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

Suppliers for the Pharmaceutical Drug: Dronabinol

Last updated: July 27, 2025

Introduction

Dronabinol, a synthetic form of delta-9-tetrahydrocannabinol (THC), is approved for medical use in managing nausea and vomiting caused by chemotherapy and for stimulating appetite in AIDS-related cachexia. Its unique pharmacological profile—being a cannabinoid receptor agonist—culminates in a competitive market comprising various suppliers worldwide. This article explores the primary suppliers, manufacturing landscape, regulatory considerations, and market dynamics impacting dronabinol distribution.

Manufacturers and Suppliers of Dronabinol

1. Contract Manufacturers and Global Suppliers

The production of pharmaceutical-grade dronabinol necessitates specialized synthesis processes complying with Good Manufacturing Practices (GMP). Several pharmaceutical companies and contract manufacturing organizations (CMOs) serve as suppliers, either producing under license or direct manufacturing agreements.

• MediGene AG (Germany): Historically, MediGene has been involved in cannabinoid compounds, including dronabinol formulations, often serving as a supplier to larger pharmaceutical companies. Their operations focus on synthesis and formulation tailored for clinical and commercial distribution.

• AbbVie (USA): Although primarily conducting clinical research on cannabinoids, AbbVie has engaged in production and supply agreements concerning dronabinol, leveraging its extensive manufacturing infrastructure.

• Syndros (release by Insys Therapeutics, Inc.): While not a supplier in the traditional sense, Insys Therapeutics once marketed Syndros—a liquid formulation of dronabinol—selling in the US market. Production involves licensing agreements with manufacturers capable of GMP-compliant synthesis.

• Zynerba Pharmaceuticals: Focuses on cannabinoid-based treatments; however, its role is more research-oriented, with some involvement in sourcing nabiximols and formulations akin to dronabinol.

• Contract Manufacturers in India and China: Several CMOs in Asia, such as those operating under cGMP standards, produce synthetic cannabinoids including dronabinol to meet growing global demand, often supplying generics or off-patent versions.

2. Proprietary and Licensed Production

Dronabinol's origins trace back to synthetic cannabinoid research, with initial synthesis by laboratory and university research teams. Big pharmaceutical firms have since licensed production rights to secure supply.

• Sanofi: Past licensor of synthetic cannabinoid manufacturing processes, with some contracts cited for supplying active pharmaceutical ingredients (APIs).

• Laboratories with Licensing Agreements: Multiple regional labs worldwide hold licensing rights or have developed their own synthesis routes conforming to GMP standards for regulatory compliance.

Key Suppliers by Region

• United States: Patent-expired formulations like Marinol (by Solvay Pharmaceuticals, now part of AbbVie) historically served as the primary drug product. Active pharmaceutical ingredient production is handled by several US and international manufacturers.

• Europe: Companies like MediGene and Sanofi have contributed to the supply chain. Regulatory agencies such as EMA scrutinize manufacturing processes rigorously.

• Asia: A significant hub for generic and API production, with numerous facilities manufacturing dronabinol per international standards. Indian companies such as Suven Life Sciences and Jubilant Life Sciences have been involved in cannabinoid synthesis.

Market Dynamics and Regulatory Landscape

Regulatory Challenges

Dronabinol falls into controlled substance schedules (Schedule II in the US), complicating manufacturing, distribution, and licensing. Suppliers must navigate complex regulatory frameworks involving the DEA (Drug Enforcement Administration) in the US, EMA in Europe, and equivalent agencies worldwide.

GMP and Quality Standards

Manufacturers must adhere to GMP standards to ensure consistent potency, purity, and safety. This framework restricts the number of compliant suppliers and influences market entry barriers.

Supply Chain Constraints

Synthetic cannabinoid production faces challenges such as raw material sourcing, strict regulatory oversight, and legislative restrictions that limit global supply options. The shift toward generic production has increased the number of suppliers, yet capacity remains constrained due to compliance costs.

Emerging Trends

• Expansion of Licensed API Production: Post-2018, regulatory winds favor increased licensed API manufacturing, leading to more suppliers entering the market to meet demand.

• Development of Alternative Formulations: Liquid and spray formulations like Syndros and others are expanding the ways suppliers can deliver dronabinol, broadening the supplier landscape.

• Geopolitical Factors: International trade policies and drug enforcement laws influence supplier availability, especially in markets like Latin America, Southeast Asia, and Africa.

Conclusion

The supply of dronabinol comprises a complex ecosystem of pharmaceutical multinationals, CMOs, and regional manufacturers, all governed by stringent regulatory standards. While patented formulations are primarily supplied by established companies like AbbVie, the global market increasingly relies on licensed APIs from CMOs in Asia and Europe. The evolving regulatory landscape, coupled with rising medical demand, continues to shape the supplier dynamic, making market transparency and compliance strategic priorities for stakeholders.

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Key Takeaways

• Multiple suppliers—including multinational pharmaceutical companies, CMOs, and regional manufacturers—control the global supply of dronabinol.

• Regulatory approval and GMP compliance are critical gatekeepers, limiting the number of reliable suppliers.

• Asian CMOs play a vital role in API synthesis, providing cost-effective alternatives and increasing competition in the market.

• Licensing agreements and patent expirations have expanded the availability of generic dronabinol APIs.

• Stable supply chains depend on navigating complex legal frameworks, with ongoing advancements in formulation technology broadening supplier and product options.

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FAQs

1. Who are the leading suppliers of pharmaceutical-grade dronabinol globally?
Major suppliers include established pharmaceutical firms like AbbVie in the US, MediGene in Germany, and several licensed CMOs in Asia and Europe that produce APIs adhering to GMP standards, such as Jubilant Life Sciences and Suven Life Sciences.

2. What regulatory factors influence the supply of dronabinol?
As a Schedule II controlled substance in many jurisdictions, dronabinol manufacturing and distribution are tightly regulated by agencies such as the DEA (US) and EMA (Europe). These regulations impact licensing, manufacturing practices, and import/export processes.

3. Are there generic or non-branded sources of dronabinol available?
Yes. Patent expirations and licensing have facilitated the emergence of generic APIs produced by multiple Asian manufacturers, increasing competition and access.

4. How do geopolitical issues affect dronabinol supply?
Trade restrictions, drug enforcement laws, and licensing hurdles in certain countries can hinder API export/import, impacting global supply stability.

5. What are future trends in dronabinol suppliers?
Anticipated trends include increased licensing and API production in emerging markets, technological advancements in formulations, and greater regulatory harmonization promoting broader supplier participation.

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Sources:
[1] U.S. Food & Drug Administration. Marinol (dronabinol) prescribing information. 2022.
[2] European Medicines Agency. Dronabinol assessment report. 2021.
[3] Market research reports on pharmaceutical cannabinoids production and licensing trends.
[4] Regulatory frameworks for controlled substances—DEA, EMA, and respective national agencies.
[5] Public patent databases detailing licensing agreements and patent expirations relevant to dronabinol manufacturing.