CAPSULE;ORAL	078292	ANDA	Rhodes Pharmaceuticals L.P.	42858-867-06	60 CAPSULE in 1 BOTTLE (42858-867-06)	2018-06-26

DRONABINOL: Key Suppliers Across the Value Chain

Last updated: April 23, 2026

What supplier categories matter for dronabinol procurement?

Dronabinol (synthetic THC; API-level substance or finished dosage forms) is sourced through a mix of regulated manufacturers and contract supply channels. In practice, buyer needs break into four supplier categories:

1. API manufacturers (synthetic dronabinol) for drug substance supply.
2. Finished-dose manufacturers for capsules or oral solutions (GMP drug product).
3. CMO services for formulation, filling, packaging, and tech transfer under GMP.
4. Distributors/wholesalers that handle licensed procurement and distribution of cannabinoid-controlled medicines.

Which companies supply dronabinol products in major markets?

Below are the most visible branded and/or commercial dronabinol supply channels by market. (These are the companies that hold the relevant product supply presence, which typically dictates downstream sourcing.)

Market / Product lane	Company	Role	Product / trade name (where applicable)	Evidence
US	Camber Pharmaceuticals	Manufacturer/distributor of dronabinol capsules (generic supply presence)	Dronabinol capsules (generic)	FDA Orange Book listing for “Dronabinol Capsules” shows marketed strengths and applicants tied to product listings; Camber appears as a listed manufacturer/applicant in US supply chain records. (FDA Orange Book, Dronabinol Capsules) [1]
US	Syndros brand commercial supply channel	Marketed dronabinol oral solution via 503(b)(2) route	Syndros (dronabinol oral solution)	FDA product listing for Syndros (dronabinol oral solution) identifies the marketed product and associated firm. (FDA Drugs@FDA, Syndros) [2]
EU/UK channel	Generic cannabinoid pharmaceutical suppliers	Often distributors to local wholesalers; API sourced from regulated manufacturers	National brand/generic variants	Dronabinol availability in Europe typically maps to local marketing authorizations that cite manufacturing sites and marketing authorization holders. (EMA and national registers) [3]

Who supplies dronabinol API (drug substance)?

For dronabinol, API sourcing is controlled by regulatory status and manufacturing qualification. Practical procurement in drug development and manufacturing typically targets suppliers that can provide:

• GMP drug substance (DMF/CEP-supported where applicable)
• Controlled substance compliance in shipping and storage
• Analytical package (CoA, stability commitments, impurity profile)
• Consistent stereochemistry and assay

At the dossier level, buyers typically validate API sources through:

• FDA DMFs tied to the molecule
• CEP dossiers (if used in specific jurisdictions)
• GMP inspection outcomes tied to manufacturing sites

The authoritative source for mapping specific API suppliers to approved US listings is the FDA Orange Book and related FDA dossier records linked to dronabinol products [1].

Because your request is “suppliers,” the actionable way to lock down API names is to trace from product listings (applicants/holders) to the underlying drug substance access route used by those products.

What are the main drug-product forms that drive supplier selection?

Supplier choice depends on whether you need API or finished dosage form.

Use case	Preferred supplier type	Typical dronabinol form	Sourcing impact
Clinical development requiring dose flexibility	CMO + API supplier	Oral solution or capsule-based compounding	Requires formulation capability and controlled substance handling
Commercial replication of approved products	Finished-dose manufacturer	Capsules and oral solution	Requires marketing-grade GMP and packaging validation
Generic market entry	Generic manufacturer with regulatory pathway	Capsules and oral solution	Requires bioequivalence package plus qualified API/finished product

What supplier constraints apply specifically to dronabinol?

Dronabinol is regulated as a cannabinoid medicine in most jurisdictions; procurement and supply chain qualification must support:

• Controlled substance licensing for storage and distribution (US: DEA and state requirements)
• GxP compliance for API and drug product handling
• Traceability through batch records and CoA/CoC documentation
• Validated packaging and transport meeting controlled-substance and pharmaceutical shipping rules

How to map dronabinol suppliers fast using FDA listings

The fastest, audit-ready way to identify “who supplies” for dronabinol is to anchor on the marketed drug listings and then capture the firms behind those listings:

1. Start at FDA Orange Book for dronabinol drug products to identify listed applicants/manufacturers for each strength/form.
2. Cross-check in Drugs@FDA for branded products (for the oral solution and any named capsules).
3. Pull manufacturing site identifiers from each product listing and then map the corresponding drug substance access route where the listing specifies it.

For dronabinol, these sources are:

• FDA Orange Book (drug product listing and applicant/manufacturer identifiers) [1]
• FDA Drugs@FDA (labelled drug records for marketed products, including branded oral solutions) [2]

Supplier shortlist (actionable starting set)

Given the procurement goal implied by your request (commercial supplier sourcing), the starting shortlist for dronabinol supply in the US is:

• Syndros supply channel: the marketed dronabinol oral solution record on Drugs@FDA identifies the responsible firm and label-controlled supply path [2].
• Dronabinol capsules supply channel: FDA Orange Book listings for “Dronabinol Capsules” identify marketed manufacturers/applicants that populate the generic supply chain [1].
• Distribution layer: wholesalers and licensed distributors procure from these manufacturers and manage controlled shipment and storage under their regulated distribution authorizations (buyer qualification depends on the destination jurisdiction).

Key Takeaways

• Dronabinol “supplier” identification works best by starting with FDA Orange Book and Drugs@FDA listings, then extracting the applicant/manufacturer identifiers behind marketed capsule and oral-solution products.
• In the US market, branded oral solution supply is anchored by Syndros listing records, while capsules are sourced through the FDA Orange Book “Dronabinol Capsules” applicant/manufacturer set [1], [2].
• API procurement is validated through dossier-backed supply chains tied to these marketed product listings, then confirmed via GMP and controlled-substance compliance for the intended jurisdiction.

FAQs

1) Is dronabinol supplied mainly as API or finished drug product?

Both exist. Finished product dominates market visibility in major jurisdictions; API suppliers are typically identified indirectly via product applicant/manufacturer records and dossier references tied to approved products.

2) What governs whether a supplier can ship dronabinol to a buyer?

Controlled substance licensing plus GxP compliance in manufacturing and distribution, including validated shipping and storage under the buyer’s jurisdictional requirements.

3) How do I identify the company responsible for a marketed dronabinol product?

Use FDA Drugs@FDA for branded products and FDA Orange Book for drug products to identify the applicant/manufacturer shown on the listing [1], [2].

4) Do dronabinol suppliers differ by dosage form?

Yes. Capsule manufacturing and oral-solution manufacturing are distinct product development and GMP lines, so supplier selection changes depending on whether you need capsules or solution.

5) Where can I confirm dronabinol supplier credentials?

Cross-reference the marketed product records on FDA with the manufacturing site and any dossier references tied to the listing, then qualify the supplier through audits and GMP documentation for the specific API or drug product.

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References

[1] U.S. Food and Drug Administration. (n.d.). Drug Products (Orange Book): Dronabinol Capsules. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Syndros (dronabinol oral solution). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[3] European Medicines Agency. (n.d.). European public assessment reports (EPAR) and medicine registers for dronabinol-containing products. EMA. https://www.ema.europa.eu/